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The overall incidence of reported birth anomalies from pregnancies associated with maternal Clomid ingestion during clinical studies was within the range of that reported for the general population. Thus, 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. Pelvic examination is necessary prior to Clomid treatment and before each subsequent course (see CONTRAINDICATIONS and WARNINGS). Once ovulation has been established, each course of Clomid should be started on or about the 5th day of the cycle. Although no causative evidence of a deleterious effect of Clomid therapy on the human fetus has been established, there have been reports of birth anomalies which, during clinical studies, occurred at an incidence within the range reported for the general population (see Fetal/Neonatal Anomalies and Mortality; ADVERSE REACTIONS).

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