Pouly J L, Bassil S, Frydman R, Hédon B, Nicollet B, Prada Y, Antoine J M, Zambrano R, Donnez J
Département de Gynécologie Obstétrique et Reproduction, l'Hôtel Dieu, CHU 63003.
Contracept Fertil Sex. 1997 Jul-Aug;25(7-8):596-601.
Two progesterone presentations, a vaginal application of 90 mg progesterone per day (Crinone) or 300 mg progesterone orally administered (Utrogestan) were compared for luteal phase support of patients undergoing an in vitro fertilisation (IVF) procedure. 283 patients were randomly allocated to either treatment. The treatment started within 24 hours after the embryo transfer procedure and continued until day 30 in cases of implantation. Efficacy was assessed using the pregnancy and delivery rates. Safety was assessed through specific symptoms and usual safety monitoring. The pregnancy rate per transfer was not significantly different in the Crinone and Utrogestan groups at day 12 (Crinone: 35.3%, Utrogestan: 29.9%, p = 0.55), at day 30 (Crinone: 28.8%, Utrogestan: 25%, p = 0.61), at day 90 (Crinone: 25.9%, Utrogestan: 22.9%, p = 0.69). No difference in spontaneous abortion rates were seen thereafter. The delivery rate was not significantly different (proportion delivery per patients included, Crinone: 23.0%, Utrogestan: 22.2%, p = 1), as well as the ratio new-born per transferred embryo (Crinone: 11.7%; Utrogestan: 11.1%, p = 0.91). Safety parameters were similar in both groups except for drowsiness, which was more significantly frequent in the oral P group than in the Crinone group at all time points. No serious adverse events were recorded in this study. The fact that Crinone matches the efficacy of the larger doses of progesterone used orally reflects an advantage of the transvaginal route of administration which avoids metabolic inactivation of progesterone during its first liver pass.
比较了两种黄体酮制剂，即每天经阴道应用90毫克黄体酮（雪诺酮）或口服300毫克黄体酮（安琪坦）对接受体外受精（IVF）手术患者的黄体期支持作用。283例患者被随机分配至两种治疗组。治疗在胚胎移植手术后24小时内开始，若发生着床则持续至第30天。使用妊娠率和分娩率评估疗效。通过特定症状和常规安全监测评估安全性。在第12天（雪诺酮组：35.3%，安琪坦组：29.9%，p = 0.55）、第30天（雪诺酮组：28.8%，安琪坦组：25%，p = 0.61）、第90天（雪诺酮组：25.9%，安琪坦组：22.9%，p = 0.69），两组每次移植的妊娠率无显著差异。此后自然流产率也无差异。分娩率无显著差异（纳入患者的分娩比例，雪诺酮组：23.0%，安琪坦组：22.2%，p = 1），每个移植胚胎的新生儿比例也无差异（雪诺酮组：11.7%；安琪坦组：11.1%，p = 0.91）。除嗜睡外，两组的安全参数相似，在所有时间点，口服黄体酮组的嗜睡发生率均显著高于雪诺酮组。本研究未记录到严重不良事件。雪诺酮与大剂量口服黄体酮疗效相当，这一事实反映了经阴道给药途径的优势，即避免了黄体酮在首次肝循环中发生代谢失活。
