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helping ireland to concieve
Pre~Seed and TTC FAQs
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We have taken our communities most often asked questions on male fertility, how to enjoy intercourse while baby-making, and how to optimize Pre~Seed® use and posted answers or information here for you. Thanks for being a part of our Pre~Seed® family and happy baby-making!

bullet Cervical Mucus Quality, Clomid and Sperm Transport?
bullet Declining Fertility with Age in Men
bullet What can be done to help the chances of conceiving for older men?
bullet Pre~Seed® User Survey Reports (2005 and 2010)
bullet How Long to Abstain for a Sperm Test/Analysis
bullet Why Does Pre~Seed® Have Parabens in it?
bullet Irritation or Infection with Pre~Seed
bullet Picking a doctor for male fertility
bullet Safe Lubricant Use While Trying to Conceive
bullet Sperm Chromatin Assay
bullet Sperm Leaking Out After Intercourse – Is This Normal?
bullet Infertility with Abnormal Sperm Analysis
bullet Using a Sperm Collection Condom
bullet Top 4 Reasons For Failing To Conceive

Cervical Mucus Quality, Clomid and Sperm Transport?

After ejaculation, sperm have to be able to swim through the cervix to reach the Fallopian Tube where fertilization of the egg occurs. The sperm that can fertilize the egg begin leaving the ejaculate within 1 min after deposition, and no sperm that get to the Fallopian Tube have ever been proven to do so after 30 min of ejaculation. The "cervical reservoir" of sperm is not an actual pool of fertilizing sperm.

Sperm have to get thru cervical mucus (CM) to get to the Fallopian tube where they are then stored for hours to days until the egg comes. However, the interactions of sperm and cervical mucus that allow this migration are often disrupted in fertility patients. It is thought that at least a third (if not more) of subfertile couples have some disruption of sperm-cervical mucus interactions that limit sperm transport to the tubes.

The importance of normal CM in natural reproduction is widely recognized. For most of a woman’s cycle the CM is a thick gel and hostile to sperm, with a low pH and a structure that stops sperm transport by the presence of closely spaced microfibers. During ovulation, however, the CM becomes more alkaline (higher pH), and the fibers align in parallel with an expanded distance between them. This allows the sperm to swim through the mucus. Normally, the volume of daily CM also increases 5 fold at ovulation. CM is a hydrogel of 90% water, and its primary function appears to be bathing sperm in a fluid medium to protect them during transport. The presence of sugar-proteins in the gel that hold the water is controlled by hormone changes at ovulation (especially the presence of estrogen). These sugars increase the mucus gel’s capacity to hold water, expand fiber spacing, & allow sperm migration. Taken together, these changes permit sperm to rapidly swim through the cervix and proceed to the Fallopian tube for fertilization.

In women with poor sperm-CM interaction there is a reduction in CM fiber spacing making sperm migration difficult, a primary cause of which in many women may be inadequate water in the gel. This may be caused by advancing age (with low grade hormonal disruptions), and following the use of fertility medication such as clomiphene citrate (CC or clomid). CC is a widely prescribed fertility drug. In fact, it has become increasingly used as a first- line therapy for couples with fertility issues. With easy internet access, many women are also taking CC without doctor oversight. Estimates are that 40% of couples with fertility problems utilize CC at some point for the woman. Although its wide spread use has helped many couples conceive, it does cause significant problems with vaginal dryness, CM production and function. Specifically, numerous studies have shown that CC causes decreases in: volumes of CM; quality of CM (“egg-white like appearance”); and sperm penetration into CM. In fact, women on CC are seven times more likely to have “hostile” CM that is difficult for sperm to penetrate than are women not on the medication.

Women on CC also have an increased prevalence of vaginal dryness which can cause pain at intercourse and decrease enjoyment for the man (which can decrease sperm counts). Many women on CC (which is already making them prone to poor sperm-cervical mucus penetration) are therefore also using lubricants that can harm sperm. These women may be creating a vaginal environment that limits sperm transport. Pre~Seed® can replenish vaginal moisture without harming sperm.

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Declining Fertility with Age in Men

Declining fertility with age is not just a female issue. We all know about the increased risks of infertility or birth defects in older women who want to have a child and are aware that these risks are due to chromosome changes in the egg that occur as women age. However, as with most things reproductive, the medical community has lagged far behind in evaluating the effect of aging in men on sperm quality. Several recent studies have begun to paint a picture of aging of the male reproductive tract which is very similar to that seen in women.

Specifically, in a study of 2,000 couples (Hassan & Killick, Fertility & Sterility, June 2003), men that were over 45 years of age had a five-fold increase in time to pregnancy for their partners (how long it took them to become pregnant) as compared to younger men. This effect was seen even after taking into account the variables of their wife’s age, how often they had intercourse and whether or not they had fertility-adverse lifestyles (smoking, drinking, etc.). Even older men who had very young wives (<25 yrs of age) had a four-fold increase in time to pregnancy.

In this study, 57% of these 2,000 unselected couples became pregnant within 3 months of trying to conceive, and 81% after 1 year. The average time to pregnancy increased from 7 months in men that were 25 years of age or younger and to 37 months in men that were over 45 years of age.

Other work suggests that similar to the changes seen in women, these delays in fertility may be due to DNA or chromosomal abnormalities in the sperm of older men. Singh et al (Fertility & Sterility, Dec 2003) found that the DNA of sperm in men ages 36-57 had far more breakage in the strands than did sperm from men ages 20-35. These strand breaks have been associated with infertility, early embryo losses, miscarriages and even birth defects or cancer in children.

Another study (Sloter et al., Fertility & Sterility, April 2004) also showed age-related increases in the number of sperm with broken or damaged DNA for men, especially sperm with structural chromosomal abnormalities. This study suggested that these changes may be due to environmental toxin damage or a loss of internal antioxidants in semen in aging individuals.

