With the up to date published data, the risk of clomiphene exposure du
ring pregnancy cannot be determined. After a review of animal experime
ntation results, we will discuss the human data. Most of the publicati
ons with human exposition concern treatments given before the beginnin
g of pregnancy. The questions addressed to the Centre de Pharmacovigil
ance of Paris F. Widal will be detailed. From May 1983 to July 1995 39
requests are available with only 25 cases of known outcomes. For thes
e 25 cases, five elective terminations and three spontaneous abortions
are reported. Only one defect was observed among the 17 births (9 fem
ales, 8 males) : unilateral fibula agenesis the imputability of which
is difficult to establish. These data seems reassuring; however, the n
umber of patients studied is small. Other studies on clomiphene-expose
d pregnancies are necessary in order to investigate this risk.