You'll find hundreds of files on cleft lip, cleft palate here on

This one is about: Is Clomid Involved in Clefting?

(c) 1996 Wide Smiles
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Full text of manufacturers info on Clomid (Pharmaceutical Studies) can be viewed at WS-494.html

The only thing that can be said for sure is that some children born to women who have taken clomid have clefts.

Based on the info given in the manufacturers human studies .. there were babies born with clefts in their studies. It occurred in less than 1%. No specific # given. If you compare this to general US population risk is 1 in 700 or 0.14%

It seems a bit higher.

Perhaps in some susceptible women in plays a role in the mulitfactorial nature of clefting.. perhaps not. Perhaps what also needs to be studied is the characteristics of infertile couples and their underlying causes of infertility. There is nothing written in black or white. There are women who had children conceived with clomid where the first child was born with a cleft, and the second was not.

Look at the manufacturer's information, plus a 1983 study (below) that showed NO overall risk. Below it, is a 1994 study that suggests it needs to be studied more. An epidemiology study in France did note a higher association of clefting in women who had undergone ovulation stimulation.

Fertil Steril 40: 187-189 (1983)

Congenital malformations of newborn infants after clomiphene-induced ovulation.

Kurachi K, Aono T, Minagawa J, Miyake A

The effect of clomiphene citrate (CC) on the incidence of congenital malformations in newborn infants was assessed from the outcome of 1034 pregnancies after CC-induced ovulation recorded at nine university hospitals in a 5-year period.  Of these pregnancies, 14.2% ended in abortion, 0.5% in ectopic pregnancy, 0.1% in molar pregnancy, and 1.6% in stillbirth. In all, 935 infants were born, and 21 (2.3%) showed visible malformations. This incidence of malformations was not significantly different from that in 30,033 infants (1.7%) after spontaneous ovulation (spontaneous ovulation group), and the types of malformations after CC treatment were similar to those in the spontaneous ovulation group. This data indicates that CC has no teratogenic effect.


Aust N Z J Obstet Gynaecol 34: 56-66 (1994)

Clomiphene citrate and pregnancy outcome.

Venn A, Lumley J

Centre for the Study of Mothers' and Children's Health, Monash University,
Carlton, Victoria.

Data from Australia and elsewhere have shown consistently that adverse perinatal outcomes such as preterm birth and perinatal mortality are more common in pregnancies resulting from assisted conception with IVF and GIFT than normally conceived pregnancies. Factors that may contribute to the excess of poor outcomes include maternal factors, the assisted conception procedures themselves and possibly the influence of drugs used to induce superovulation. This review examines the medical literature describing pregnancies following ovulation induction with one of the drugs used to induce superovulation, clomiphene citrate, and compares their outcomes with Australian IVF and GIFT pregnancy outcomes. The review shows that while some studies have suggested higher rates of ectopic pregnancy, spontaneous abortion and congenital malformations in clomiphene citrate induced pregnancies, the findings are inconsistent and the data are flawed. There is only very poor data available on the incidence of preterm birth. Multiple pregnancy is a well-recognized adverse outcome of clomiphene citrate induced pregnancies. Attempts to improve perinatal outcomes of pregnancies following assisted conception will be helped by a better understanding of the relative contributions of maternal and treatment factors and further studies of pregnancy outcome after ovulation induction are needed.

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