Conception rates in clomiphene citrate cycles with and without hormone supplementation: a pilot study.
OBJECTIVE
A trial was conducted to examine the effects of a timed sequence of hormone supplementation (HS) with oral estradiol (E(2)) 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 E(2) 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 E(2) 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.


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).


CONCLUSIONS
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.
Elkind-Hirsch
Karen E
KE
Woman's Health Research Institute, Baton Rouge, LA 70815, USA. Karen.Elkind-Hirsch@womans.org
Darensbourg
Carmen
C
Creasy
George
G
Gipe
Dan
D
D000328:Adult; D002996:Clomiphene / Q000627:therapeutic use*; D003131:Combined Modality Therapy; D004958:Estradiol / Q000627:therapeutic use; D004965:Estrogen Antagonists / Q000627:therapeutic use*; D005260:Female; D005300:Fertility Agents, Female / Q000627:therapeutic use*; D005306:Fertilization / Q000187:drug effects; D006801:Humans; D007247:Infertility, Female / Q000188:drug therapy*; D008597:Menstrual Cycle / Q000187:drug effects; D010062:Ovulation Induction; D010865:Pilot Projects; D011247:Pregnancy; D011374:Progesterone / Q000627:therapeutic use
D004965:Estrogen Antagonists; D005300:Fertility Agents, Female; D002996:Clomiphene; D011374:Progesterone; D004958:Estradiol