Dankert T, Kremer J A M, Cohlen B J, Hamilton C J C M, Pasker-de Jong P C M, Straatman H, van Dop P A
Department of Obstetrics and Gynecology, Radbound University Nijmegen Medical Center, The Netherlands.
Hum Reprod. 2007 Mar;22(3):792-7. doi: 10.1093/humrep/del441. Epub 2006 Nov 16.
Controlled ovarian hyperstimulation with intrauterine insemination (IUI) is a widely accepted treatment for unexplained and male subfertility. No consensus exists about the drug of first choice to be used as hyperstimulation. This randomized multicentre trial using a parallel design compares the efficacy of clomiphene citrate (CC) with that of recombinant FSH (rFSH).
Couples with primary unexplained or male subfertility were randomized to receive CC or rFSH for ovarian hyperstimulation. The treatment was continued for up to four cycles unless pregnancy occurred. Cycles with more than three follicles were cancelled. Cumulative pregnancy rates and live birth rates were primary outcomes. Cancellation during treatment and multiple birth rates are secondary outcomes. Results were analysed following the intention-to-treat principle.
Seventy couples with male subfertility and 68 couples with unexplained subfertility were included. Seventy-one women received CC, and 67 received rFSH. Twenty-seven pregnancies were observed in the CC group (38%) and 23 in the rFSH group (34.3%) relative risk (RR) 1.11 [95% confidence interval (95% CI) 0.71-1.73]. The live birth rate was 28.2% (20/71) and 26.9% (18/67) for CC and rFSH, respectively, RR 1.05 (95% CI 0.61-1.80). Overall, the live birth rates per cycle were 10% for CC-stimulated and 8.7% for rFSH stimulated cycles. The total multiple pregnancy rate was 6.0%. Thirty-five cycles (8.6%) were cancelled because of four or more follicles (CC, n = 17; rFSH, n = 18).
In couples with primary unexplained or male subfertility participating in an IUI program, ovarian hyperstimulation can be achieved by CC or rFSH. No significant difference in live birth rates between CC and rFSH was observed. Being less expensive, CC seems the more cost-effective drug and therefore, can be offered as drug of first choice.
控制性卵巢过度刺激联合宫腔内人工授精（IUI）是一种被广泛接受的治疗不明原因不孕和男性不育的方法。对于用作过度刺激的首选药物尚无共识。这项采用平行设计的随机多中心试验比较了枸橼酸氯米芬（CC）与重组促卵泡素（rFSH）的疗效。
将原发性不明原因不孕或男性不育的夫妇随机分组，接受CC或rFSH进行卵巢过度刺激。治疗持续进行最多四个周期，除非怀孕。卵泡超过三个的周期取消。累积妊娠率和活产率是主要结局。治疗期间的取消率和多胎出生率是次要结局。按照意向性分析原则分析结果。
纳入了70对男性不育夫妇和68对不明原因不育夫妇。71名女性接受CC治疗，67名接受rFSH治疗。CC组观察到27例妊娠（38%），rFSH组23例（34.3%），相对危险度（RR）1.11 [95%置信区间（95%CI）0.71 - 1.73]。CC组和rFSH组的活产率分别为28.2%（20/71）和26.9%（18/67），RR 1.05（95%CI 0.61 - 1.80）。总体而言，CC刺激周期的每个周期活产率为10%，rFSH刺激周期为8.7%。总多胎妊娠率为6.0%。35个周期（8.6%）因四个或更多卵泡而取消（CC组，n = 17；rFSH组，n = 18）。
在参与IUI计划的原发性不明原因不孕或男性不育夫妇中，CC或rFSH均可实现卵巢过度刺激。CC和rFSH的活产率未观察到显著差异。由于成本较低，CC似乎是更具成本效益的药物，因此可作为首选药物。