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What can be done to help the chances of conceiving for older men?

Be sure and have a sperm chromatin assay done in addition to a normal semen analysis (visit www.scsadiagnostics.com to learn more), so that you know if sperm DNA damage is present. We highly recommend this test for older men, especially because many older “dads-to-be” are on medications which may cause DNA strand breaks (e.g., antidepressants, cholesterol lowering drugs, etc.).

When providing a semen sample for testing or for clinical procedures, use Pre~Seed® as a sperm-friendly lubricant to help make semen sample collection more pleasant. This is important because the more enjoyable ejaculation is, the more normal sperm a man can produce for these samples!

There is also a growing body of evidence that vitamins with antioxidants help men with low fertility. Numerous studies have found that infertile men do not make enough of their own antioxidants in their semen to protect sperm on their journey at ejaculation and through the cervix. INGfertility® did a study on FertilAid vitamins and found that this antioxidant-containing fertility vitamin increased total motile sperm counts for some men. We do recommend that all TTC men take fertility vitamins while TTC.

Make sure you have intercourse timed with ovulation to optimize the chances of sperm and egg meeting. Ovulation prediction tests, as well as tracking cervical mucus quality, are effective ways to know when to get busy “baby-making.” Having intercourse every other day during your fertile window, up to your first day of “dry” (or less) cervical mucus, will make sure you cover the bases.

Vaginal dryness and a lack of secretions during your fertile window makes intercourse uncomfortable and can interfere with fertility. Supplementing your secretions with Pre~Seed® makes “baby-making” more fun. Better feeling intercourse can increase sperm production! So take that time for at least one session during your fertile window to have “Gourmet Sex”—the long, relaxed, “we love each other” kind!

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Pre~Seed® User Survey Reports (2005 and 2010)

2010 Pre~Seed® User Survey Results

134 people completed over 30 detailed questions in a self-reporting, opt-in internet survey. Women were recruited through social media and chat room sites. Data are not a clinical study or necessarily reflective of the broader population. An emphasis of this survey was learning more about women who used Pre~Seed® specifically because of poor quality cervical fluids/mucus.

Trying-to-conceive women in our survey used Pre~Seed® because of inadequate vaginal secretions, including cervical fluids, based on the following personal needs:
  • 44% to relieve dryness and discomfort during intercourse
  • 35% to supplement low quality cervical fluid
  • 52% to supplement too little quantity of cervical fluid
A total of 87 women used Pre~Seed® for poor quality cervical fluids with 81% of these women saying it increased their cervical fluid quality; and 64% saying it improved their cervical fluid quantity.
  • 58% of women who took this survey, became pregnant while using Pre~Seed®
  • Of women with poor quality cervical fluid, 57% became pregnant while using Pre-Seed®
  • 75% of women used Pre~Seed® twice or more during their fertile time
  • 30% of users became pregnant the first time they used Pre~Seed®
  • 15% the second time and 10% after 4 or more cycles
  • 11% of women who reported having poor quality or quantity of cervical fluids reported having a male problem also
  • 93% of users applied Pre~Seed® inside the vagina
  • 57% of users had been trying to conceive for 7 or more months before using Pre~Seed®
  • 40% of babies were a boy
  • 38% of babies were a girl
  • 20% of first pregnancies were lost (consistent with the 25-38% of all first trimester pregnancies lost in the general population)
  • There were no multiple pregnancies in this group of survey responders
These results support the value of Pre~Seed® to relieve dryness and supplement vaginal secretions involved in reproduction, including cervical fluids. This is the third survey we have done in the past 7 years showing no gender differences in pregnancy outcomes for women using Pre~Seed®.

Almost 1/3 of users became pregnant the first time they used Pre~Seed®, even though a majority of users had been trying to conceive for more than half a year prior to using it.

2005 Pre~Seed® User Survey Results

The following data is from 100 self-reporting Pre~Seed® users, responding to an internet request for information in May and June, 2005. This is a self-responding survey, and there are no controls for comparison (i.e., couples not using Pre~Seed®) so it is NOT in any way a scientific study. But it has some interesting information!

These self-reported findings include:
  • 31% of respondents became pregnant using Pre~Seed®.
This broke down into pregnancies in:
  • 30% of couples who had been trying for 0- 2 months;
  • 40% of couples trying for 3-6 months;
  • 23% of couples trying for 7-12 months; and
  • 31% of couples trying for one year or more.
This is in comparison to population studies suggesting a maximum pregnancy rate per cycle of 30% in presumed “fertile” couples over the first 2 cycles which then declines over the following cycles (Zinaman et al., Fertil Steril, 1996).
  • 65% of these became pregnant in the first two cycles of use, and 35% became pregnant after 3 or more cycles of use.
  • 51% of our users started using Pre~Seed® after they had been trying to conceive for 7 or more months, and 54% of all folks who became pregnant had been trying to conceive for 7 or more months before they started using Pre~Seed®
The pregnancies reported resulted in:
  • 17% a boy
  • 19% a girl
  • 35% reported no gender
  • 29% had a lost pregnancy (miscarriage), including early “chemical” losses. The miscarriage rate is very consistent with pregnancy losses reported in other studies (31% - Wilcox et al., NEJM, 1988; 33% - Wang et al., Fertil Steril, 2003).
25% of all couples using Pre~Seed® had undiagnosed infertility, 26% had diagnosed male factor issues, and 34% had diagnosed female factor issues. Further, 25% were taking Clomid and 16% other fertility medications. For couples that became pregnant, this was 15% undiagnosed, 19% male factor, 23% female factor, with 21% on Clomid and 21% on other fertility medications. 45% mentioned no infertility diagnosis.

