Is it safe to use ovulation pills, such as clomiphene citrate, during pregnancy?

Clomiphene Citrate Use During Pregnancy

Clomiphene citrate is contraindicated during pregnancy as it offers no benefit and poses potential risks to the developing fetus. 1

Safety Profile and Contraindication

• Clomiphene citrate is specifically designed for ovulation induction in infertile women and has no therapeutic role during pregnancy 1, 2
• The FDA drug label explicitly states that "clomiphene citrate use in pregnant women is contraindicated" 1
• Clomiphene citrate should be discontinued before conception occurs, as it is only intended for ovulation induction 3, 2

Potential Risks

• Animal reproductive toxicology studies have shown increased embryo-fetal loss and structural malformations in offspring exposed to clomiphene citrate 1
• In animal studies, oral administration of clomiphene citrate to pregnant rats during organogenesis resulted in hydramnion, weak/edematous fetuses, and temporary bone changes 1
• Higher doses in animal studies caused increased resorptions, fetal death, dystocia, and delayed parturition 1

Avoiding Inadvertent Use During Pregnancy

• To prevent accidental use during pregnancy, appropriate tests should be performed during each treatment cycle to determine whether ovulation and/or pregnancy occurs 1
• Women should be evaluated carefully between treatment cycles to exclude pregnancy before starting another course of clomiphene citrate 1
• Like other medications that affect hormonal balance, clomiphene citrate should be discontinued when planning pregnancy 3

Human Data on Exposure

• While available human epidemiologic data do not show a clear cause-and-effect relationship between clomiphene periconceptual exposure and increased risk of overall birth defects, the studies have limitations 1
• These studies were only able to rule out large differences in risk and could not adjust for important confounders related to subfertility 1
• The drug label notes that among spontaneously reported birth anomalies since commercial availability, there has been a high proportion of neural tube defects among pregnancies associated with clomiphene-induced ovulation, though population-based studies have not supported this finding 1

Alternative Approaches

• For women who are already pregnant and experiencing conditions that might otherwise be treated with ovulation-inducing medications, other pregnancy-compatible medications should be considered 3
• Medications used during pregnancy should always prioritize maternal benefit against potential fetal risk 4

Important Clinical Considerations

• Approximately 90% of pregnant women use medications during pregnancy, and about 10% of all birth defects are directly linked to medications taken during pregnancy 5
• When treating infertility, it's important to confirm the absence of pregnancy before initiating or continuing clomiphene citrate therapy 1, 2
• Clomiphene citrate should be used for ovulation induction prior to conception, not during pregnancy 1, 6

In conclusion, clomiphene citrate has no therapeutic role during pregnancy and is explicitly contraindicated by the FDA drug label. The medication should be discontinued once pregnancy is confirmed, and alternative treatments should be sought for any conditions arising during pregnancy.