Fertility Drugs and Birth Defects:
The Problem and the Solution
Did you Know...
…that on July 2, 2008, the Centers for Disease Control (CDC) reported the results of a 7-year study in which they found that that the use of Clomid (clomiphene citrate) was associated with a 170% increased risk of being born without a brain (anencephaly) and a 140% increased risk of being born without limbs?
…that in January 2008, a study was published in an international peer-reviewed journal in which they found that the use of clomiphene citrate was associated with a 350% increased risk of being born with a neural tube defect (including anencephaly and spina bifida) and a 540% increased risk if the drug also caused ovarian cysts?
…that in October 2006, a study was published in a scientific journal demonstrating that the use of clomiphene citrate was associated with a 1070% increased the risk of having a baby born with a spinal neural tube defect (spina bifida)?
…that these are just a few of the published studies and birth defects that have been found at an increased risk when using clomiphene citrate and other fertility drugs, all identified in the award-winning book, The Price of Ovulation?
If this subject has your interest, please read on...
The Problem
Whether the drug is CLOMID (clomiphene citrate), SEROPHENE (clomiphene citrate), PERGONAL (human menopausal gonadotropin/hMG), PREGNYL (human chorionic gonadotropin/hCG), or any other fertility drug that has the common side effects of multiple births, elevated estrogen levels and ovarian hyperstimulation syndrome, they all increase the risk of birth defects.
For decades, assurances of safety have been made about these drugs to dispel any concern that they might present a risk to the developing embryo. Although the strongest evidence of such a risk has been reported in scientific journals within the past ten years, incriminating studies have existed for decades – studies that have never been revealed to the general public or users of fertility drugs.
Up to 750,000 women per year in the United States use fertility drugs to conceive,(1) including their use during In Vitro Fertilization (IVF) and other Assisted Reproductive Technology (ART) procedures. In fact, of women currently between the ages of 15 and 44, it is estimated that 2,524,000 of them have used fertility drugs during their lifetimes.(2) Here is what they have been hearing…
| Assurances of Safety | | The Truth | - Clomiphene citrate is administered prior to conception and thus cannot present a risk to the developing embryo.
| | Clomiphene citrate has a long half- life and can be found in the feces as late as 6 weeks after ingestion.(3) It has been found to be biologically active for a period of up to 54 days after consumption (4) and can accumulate over multiple consecutive courses of treatment.(5) It is thus present during the embryonic period of development when conception occurs during a treatment cycle.(6)
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- During the pre-market clinical investigations with clomiphene citrate, the reported birth defects “occurred at an incidence within the range reported for the general population.” – Clomid package insert
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The pre-market clinical investigations with clomiphene citrate were never designed to assess the risk of birth defects,(7) and the actual number of children born with birth defects from these studies is unknown. (8) |
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- “Clomiphene has never been incriminated in causing the development of birth defects.” – Palo Alto Medical Association
- “The % of congenital birth defects in children conceived with the assistance of Clomid is no different than the % of congenital malformations in the general population.” – The Clomid Club
- “The incidence of birth defects, stillbirths, or even miscarriage is not increased with Clomid.” – Connecticut Fertility Association
- “Overall, no current research has found that a child conceived with the help of clomiphene citrate has a higher risk of birth defects….” – The Mayo Clinic
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Among other studies, Wu, et al (2006)(9) found a 1070% increased risk of spina bifida following the use of clomiphene citrate, and a 644% increased risk when considering all fertility drugs; Meijer, et al. (2006)(10) found a 508% increased risk of hypospadias following the use of clomiphene citrate; Reefhuis, et al. (2003)(11) found a 280% increased risk of craniosynostosis following the use of clomiphene citrate; Mili, et al. (1991)(12) found a 239% increased risk of atresia or stenosis of the colon rectum or anus and a 404% increased risk of microcephaly following the use of clomiphene citrate; and Czeizel (1989)(13) found a 609% creased risk of cleft palate and/or cleft lip following the use of clomiphene citrate. |
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- “There is not an increased risk of birth defects in children conceived through IVF.” – San Diego Fertility Center
- “We now have ample data that children conceived through IVF have no increase in these rates of birth defects.”
– Pacific Fertility Center
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IVF procedures use fertility drugs to produce the ova (eggs), which are then inseminated in a test tube. Hansen, et al. (2002) (14) found a 114% increased risk of major birth defects following IVF; Merlob, et al.(2005)(15) found a 130% increased risk of major birth defects between 1986 and 1994 and 75% increased risk between 1995 and 2002 following IVF; and Olson, et al. (2005)(16) found a 41% increased risk of major birth defects following IVF.
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The Solution
For prospective parents desiring children of their own through the use of fertility drugs, but not wanting to expose their unborn babies to the increased risk of catastrophic birth defects, there is a solution to this dilemma. Having discovered how fertility drugs steal a vital ingredient needed by an embryo to form its organs, the author of The Price of Ovulation also learned of an effective means to essentially offset this risk – a means validated through preliminary scientific studies, and involving nothing more than ingesting a nutritional dietary product through the first two months of pregnancy.
- 2002 National Survey of Family Growth (64.1% of 1,169,659 seeking treatment to conceive during the prior year; see Tables 97 and 98).
- Ibid (185,000 using ART; 2,339,000 using fertility drugs alone).
- Clomid and Serophene package inserts.
- Geier, et al. Fertility and Sterility 47(5): 778-784, May 1987.
- Mikkelson, et al. Fertility and Sterility 46(3): 392-396, September 1986.
- Since 1995 the Clomid package insert has stated, “it is possible that some active drug may remain in the body during early pregnancy in women who conceive in the menstrual cycle during CLOMID therapy.”
- Deposition testimony from Carl Bunde, M.D., the Medical Director for Richardson-Merrell, Inc., who oversaw the pre-market clinical investigations for clomiphene citrate (1960-1967).
- Among their many deficiencies, these studies failed to require autopsies on stillborns and neonatal deaths; failed to conduct follow-up examinations (after delivery) of children born as a result of clomiphene therapy; and used numerous clinical investigators (fertility specialists) who did not deliver and examine the babies from the study and relied upon receiving unsolicited reports from outside physicians and, in many instances, from the patients themselves, to determine whether a child was born normal or with a congenital defect. Evidence has also been unearthed that many spontaneous abortions (due to a defective embryo or fetus) and birth defects from these studies went unreported.
- Birth Defects Research (Part A), 76: 718-722, 2006; spina bifida is non-closure of a portion of the spinal column, often with exposure of the spinal cord. It is among a group of anomalies called neural tube defects.
- Birth Defects Research (Part A), 76(4): 249-252, 2006; hypospadias exists when the urethral opening of the penis is located beneath the shaft rather than the tip.
- Pediatrics, 111(5): 1163-1166, May 2003; craniosynostosis exists when there is premature fusion of the cranial sutures (fibrous joints between the bones of the skull). Left untreated, it can lead to microcephaly (smaller than normal brain and cranium) and mental retardation.
- American Journal of Epidemiology, 134: 748, October 1991; atresia is lack of an opening and stenosis is abnormal narrowing. Anal atresia is also known as imperforate anus.
- The Lancet, 2: 167, July 15, 1989; cleft palate and/or cleft lip involve an opening in the roof of the mouth and/or the lip.
- New England Journal of Medicine, 346(10): 725-730, March 2002.
- European Journal of Medical Genetics, 48(1): 5-11, Jan.-Mar. 2005.
- Fertility and Sterility, 84(5): 1308-1315, November 2005.
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