84% of users liked “the way Pre~Seed® feels” well enough to want to use it as their regular lubricant if a more cost effective version were available for non-fertile times.
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How Long to Abstain for a Sperm Test/Analysis

Recent studies suggest that abstaining for a sperm test or a procedure such as IUI/IVF should be limited to no more than 1- 2 days. The first study looked at men with abnormal sperm (oligospermic) and found the best sperm quality occurred at 1 day of waiting or abstaining prior to production. For men with normal sperm waiting more than 10 days between productions resulted in abnormal sperm quality.

In the second study that looked at functional quality (i.e., “did the sperm result in an artificial insemination IUI pregnancy”), they found:

”Abstinence correlated positively with inseminate sperm count but negatively with motility.”

Meaning that abstinence increased sperm count but lowered motility... who cares about the number of sperm if they can't swim!

”Variations in inseminate parameters did not correlate with pregnancy rates.”

How the sperm looked on testing did not relate to pregnancy outcomes - discussed in the FAQ on doing sperm analysis. However, abstinence intervals significantly affected pregnancy rates.

”The time of abstinence impacted outcome. Couples that had 10 or more days of waiting had only a 3% pregnancy rate!”

Based on these studies, 1-2 days wait before production is probably best.

References:
Relationship between the duration of sexual abstinence and semen quality: analysis of 9,489 semen samples. Fertil Steril. 2005 Jun;83(6):1680-6.

Effect of ejaculatory abstinence period on the pregnancy rate after intrauterine insemination. Fertil Steril. 2005 Sep;84(3):678-81.

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Why Does Pre~Seed® Have Parabens in it?

Preservatives, such as methylparaben and propylparaben (in Pre~Seed®) keep products from growing bacteria. Unfortunately, other preservatives can cause sperm damage (Vitamin C as an acid, EDTA, etc.). We chose to use methylparaben and propylparaben in our isotonic vaginal dryness relief products (Pre~Seed® & Pre’®) because they have very long histories of use and safety data. Other parabens (such as butylparaben) have been shown to be mildly estrogenic at high doses, although some of the studies on this have since been refuted.

The studies as to Pre~Seed®’s effect on sperm and embryos have been done by several third party universities, and include no effect of the product on human sperm motility, fertilization of embryos in vitro (animal model) or subsequent embryo development even at 50% concentrations of the Pre~Seed® in the dish at the time of fertilization. In fact, Pre~Seed® maintained sperm DNA quality in the laboratory versus other lubricants that damaged sperm DNA. You can see reviews of these studies at our Science page.

Additionally, bacterial byproducts called endotoxins can damage sperm and the female reproductive tract (Fallopian tube), as well as causing complications with pregnancy. We pride ourselves on the low level of endotoxin allowed (<2 EU/ml) in Pre~Seed®. Other lubricants, especially “natural product” ones, can have much higher endotoxins levels, some as high as 700 EU/ml! So this is why we have a preservative.

Methylparaben and propylparaben are low active parabens (see articles below) with NO activity on sperm production (one of the most sensitive indicators). A recent toxicology review (article below) states that it does not appear possible to intake enough parabens through product use to surpass any estrogenic activity from dietary estrogens. Most importantly, this should include not eating commercial meat (with the hormone injections) and avoiding the higher order parabens such as butyl. Further, in a study where they cultured parabens directly with sperm in a dish (no body metabolism or dilution) methylparaben had no adverse effect on sperm until it reached high levels. The active level in this study for the propylparaben was 3 mg/ml. Our products have concentration far below any adverse level, even in this extreme condition of direct culture contact.

The studies can be reviewed below:

A review of the endocrine activity of parabens and implications for potential risks to human health.
Crit Rev Toxicol. 2005 Jun;35(5):435-58.
Golden R, Gandy J, Vollmer G. ToxLogic LC, Potomac, Maryland 20854, USA. RGolden124@aol.com.

Parabens are a group of the alkyl esters of p-hydroxybenzoic acid and typically include methylparaben, ethylparaben, propylparaben, butylparaben, isobutylparaben, isopropylparaben, and benzylparaben. Parabens (or their salts) are widely used as preservatives in cosmetics, toiletries, and pharmaceuticals due to their relatively low toxicity profile and a long history of safe use. Testing of parabens has revealed to varying degrees that individual paraben compounds have weakly estrogenic activity in some in vitro screening tests, such as ligand binding to the estrogen receptor, regulation of CAT gene expression, and proliferation of MCF-7 cells. Reported in vivo effects include increased uterine weight (i.e., butyl-, isobutyl-, and benzylparaben) and male reproductive-tract effects (i.e., butyl- and propylparaben). However, in relation to estrogen as a control during in vivo studies, the parabens with activity are many orders of magnitude less active than estrogen. While exposure to sufficient doses of exogenous estrogen can increase the risk of certain adverse effects, the presumption that similar risks might also result from exposure to endocrine-active chemicals (EACs) with far weaker activity is still speculative. In assessing the likelihood that exposure to weakly active EACs might be etiologically associated with adverse effects due to an endocrine-mediated mode of action, it is paramount to consider both the doses and the potency of such compounds in comparison with estrogen. In this review, a comparative approach involving both dose and potency is used to assess whether in utero or adult exposure to parabens might be associated with adverse effects mediated via an estrogen-modulating mode of action. In utilizing this approach, the paraben doses required to produce estrogenic effects in vivo are compared with the doses of either 17beta-estradiol or diethylstilbestrol (DES) that are well established in their ability to affect endocrine activity. Where possible and appropriate, emphasis is placed on direct comparisons with human data with either 17beta-estradiol or DES, since this does not require extrapolation from animal data with the uncertainties inherent in such comparisons. Based on these comparisons using worst-case assumptions pertaining to total daily exposures to parabens and dose/potency comparisons with both human and animal no-observed-effect levels (NOELs) and lowest-observed-effect levels (LOELs) for estrogen or DES, it is biologically implausible that parabens could increase the risk of any estrogen-mediated endpoint, including effects on the male reproductive tract or breast cancer. Additional analysis based on the concept of a hygiene-based margin of safety (HBMOS), a comparative approach for assessing the estrogen activities of weakly active EACs, demonstrates that worst-case daily exposure to parabens would present substantially less risk relative to exposure to naturally occurring EACs in the diet such as the phytoestrogen daidzein.

