Bhattacharya S, Harrild K, Mollison J, Wordsworth S, Tay C, Harrold A, McQueen D, Lyall H, Johnston L, Burrage J, Grossett S, Walton H, Lynch J, Johnstone A, Kini S, Raja A, Templeton A
Department of Obstetrics and Gynaecology, University of Aberdeen, Aberdeen AB25 2ZD.
BMJ. 2008 Aug 7;337:a716. doi: 10.1136/bmj.a716.
To compare the effectiveness of clomifene citrate and unstimulated intrauterine insemination with expectant management for the treatment of unexplained infertility.
Three arm parallel group, pragmatic randomised controlled trial.
Four teaching hospitals and a district general hospital in Scotland.
Couples with infertility for over two years, confirmed ovulation, patent fallopian tubes, and motile sperm.
Expectant management, oral clomifene citrate, and unstimulated intrauterine insemination.
The primary outcome was live birth. Secondary outcome measures included clinical pregnancy, multiple pregnancy, miscarriage, and acceptability.
580 women were randomised to expectant management (n=193), oral clomifene citrate (n=194), or unstimulated intrauterine insemination (n=193) for six months. The three randomised groups were comparable in terms of age, body mass index, duration of infertility, sperm concentration, and motility. Live birth rates were 32/193 (17%), 26/192 (14%), and 43/191 (23%), respectively. Compared with expectant management, the odds ratio for a live birth was 0.79 (95% confidence interval 0.45 to 1.38) after clomifene citrate and 1.46 (0.88 to 2.43) after unstimulated intrauterine insemination. More women randomised to clomifene citrate (159/170, 94%) and unstimulated intrauterine insemination (155/162, 96%) found the process of treatment acceptable than those randomised to expectant management (123/153, 80%) (P=0.001 and P<0.001, respectively).
In couples with unexplained infertility existing treatments such as empirical clomifene and unstimulated intrauterine insemination are unlikely to offer superior live birth rates compared with expectant management.
ISRCT No: 71762042.
比较枸橼酸氯米芬及未刺激的宫腔内人工授精与期待疗法治疗不明原因不孕症的有效性。
三臂平行组实用随机对照试验。
苏格兰的四家教学医院和一家地区综合医院。
不孕两年以上、排卵确认、输卵管通畅且精子活动的夫妇。
期待疗法、口服枸橼酸氯米芬及未刺激的宫腔内人工授精。
主要观察指标为活产。次要观察指标包括临床妊娠、多胎妊娠、流产及可接受性。
580名女性被随机分配至期待疗法组（n = 193）、口服枸橼酸氯米芬组（n = 194）或未刺激的宫腔内人工授精组（n = 193），为期6个月。三个随机分组在年龄、体重指数、不孕持续时间、精子浓度及活力方面具有可比性。活产率分别为32/193（17%）、26/192（14%）和43/191（23%）。与期待疗法相比，枸橼酸氯米芬治疗后活产的优势比为0.79（95%置信区间0.45至1.38），未刺激的宫腔内人工授精后为1.46（0.88至2.43）。随机分配至枸橼酸氯米芬组（159/170，94%）和未刺激的宫腔内人工授精组（155/162，96%）的女性比随机分配至期待疗法组（123/153，80%）的女性更能接受治疗过程（P分别为0.001和P<0.001）。
对于不明原因不孕症的夫妇，与期待疗法相比，经验性使用枸橼酸氯米芬及未刺激的宫腔内人工授精等现有治疗方法不太可能提供更高的活产率。
国际标准随机对照试验编号：71762042。
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