Clomid and Birth Defects

I would like to comment on the use of the fertility drug, Clomid, for those women who were curious about the risk of birth defects, and give them the benefit of my 30+ years of research in the subject. Clomid has a long half-life and is biologically active up to 54 days after it is ingested. It is thus present during the development of the embryo, even when the drug was taken prior to conception. Clomid also impairs the production of cholesterol, similar to Lipitor and other statin drugs, which is vital to the proper formation of human cells. There are also several peer-reviewed studies in the published literature demonstrating an increased risk of congenital malformations with the use of Clomid.

Among the many studies cited see the papers by Reefhuis, et al. (2003), who found a 280% increased risk of craniosynostosis; Wu, et al. (2006), who found over a 10-fold increased risk in spina bifida; and Meijer, et al. (2006), who found a 508% increased risk of penoscrotal hypospadias. In a still-unpublished study (currently submitted for publication), the CDC presented the results of its findings from the National Birth Defects Prevention Study at the Teratology Society convention on July 2, 2008. They found a 170% increased risk of anencephaly; a 140% increased risk of limb reduction defects; a 200% increased risk of esophageal atresia; and 110% increased risk of hypospadias. Importantly, each of these studies involved Clomid (clomiphene citrate) and their data were statistically significant (e.g., the probability of occurring by chance was at 5% or less). There is also a means of reducing this risk while using fertility drugs.

[msteri]

With all of the increased risks listed, I count myself lucky that my baby was born healthy with no defects.  Do you reveal on your website how to reduce the risk while using fertility drugs without having to purchase your book?  You did say you were giving the women who use Clomid the benefit of your 30+ years of research, yet you didn't share the most important information that could help them.  All of those statistics are impressive, but I'm much more interested in learning how to reduce the risks of my baby having any of those defects.  Thanks for any additional FREE information you can provide.

[TerenceMix]

The means of reducing the risk of birth defects while on Clomid is only covered in my book because it reveals the research upon which it is based - covered in a full chapter - and it is important to have a full understanding of that research, not only to effectively utilize it for the safety of the baby-to-be, but also to make an informed decision on using it. The studies upon which it is based are on the cutting edge of genetic research. The book also explains that this should always be done working closely with your OB/GYN.

That being said, the key is maintaining an adequate level of CHOLESTEROL before using and while on Clomid. One of the side effects of Clomid is that it impairs the production of cholesterol by acting on enzymes in your body, similar to the way cholesterol-reducing drugs do. Children born with these enzymes that are defective - and thus cannot produce sufficient levels of cholesterol - are born with a wide array of birth defects, such as children with Smith-Lemli-Opitz syndrome (SLOS). Women of child-bearing age are warned to use birth control methods while on statin drugs for the same reason. Whether a woman has naturally low cholesterol levels or has low levels because of her vegan or vegetarian diet would likely place her at a higher risk from Clomid (further reducing that level) than a woman with high cholesterol levels. Clomid also might be more effective at lowering cholesterol in one woman than another. An individual embryo may not need as much maternal cholesterol as another and thus be more resistant to having birth defects as a result of it. These are some of the variables that dictate why at least 90% of the pregnancies due to Clomid will result in normal babies.

The most important variable, however, relates to the MOST EFFECTIVE AND OPTIMUM LEVEL OF TOTAL CHOLESTEROL TO MINIMIZE THE RISK. Animal studies have clearly shown that reducing cholesterol - whether by using a cholesterol-reducing drug or by altering genes - produces birth defects in the offspring. Studies have also demonstrated that by administering cholesterol to a pregnant animal AT THE SAME TIME as a cholesterol-reducing drug eliminates the birth defects caused in the same species of animal when given the cholesterol-reducing drug alone. Human studies, however, are lacking on this issue because of the ground-breaking
nature of this research and because clinical studies can take years to complete. The most important published study to date was by Edison, et al, (2007), who found that women at a total cholesterol level of less than 159 (mg/dl) DURING THE SECOND TRIMESTER had an increased risk of babies having a PREMATURE DELIVERY and term babies with LOW BIRTH WEIGHT. They also found a trend toward microcephaly (undersized cranium and brain). The critical period for birth defects, of course, is the FIRST trimester - especially the first 8 weeks (e.g., the embryonic period). This would suggest that women should maintain a total cholesterol level (before and while on Clomid) of at least above 160, and perhaps significantly higher. And again, this should always be done under the guidance of your OB/GYN.

I sincerely hope that this is useful, as my ultimate goal has always been - and will always be - to see healthy and normal babies.