Effects of propyl paraben on the male reproductive system.
Food Chem Toxicol. 2002 Dec;40(12):1807-13.
Oishi S. Department of Toxicology, Tokyo Metropolitan Research Laboratory of Public Health, 3-24-1, Hyakunin-cho, Shinjuku-ku, Japan. oishi@tokyo-eiken.go.jp.

Parabens are p-hydroxybenzoic acid ester compounds widely used as preservatives in foods, cosmetics, toiletries and pharmaceuticals. These compounds exert a weak estrogenic activity as determined by in vitro estrogen receptor assay and in vivo uterotrophic assay. In a previous study, it was demonstrated by the present author that exposure of post-weaning mammals to butyl paraben adversely affects the secretion of testosterone and the function of the male reproductive system. In the present study, it is shown that propyl paraben also adversely affects the hormonal secretion and the male reproductive functions. Propyl paraben was administered to 3-week-old rats which were divided into four groups of eight animals each, at doses of 0.00, 0.01, 0.10 and 1.00% with the AIN93G modified diet. At the end of 4 weeks, the rats were sacrificed by decapitation and the weights of testes, epididymides, prostates, seminal vesicles and preputial glands were determined. There were no treatment-related effects of propyl paraben on the organ weights in any of the study groups. The cauda epididymal sperm reserves and concentrations decreased in a dose-dependent manner and the difference was significant at dose of 0.10% and above. Daily sperm production and its efficiency in the testis of all groups receiving propyl paraben significantly decreased. The serum testosterone concentration decreased in a dose-dependent manner and the decrease was significant in the group that received the highest dose. The exposure level at which this effect was observed is the same as the upper-limit acceptable daily intake (10 mg/kg body weight/day) of parabens in the European Community and Japan.

In vitro spermicidal activity of parabens against human spermatozoa.
Contraception. 1989 Mar;39(3):331-5.
Song BL, Li HY, Peng DR. Tianjin Family Planning Research Institute, People's Republic of China.

Potent in vitro spermicidal activity of parabens against human spermatozoa was demonstrated in this study. The "pass" point concentration of the four parabens--methylparaben, ethylparaben, propylparaben, and butylparaben, at which all spermatozoa were immobilized and no immobilized spermatozoon revived after 30 min incubation in phosphate buffered glucose solution, was 6, 8, 3, and 1 mg/ml, respectively, as tested by Harris' method. These parabens are used as food and pharmaceutic preservatives; less toxicity and side effects were expected for the development of parabens as vaginal contraceptive agents.

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Irritation or Infection with Pre~Seed

In general, many women are able to use Pre~Seed® that develop irritation or an infection after using other lubricants. This is most often due to the fact that other lubricants do not have the same ion concentrations as your body fluids. For example, body fluids are at about 270 mOsmo ions, but other lubricants are as high as 3,500 mOsmo, so you can see VERY high. It is basically like getting salt water in your eyes!

Several vulvodynia (pelvic pain) clinics use our products Pre~Seed® and Pré® as well. A published study found that Pre~Seed®’s formula was the less irritating than the three leading lubricants.

All this said, a very, very low percent of women do have some irritation after use of Pre~Seed® or Pré. The rate is about 1/2 of 1%, based on the records we keep.

Reactions can be associated with:

1) Early pregnancy (for some reason soon after conception) in about 25% of women that have a reaction. If you have a reaction, you may want to assume you are pregnant until you know you are not!

2) Women having the wrong pH of their cervical mucus. Normally your CM should go from a low pH of about 4-5 to a pH of 7-8 at ovulation (the same pH as semen and as our products). This is controlled by hormones. If you don't have the right hormone changes, your CM may not make this change on a monthly basis. Therefore, your CM could cause harm to sperm. But also, the normal bacteria in your vagina do not go thru the changes that the pH shift can cause. The change in pH with an introduction of Pre~Seed® may cause a change in bacteria and a yeast infection to occur. However, remember that it is normal for the woman’s vaginal pH to elevate during her fertile time, to the same pH as Pre~Seed® or semen; or

3) An allergic reaction to the ingredients in our products. Again, we have tested this product for hypersensitivity in rabbits (applied daily for 10 days) and in people (wearing Pre-Seed® under a patch for 30 days), with no allergies or irritation seen. However, of course some people will still have reactions.

All our products carry our “Love it or it’s Free” guarantee, so if for any reason you are not happy with Pre~Seed® or if you have any concerns using the product, please contact us!

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Picking a doctor for male fertility

Men's Health Best Life from March, 2006 had a GREAT quote about choosing a physician to help with male fertility issues!

"In other fields (of medicine), fundamental expertise is relatively easy to gauge. A cardiologist can't treat heart patients unless he is board certified in cardiology; a doctor can't go by the title "oncologist" unless he's trained to treat various forms of cancer. But many urologists can and do treat male infertility without ever having received specialized training in reproductive medicine. ‘Make sure your doctor has that extra fellowship training,’ says Jon Pryor, MD chair of urology at University of Minnesota School of Medicine. ‘After all, who's better at fixing a Volvo - a dealer or the mechanic down the street?’”

