Conception rates in clomiphene citrate cycles with and without hormone supplementation: a pilot study

• Published in: Current medical research and opinion 2005-07, Vol.21 (7), p.1035-1040
• Main Authors: Elkind-Hirsch, Karen E., Darensbourg, Carmen, Creasy, George, Gipe, Dan
• Format: Article
• Language: English
• Subjects: Adult; Clomiphene - therapeutic use; Combined Modality Therapy; Estradiol - therapeutic use; Estrogen Antagonists - therapeutic use; Female; Fertility Agents, Female - therapeutic use; Fertilization - drug effects; Humans; Infertility, Female - drug therapy; Menstrual Cycle - drug effects; Ovulation Induction; Pilot Projects; Pregnancy; Progesterone - therapeutic use
• ISSN: 0300-7995; 1473-4877
• DOI: 10.1185/030079905X48429

ABSTRACT Objective: A trial was conducted to examine the effects of a timed sequence of hormone supplementation (HS) with oral estradiol (E2) and vaginal progesterone (P) following clomiphene citrate (CC) therapy to determine if this regimen can increase pregnancy rates in CC cycles. Methods: This study was a randomized, open-label study. Seventy-one oligo-ovulatory women were randomized into one of two groups; those who received CC plus HS ( n = 34) and those who received no HS ( n = 37). All subjects received 100 mg CC orally from cycle days 3 to 7. Subjects randomized to HS started oral E2 at a dose of 1.5 mg BID on cycle day 8. All subjects monitored urine luteinizing hormone (LH) levels starting on cycle day 10; additionally, intercourse was encouraged starting on cycle day 10. Subjects receiving HS discontinued E2 with LH surge and started using vaginal progesterone gel (Prochieve 8%*) daily for 2 weeks starting 3 days after LH surge. All subjects had a pregnancy test (Assure†) 2 weeks after LH surge. If pregnancy occurred, the subject continued using vaginal progesterone gel daily for an additional 10 weeks. *Prochieve 8% is a registered trade name of Columbia Laboratories, Inc.; Livingston, NJ, USA †Assure is a registered trade name of Conception Technologies; San Diego, CA, USA Results: Sixty-five (65) subjects (31 CC plus HS and 34 no HS) completed the study. Fifty of the 65 subjects (77%) (23 [74%] CC plus HS, 27 [79%] no HS) who completed the study ovulated. The mean (range) progesterone (P) concentration for these 50 subjects was 1662.6 (340 to 5690) ng/dL, and mean and median P levels were slightly higher, but not statistically significant, in the HS group compared with the no HS group. Pregnancy rates were clinically, but not statistically, different between the treatment groups. Of the 50 responders, 12% became pregnant (17% CC plus HS, 7% no HS). Conclusion: These findings show a potential supportive effect on pregnancy rates in the CC plus oral estradiol and vaginal progesterone gel group compared to CC alone that needs to be confirmed in a larger study.