Comparative evaluation of pregnancy outcome in gonadotrophin-clomiphene combination vs clomiphene alone in polycystic ovarian syndrome and unexplained infertility-A prospective clinical trial

Abstract

OBJECTIVES:A large prospective clinical trial was conducted to compare the efficacy of single dose uFSH and clomiphene citrate combination with clomiphene citrate alone for ovulation induction to improve the pregnancy rate.MATERIALS AND METHODS:The study was a randomized, prospective clinical trial. Totally, 1527 infertile women (4381 cycles) with polycystic ovarian syndrome (PCOS) (n=911/2573 cycles) and unexplained infertility (n=616/1808 cycles) were randomized into two groups. Group A received single dose of uFSH on D3 of menstrual cycle along with clomiphene. Group B received clomiphene only for ovulation induction. We compared the pregnancy rate and miscarriage rate between two groups.RESULTS:Group A had a pregnancy rate of 17% compared to 8.3% of Group B which was significantly higher (P=0.0001). The miscarriage rate was 11% in Group A and 10% in Group B which was not significant (P=0.99). Pregnancy rates in PCOS women were 22% in Group A and 9.3% in Group B which shows significantly higher pregnancy rate (P=0.0001) in anovulatory infertility. But in unexplained infertility, there was no significant difference in pregnancy rate between Group A (11%) and Group B(6.3%). Miscarriage rates were 8.8% and 9.5% in Group A and Group B, respectively, in PCOS women and 14% and 13% in women with unexplained infertility.CONCLUSION:Addition of single dose of uFSH improves pregnancy outcome particularly in anovulatory infertility (WHO II). Correction of unexplained infertility may need more than simple correction of possible subtle ovulatory effect.

A study for evaluation of two protocols comprising of clomiphene citrate, human menopausal gonadotropin with or without follicle stimulating hormone for ovulation induction in patients with infertility for intrauterine insemination

“…Mukherjee S et al, reported that group A (uFSH +CC) had PR of 11% compared to 6.3% of group B (CC alone) in couples with unexplained infertility. 19 Gupta K et al, in their study observed higher pregnancy rate of 20% in CC+HMG group as compared to pregnancy rate of 15% in letrozole group. 15 In a similar study to the present study Chung MT et al, reported pregnancy rate of 14.8% in group 1(150U rFSH+CC) as compared to 20.4% in group 2(100U rFSH +CC).…”

Efficacy of extended clomifene citrate regimen in comparison with gonadotropins in clomifene citrate-resistant women with polycystic ovary syndrome

“…The primary outcome measures in this trial were the biochemical and clinical pregnancy rates. On the basis of previous studies, 14 94 participants were required in each group to detect this difference with a 5% level of significance (α error=0.05) and 80% power (1−β=0.8).…”

Clomiphene citrate alternatives for the initial management of polycystic ovary syndrome: an evidence-based approach

“…The authors concluded that the addition of single dose of uFSH improves pregnancy outcome particularly in anovulatory infertility (WHO II) compared with CC alone. However, they admitted the need for more RCTs to conWrm the possibility of replacing CC as the Wrst-line therapy for PCOS with CC + uFSH [82].…”

“…A recent large prospective clinical trial was conducted to compare the eYcacy of single dose uFSH (75 IU) on day 3 of menstrual cycle along with CC versus CC alone as a Wrst-line treatment in 1,527 infertile women (4,381 cycles), including PCOS (n = 911; 2,573 cycles) and unexplained infertility (n = 616; 1,808 cycles) [82]. Pregnancy and miscarriage rates were compared between groups.…”