“Ask your doctor what percentage of his practice is infertility related. ‘It should be at least 1/3,’ says Jay Sandlow, MD, vice chair of urology at Medical College of Wisconsin. ‘Also ask him what societies he belongs to. If "andrology" "infertility" or "sexual" isn't in the title, then he's not active in the field and probably doesn't keep up with the latest advances.’…”

Another alternative to a Urologist is the Clinical Andrologist. These are often PhDs that study sperm physiology and male reproduction. You should always ask if your RE clinic has a Clinical Andrologist on staff, what level of education they have (a PhD is preferred), and if they belong to the American Society of Andrology. Also, confirm that any clinic you work with adheres to World Health Organization guidelines for sperm analysis... if they don't, shop elsewhere or ask for a referral specifically for the male partner elsewhere.

REs versus Andrologists
Subfertility (which is now the preferred term over "infertility") is a medical problem that must be investigated based on the couple, not either partner in isolation. Subfertility is frequently multi-factorial, (i.e., involving more than one contributory factor), and frequently contributory factors are present in both the man and the woman at the same time (about half of all subfertile couples, based on the most recent research). Moreover, there are many aspects to the whole process of getting sperm from the site of insemination in the upper vagina to the site of fertilization in the ampulla of the Fallopian tube (oviduct), as well as in the complex sequence of events whereby the sperm and egg interact and fertilization takes place, that cannot be evaluated by currently available medical or laboratory tests. Indeed, the process of gamete transport and interaction is still not fully understood, and it should be no surprise that we still have many situations where the cause of a couple's infertility cannot be identified: this is called "unexplained" or "idiopathic" subfertility, and can affect as many as 30% of couples who seek medical advice for perceived subfertility.

Fellowship training in reproductive endocrinology typically takes place in departments of obstetrics & gynecology where there is frequently very limited expertise in examining the man and investigating male factors that contribute to, or cause, subfertility. Also, the great majority of urologists have not specialized in this area, their medical specialty being defined as "that part of medical science that deals with diseases and abnormalities of the urinary tract and their treatment." For this reason, thorough subfertility work-up should include someone trained in investigating the male reproductive system, an "andrologist," who has knowledge and expertise complementary to that of a gynecologist trained in reproductive endocrinology and infertility.

Since the advent of intra-cytoplasmic sperm injection ("ICSI"), whereby fertilization can be achieved in vitro by injecting a single sperm cell into an egg, many subfertility doctors simply look at the man as being a source of sperm, and have the couple undergo assisted reproductive technology treatment ("ART") without worrying about diagnosing or attempting to treat cases of "male factor subfertility" directly. While this can certainly be seen as a quick way to achieve a pregnancy, it might not be the cheapest, or safest, means of doing so. However, such medical management decisions must always be taken by a physician fully trained in all aspects of subfertility diagnosis and treatment, and specific advice cannot be provided outside of such a patient-doctor relationship. Nonetheless, from a scientific perspective, it is clear that many "infertility doctors" could benefit from more extensive, or more recent, training in male reproductive biology and medicine. This opinion is based on the many patients who have received advice that is contrary to the recommendations of the World Health Organization's Manual for the Standardized Investigation, Diagnosis and Management of the Infertile Male, which is intended as a "lowest common denominator " approach to investigating and managing subfertile couples with a male factor, that can be applied everywhere, including Third World countries.

Unfortunately, there is no simple way for a couple to verify that their managing physician has proper expertise in clinical andrology, but patients must never be afraid to ask questions, perhaps especially about the nature of their doctor's training and expertise in clinical andrology, and about what options other than ICSI have been considered and might be available to them. As a generalization, based on experience from centres where andrology is integrated into their operation, only 35 to 40% of ART treatment cycles actually need ICSI

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Safe Lubricant Use While Trying to Conceive

At least six million couples in the US have medically defined infertility (about 15%), meaning they have had unprotected intercourse for over one year without a successful pregnancy. A common complication for these trying-to-conceive couples (“TTC”) is vaginal dryness in the female partner, with 75% of these couples reporting increased incidence of vaginal dryness due to: the stress of being infertile; having to have timed intercourse; and/or fertility medications they are taking. Enjoying intercourse can become difficult during daily sexual activity when vaginal dryness and pain become an issue. In fact, over 25% of TTC couples “always” use lubricants while having intercourse (e.g., an estimated 2.25 million Americans).

Vaginal dryness is routinely treated with vaginal lubricants. However, three decades of peer reviewed, published research has shown that all existing vaginal lubricants studied to date harm sperm, resulting in rapid losses in their motility (% swimming). Specifically, there have been at least 11 studies on this topic conducted in medical school settings, reviewing the effect of 16 different lubricants on sperm, including all of the top selling brands, such as K-Y®, Astroglide® and Replens®. In each study, sperm motility and viability were dramatically reduced after exposure to even small concentrations (<6%) of these products.

