Objective: To investigate the efficacy of clomiphene citrate (CC) on n
ormally ovulatory women who complained of infertility. Design: A rando
mized study. Setting: University Hospital. Patient(s): Thirty-three no
rmally ovulatory women with unexplained infertility. Intervention(s):
Eighteen women received CC at a 50-mg dosage. Fifteen women received n
o ovulation-induction drugs. Main Outcome Measures: The pregnancy rate
(PR) per patient, the PR per cycle, and the cumulative pregnancy rate
. Result(s): Seven patients in the CC group stopped taking CC, and obs
ervations were terminated because of antiestrogenic effects. The pregn
ancy rate (PR) per patient and the PR per cycle were significantly dec
reased (P <0.005) in the CC group (4 of 18 [22.2%] and 4 of 66 [6.1%],
respectively) than in the spontaneous group (11 of 15 [73.3%] and 11
of 52 [21.2%], respectively). Kaplan-Meier tests showed that the cumul
ative pregnancy rate in the CC group was significantly lower than in t
he spontaneous group (P <0.05). Five of seven patients who had stopped
taking CC became pregnant in spontaneous cycles. Conclusion(s): Admin
istration of CC to normally ovulatory women is not efficacious in term
s of increasing the pregnancy rate. (C) 1997 by American Society for R
eproductive Medicine.