Fernandez H, Cedrin-Durnerin I, Gallot V, Rongieres C, Watrelot A, Mayenga-Mankezi J-M, Arnoux A
Service de gynécologie obstétrique, hôpital Bicêtre, AP-HP, 78, rue du Général-Leclerc, 94270 Le Kremlin-Bicêtre, France; CESP-Inserm U1018, 82, rue du Général-Leclerc, 94276 Le Kremlin-Bicêtre, France; Université Paris-Sud, 63, rue Gabriel-Péri, 94270 Le Kremlin-Bicêtre, France.
Service de médecine de la reproduction, hôpital Jean-Verdier, AP-HP, avenue du 14-Juillet, 93140 Bondy, France.
J Gynecol Obstet Biol Reprod (Paris). 2015 Oct;44(8):692-8. doi: 10.1016/j.jgyn.2014.10.016. Epub 2015 Jan 21.
To evaluate pregnancy rates after randomized controlled trial (RCT) between ovarian drilling by fertiloscopy or ovarian hyperstimulation+insemination+metformine after clomifène citrate (cc) treatment fails.
Randomized controlled trial with 126 patients in each arm in 9 university centers. After 6-9 months of stimulation by cc, 2 groups were randomized: group 1, ovarian drilling with bipolar energy versus group 2: 3 months treatment by metformine followed by 3 hyperstimulation by FSH+insemination. The success rate was pregnancy rate above 12 weeks.
RCT was stopped after the screening of 40 patients. In spite of the low number of patients, the pregnancy rate is significantly higher in medical group 8/16 versus 3/18 (p=0.04).
The causes of fail of RCT were in relationship with difficulties of inclusion, with absence of final agreement by team included. Moreover, RCT between medical and surgical management is often root of difficulties for patients who decline surgical strategy. However, medical treatment appeared better than drilling in this RCT.
评估在枸橼酸氯米芬（cc）治疗失败后，经输卵管镜卵巢打孔术与卵巢过度刺激+人工授精+二甲双胍之间进行随机对照试验（RCT）后的妊娠率。
在9个大学中心进行随机对照试验，每组126例患者。经cc刺激6 - 9个月后，将2组患者随机分组：第1组，采用双极能量进行卵巢打孔术；第2组：先用3个月二甲双胍治疗，然后进行3次促卵泡生成素（FSH）刺激+人工授精。成功率为孕12周以上的妊娠率。
在筛查40例患者后，RCT停止。尽管患者数量较少，但药物治疗组的妊娠率显著高于手术组，分别为8/16和3/18（p = 0.04）。
RCT失败的原因与纳入困难有关，与纳入团队未达成最终共识有关。此外，对于拒绝手术策略的患者，药物治疗与手术治疗之间的RCT往往是困难的根源。然而，在该RCT中，药物治疗似乎比打孔术效果更好。