Specific data from these studies show:
  • A spermicidal or sperm killing activity of the leading three brands of lubricants equivalent to contraceptive jellies such as Gynol. In these studies, sperm had ZERO motility after 30 minutes of contact with the top three selling lubricant products.
  • These effects are concentration dependent and were seen even with low concentrations (1–6%) depending on the lubricant product.
  • Critically, the negative effect of lubricants on sperm includes decreasing sperm penetration into the cervix in women after intercourse.
In order for conception to occur, motile sperm must be able to penetrate into cervical mucus and proceed to the Fallopian tubes in adequate numbers. Existing lubricant products rapidly decrease sperm motility and numbers of sperm penetrating into the cervix, thus potentially limiting the number of sperm able to participate in fertilization. The following quotes from these lubricant studies highlight the investigators’ deep concerns with the use of vaginal lubricants by TTC couples (a list of these studies is at the Clinical Studies page).
  • Dept of ObGyn, University of Texas Southwestern Medical Center: “For couples with infertility, the use of vaginal lubricants during intercourse is not recommended.”
  • Dept of ObGyn, University of Connecticut: “We conclude that all traditional vaginal lubricants should be avoided in patients desiring conception.”
  • Dept of ObGyn, University of Minnesota: “The spermicidal effect of the lubricants was statistically significant. The lubricants had a similar effect on both normal and abnormal semen specimens.”
  • Dept of ObGyn, Uniformed Service University, Bethesda, MD: “In vivo [in people] data demonstrated severe impairment to sperm penetration of mid-cycle human cervical mucus by the lubricant.”
Why do lubricants harm sperm? The best pH value for sperm migration and survival in cervical mucus has been established by the World Health Organization at between 7.1 and 8.5. This coincides with the normal rise in pH of cervical mucus found in women at the time of ovulation. In contrast, vaginal lubricants tend to have pH values below 7, and often as much as half of this value. These pH values can cause sperm death. Sperm are also sensitive to both high and low osmolality (concentration of osmotically active particles in solution) because these can cause the cells to either shrink or swell too much. A physiologic osmolality around 320 mOsmo/kg (that of semen) is best for sperm function. Sperm motility decreases with exposure to increasing osmolality, with all motion stopping at 600 mOsmo or greater. Lubricants have osmolality levels 3-10 times that of semen that causes irreversible damage to sperm motility at contact. Additionally, some ingredients in lubricants are directly toxic, such as glycerin or glycol. Glycerin penetrates across the sperm membrane and goes inside the sperm cell. Even at very low concentrations (e.g., 2%) it can disrupt normal sperm function and motility, especially at room or body temperatures.

In spite of the numerous publications cited above, there remains a great deal of confusion amongst physicians and lay people alike as to the safety of vaginal lubricant use while trying to become pregnant. In fact, many doctors are inadvertently recommending lubricants that harm sperm to their patients based on inaccurate information. In many cases there is a fundamental disconnect between the published data of the effects of lubricants on sperm function and the physician’s knowledge. A common misconception is that if a lubricant does not contain a spermicide or if it is water soluble, it will not impair sperm function. Unfortunately, this is completely inaccurate. Water-based lubricants often have glycerin (which has been shown to be toxic to sperm) and propylene glycol, both of which are highly hyperosmotic. This results in irreversible damage to sperm and a loss in motility after exposure to commercial lubricants. Damage to sperm and subsequent inability of the sperm to penetrate into the cervix following contact with lubricants may prevent conception in some couples, resulting in consequences such as undesired childlessness or the advancement to more invasive advanced reproduction technologies (all of which carry added economic costs and medical risks). If there is any evidence that a vaginal lubricant can interfere or limit a couple’s fertility, it should carry a warning label to avoid its use while trying to conceive, and testing needs to be established for any products that claim to not harm sperm.

In contrast, Pre~Seed® Intimate Moisturizer was developed in response to the need for a safe lubricant that does not harm sperm while couples are trying to conceive. Each lot is tested to ensure no sperm damage before it is sold. So if you are trying to conceive, know the facts about vaginal lubricants. Most damage sperm and should be avoided. If you need help with dryness, as many couples do, Pre~Seed® was developed specifically to match fertile cervical mucus, by a Sperm Physiologist and is safe to use when trying to conceive!

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Sperm Chromatin Assay

The Sperm Chromatin Structure Assay (SCSA) is an assessment of sperm DNA fragmentation that identifies men with highly reduced probability of initiating and supporting a successful pregnancy. The percentage of sperm in a semen sample with fragmented DNA is reported as the DNA fragmentation index (%DFI).
The SCSA can help answer difficult questions regarding fertility options based on the health of the sperm DNA. After the SCSA analysis is completed, a Clinical Report is generated with the percent of damaged sperm (%DFI). Containing. The %DFI number will place the patient in one of the following three groups:

< 15% DFI = excellent sperm DNA integrity
> 15 to < 30% DFI = good sperm DNA integrity
> 30% DFI = fair to poor sperm DNA integrity

It is important to note that a DFI value above 30% does not preclude a normal, full term pregnancy. A >30% DFI, if consistent over time, does mean that the male partner is statistically placed into a group of men that demonstrate a longer time period to establish a pregnancy, more IVF/ICSI cycles, increased risk of spontaneous abortions or no pregnancy.
Even with a normal semen analysis showing normal levels of sperm concentration, motility and morphology, men can have high levels of DNA fragmentation. Sperm that appear to be completely normal by all the standard measurements may have high levels of DNA fragmentation.

Some conditions that might indicate the need for an SCSA test include:
  • abnormal semen analysis
  • unexplained infertility
  • persistent infertility after treatment of female
  • recurrent miscarriage
  • prior to assisted reproductive technologies
  • cancer in male: before and after treatment
  • advancing male age, e.g., ~ age >45
  • varicocele
A recently published meta-analysis for SCSA data and pregnancy outcomes showed that couples have a 10 times, 8 times, 2 times, and 1.5 times greater probability of a successful pregnancy by natural, IUI, routine IVF and ICSI fertilizations, respectively, if the semen samples contains < 30% DFI.

DNA fragmentation in sperm may be the result of many factors including, but not limited to, disease, diet, drug use, high fever, elevated testicular temperature, air pollution, cigarette smoking, some prescription medications, varicocele and advanced age. In about 50% of infertile couples, male-factors play a significant role in infertility.

Current conclusions of an international review by Erenpreiss et al. (2006) state: “Without doubt the existing data justify the necessity to introduce sperm DNA damage assessment into the routine infertility investigation. The SCSA is currently the only method that has provided clear clinical cut-off levels and that can be recommended for a robust sperm DNA damage evaluation%.”

To have the test done, SCSA Diagnostics sends a sperm shipping container and all of the necessary supplies to your physician's office or directly to your home. The sample collection, packaging and shipping procedures are simple and completely explained on the SCSA website (www.scsadiagnostics.com) as well as in the instructions provided. Patients typically have very few questions and do not make mistakes. The results of your SCSA analysis are sent to your physician within one week of receiving your sample at SCSA Diagnostics.
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Sperm Leaking Out After Intercourse – Is This Normal?

In a 5 yr study of 11 women (Baker & Bellis, 1993), sperm loss after intercourse ("flow back") was observed. Flow back occurred 94% of the time, with an average loss of 35% of the sperm. It is totally normal and is not a sign that there is anything wrong. It is more pronounced the larger the ejaculate volume, and remember ejaculate quantity is impacted by "how turned on" your husband is. So if you have a great session, or it has been awhile since doing the deed, there will be more semen and flow back.
The sperm that penetrate into the cervical mucus begin to do so within 1.5 min after deposit in the vagina, and all those who are going to swim to the Fallopian tube to participate in fertilization are gone within 30 minutes, with no gain in sperm numbers in the cervical mucus or Fallopian tubes after 45 min from intercourse. Only thousands of the millions of sperm ejaculated in the vagina make it to the cervix and only hundreds of these make it to the Fallopian tube!

The very best of the best get there, the rest get washed out - it’s OK!

Sperm analysis or tests are a critical part of finding out why a couple may not be conceiving. Male low fertility is usually involved about 60% of the time, with 40% of the time the man being the main cause and 20% of couples having shared male and female issues.

First of all, the results of a sperm analysis are your medical records, and you have the right to review them and keep a copy. You also have the right to a good conversation about what was found. I am surprised how often people don't get reports back or how poorly the material is reported back. YOU need to be aggressive about talking to your doctor and understanding what they found. YOU also have the responsibility of making sure your clinic is using state of the art methods to look at the man’s sperm. If not, find another clinic! One recent study showed that only 30% OF ALL CLINICS doing sperm tests in this study had accurate readings of motility and morphology.

That said, it is important to understand that there is NO sperm test that can tell you if a couple will conceive or not except if there are no sperm in a man's semen  then, of course, the chance is zero.

There have been thousands of studies with everyone wanting a magic bullet that says, "This ejaculate can make a baby; this one cannot." NO SUCH test exists.

What we do have are studies relating various quality sperm to various levels of fecundity (this means the chance of conceiving). Men with normal sperm parameters in regards to count, motility, and morphology (shape) tend to have normal chances of impregnating their wives (20-30% chance each month), although other things can be wrong with sperm that appear normal at sperm analysis. The chromatin (DNA) can be damaged, there can be antibodies, etc., meaning that just because the man has a normal basic sperm analysis does NOT guarantee he is "fertile." Many couples with unexplained infertility have stopped evaluating the man because he has normal parameters on a semen analysis. This is not good medicine.

On the other side, an abnormal sperm count does not mean your husband is sterilesterile means NO functional sperm in the ejaculate. It truly does only take one normal sperm, and we have all heard of couples that could not conceive for years and years due to male factor, who suddenly do become pregnant. Lower quality sperm, meaning outside of average, means your fecundity or chance of conceiving each cycle drops. There is one recent study with Dr. Kruger as an author (i.e., Kruger's strict morphology criteria) that studied all the other studies and basically said that you can break ejaculate quality into "fertile" or "subfertile" based on "thresholds of <5% normal sperm morphology, a concentration <15 x 10(6)/ml, and a motility <30% should be used to identify the subfertile male.”

You will note that this study used the strict criteria for morphology. Other forms of looking at sperm shape are not as accurate or predictive of subfertility.

Subfertile doesn't mean sterile; it means your chances are less, and as you move to worse and worse quality, the chances continue to decline somewhat.

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Infertility with Abnormal Sperm Analysis

If you have this situation you need to repeat the sperm analysis to confirm accuracy. A recent study showed that sperm motility and counts differed AMAZINGLY for monthly sampling over a year from the same guy. Four times, even 17 times, the number of sperm were seen in different ejaculates from the same man. The only parameter that did not vary was the percent of morphologically normal sperm - the shapes. The one caveat here is that these guys all collected into a cup, probably dry-handed (without lubricant). Numerous other studies have shown that you can improve the normal morphology percent using collection into a condom during intercourse based on the man being more sexually stimulated and ejaculating more fully.

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Using a Sperm Collection Condom

Millions of sperm samples are processed each year for both diagnostic procedures (to determine sperm quality in a man) and therapeutic interventions, such as intrauterine insemination (IUI) and in vitro fertilization (IVF). The majority of these samples are collected manually by masturbation. However, this method can cause a great deal of stress in men, and it can lead to production of inferior sperm samples, with lower sperm counts and motility resulting. Whether men morally object to masturbation to collect semen or if the whole process of performance "on demand" is too much to allow for good sample collection, numerous studies have shown that collecting sperm in a condom during intercourse is an excellent alternative to masturbation.

Data Supporting Sperm Collection Using Condoms at Intercourse

Studies over the last three decades have shown that sperm quality can be strongly impacted by collection method, especially in oligospermic men (men with low sperm counts). A review of the published literature shows that total sperm counts, sperm motility, and the percentage of sperm with normal morphology are often 2-3 times higher in samples collected in condoms at intercourse than by masturbation in the same men (Sofikitis & Miyagawa, Journal of Andrology, 1993). In fact, in one study (Zavos, Fertility & Sterility, 1985), 38% of the patients that were classified as having low sperm counts based on masturbated sperm samples were reclassified as normal after semen collection at intercourse in a condom. Furthermore, in this study, the total functional sperm fraction (numbers of normally shaped motile sperm in the sample) increased by 190% in oligospermic patients and 69% in normospermic men.
In these studies sexual satisfaction at collection is also greatly increased, lessening the stress of the collection process. In fact, in one study patients preferred condom use so much over masturbation that the scientists had to stop randomizing collection method and only have men collect at intercourse AFTER the masturbation collections were done, or the men would stop participating in the study!

In general, all studies comparing masturbation to condom collection of sperm have found that those sperm parameters historically associated with and related to fertility show improved outcomes when collected into condoms at intercourse. Sperm samples collected by masturbation, therefore, do not represent the optimum quality sample a man can produce and may lead to diagnostic mistakes and/or lowered success rates in assisted reproduction.

This is especially important for sperm samples to be used in assisted reproduction techniques such as IUI, where total motile sperm count critically impacts successful outcomes. For men with borderline sperm sample quality, using a condom at intercourse instead of masturbation could provide significant clinical benefit by increasing the potential fecundity rate (the chance of conceiving per cycle) as the number of motile sperm inseminated is increased.

These previous studies have led one clinician to write, "It appears that for cervical cap insemination, intrauterine insemination, and IVF, coitus condomatus (collection into a condom) is preferable to regular masturbation" (Gerris, Human Reproduction Update,1999). He further concludes that for "artificial reproductive technology, masturbation as a method for semen collection should not be recommended."

Specially Designed Condoms for Sperm Collection

Almost all commercially available condoms are made of latex. Latex condoms have been shown to be toxic to sperm and never should be used for sperm sample collection. In contrast, polyurethane condoms manufactured by Apex Medical Technologies (San Diego, CA), called the "Male Factor Pak" are safe for sperm collection.

Previous Problems with Sperm Collection Condoms

pIn spite of all of the studies discussed above, many people are unaware of the possibility of using a special condom during intercourse with their partner for sample collection. Part of the reason for this is that many doctors became discouraged with these condoms due to patient frustration with them. In the past, patients had a difficult time using the condoms due to vaginal dryness and lack of lubrication, leading to pain and performance issues. Previously available vaginal lubricants harm sperm and could not be used with the condoms. This made both intercourse and removal of the condom difficult and at times painful. I am aware of numerous couples who tried the semen collection condoms, only to have to stop during intercourse because of pain from the lack of lubrication.p

A Solution to Non-lubricated Semen Collection Condoms

Pre~Seed® Lubricant has been specially formulated to not harm sperm while providing lubrication. It can be applied to both the vulva and penis, and inside the condom to facilitate intercourse and sample collection. Pre~Seed® has been tested and is compatible with the Apex condoms.
Couples who plan to use condoms to enhance sperm quality for assisted reproduction procedures such as IUI should practice at least once with the condom and Pre~Seed® to learn how to best use the system, without the stress of the procedure hanging over them. Additionally, a new (but very small) study has suggested that it is best if couples can get their semen sample to the laboratory 30 minutes after collection. For couples who live a distance from their clinic, renting a hotel room may offer a more romantic and enjoyable experience for condom collection than having to rush out the door at home. Finally, individuals need to make sure their laboratory has experience with sperm samples in condoms. They will need to rinse the condom in order to optimize sperm recovery. It is perfectly acceptable for anyone to ask to have this done!

Assisted reproduction procedures, such as IUI, all have tremendously variable outcomes based on the clinic and technique used. In general, cumulative pregnancy rates for 3 cycles of IUI should equal rates of an IVF cycle at around 25%. Three cycles of IUI is actually more cost effective for couples with unexplained infertility and moderate male factor infertility, than IVF. The most important thing a couple can do to optimize their chances for conception is to increase the number of motile sperm in the ejaculate. The best option for doing that is likely through condom collection of sperm at intercourse - where the couple can function as a team; the way it was meant to be!

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Top 4 Reasons For Failing To Conceive

Over 75% of the time, couples that are not conceiving (that are infertile) have one of the following 4 problems. If you are younger than 35 yrs of age (for the woman), have these checked out if you have not conceived in a year. If you are 35 yrs old or older, after 6 months of trying you may want to get checked out!
  • Poor Sperm Quality: At least 50% of the time, when a couple is not conceiving there is some component of abnormal or poor quality sperm. This may be all of the problem or partially the problem (both the man and the woman are contributing). A sperm analysis should be done by someone trained as an Andrologist or a Fertility Urologist, and done using World Health Organization Standards. If the man’s test is abnormal, repeat it once more to confirm the results. Also, remember with guys, quality counts! The better intercourse feels for him and the more foreplay, the MORE sperm the man can make. Pre~Seed® can help here to make things slippery fun!
  • Abnormal Cycle: This often has to do with hormonal abnormalities, and can be seen as failure to ovulate or cycle normally, or chemical pregnancy and losses. Working with an ObGyn or RE to evaluate how your ovaries are functioning is critical. While you are waiting, keep a careful, detailed log of when you have your period, when you have any ovulation mucus, and any other information on your cycle. The very best book on monitoring this is Toni Weschler’s book Taking Charge of Your Fertility.
  • Tubal Problems: Many women have blocked tubes which keep the sperm and egg from meeting. The only way to know if this is the case is to have special testing done. In general, couples often wait too long to have this testing. It can be helpful to know what is going on, and in some cases the testing itself can help promote conception. Especially if you have had a history of Chlamydia or bacterial vaginosis, have this checked!
  • Poorly Timed Intercourse: Many couples do not have intercourse at the right time. Specifically, some women ovulate a little later than OPKs suggest. So they are quitting the baby dance too soon. If you are unsure at all, regular intercourse 2-3 times a week has been shown to be almost as effective as every day well timed intercourse. Too many couples have daily sex for 2-3 days early on at ovulation and then stop, only to have actually missed her peak time.

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