黄体酮阴道缓释凝胶在IVF/ICSI周期中作为黄体支持的初步应用

Progesterone Sustained-Released Vaginal Gel for Luteal Phase Support in In Vitro Fertilization/Intracytoplasmic Sperm Injection Cycles

目的:评价黄体酮阴道缓释凝胶(商品名:雪诺同8%)在中国女性体外受精(IVF)和卵细胞浆内单精子注射(ICSI)周期中作为黄体支持的有效性和安全性。方法:此研究为多中心、前瞻性、开放性研究。在12家医院生殖医学中心共894例患者入组,自取卵日开始使用黄体酮阴道缓释凝胶作为黄体支持,评价周期的临床妊娠率、着床率、生化妊娠率、持续妊娠率,并对基线数据与妊娠率的关系进行分析,同时评价黄体酮阴道缓释凝胶使用的安全性及患者满意度。结果:共885例患者完成胚胎移植,其中857例患者完成研究,周期临床妊娠率44.0%(389/885),生化妊娠率为49.3%(436/885),持续妊娠率36.6%(324/885),早期流产率4.4%(17/389),异位妊娠率0.6%(5/885),着床率27.2%(536/1971)。妊娠结果与基线因素的分析,妊娠组与未妊娠组的年龄(30.9±3.7岁vs31.7±3.9岁)和取卵日孕酮水平(3.2±1.9nmol/Lvs4.5±8.3nmol/L)比较,差异有高度统计学意义(P=0.003,P=0.000),而两组其他基线因素比较,差异均无统计学意义(P>0.05)。不良事件的发生率4.5%,患者对药物使用方法的总体满意度89.7%。结论:黄体酮阴道缓释凝胶在辅助生殖技术中作为黄体支持具有满意的疗效和安全性,相比于传统给药方式,患者更愿接受黄体酮凝胶阴道给药。

Objective：To evaluate the efficacy and safety of progesterone sustained-released vaginal gel （Crinone 8%） for luteal phase support in in vitro fertilization （IVF） and intracytoplamsic sperm injection （ICSI） cycles in China. Methods：894 patients underwent assisted reproductive technology in 12 Chinese Reproductive Medicine Centers from April 2010 to June 2011 were enrolled in this prospective, multi-centre and open study. Progesterone sustained-released vaginal gel was used for luteal phase support from oocyte pick-up （OPU） till pregnancy test,and progesterone administration was continued till 10 -12 gestation weeks for positive women. Efficacy outcomes, including clinical pregnancy rate, implantation rate, biochemical preg- nancy rate,ongoing pregnancy rate and miscarriage rate were recorded. Correlations between clinical preg- nancy outcomes and baseline characteristics （such as patient＇s age, BMI, infertility history, previous attempts ofIVF/ICSI ,serum estradiol and progesterone level on OPU day） were evaluated. Safety profile was assessed via unsolicited reports （adverse events）. And let the patients to complete satisfactory questionnaire. Results： 885 of the 894 enrolled cases got embryos transferred and 857 cases completed the study. Overall clinical pregnancy rate was 44. 0% （389/885）. Biochemical pregnancy rate was 49. 3% （436/885）. Ongoing preg- nancy rate was 36. 6% （324/885）. Miscarriage rate was 4. 4% （17/389）. Ectopic pregnancy rate was 0. 6% （5/885）. Implantation rate was 27. 2% （536/1971）. In correlation analysis between pregnancy outcomes and baseline characteristics,significant difference was found in the average age （30. 9 ± 3. 7 vs 31.7±3. 9,P= 0. 003）, and theserum progesterone level on OPU day between clinical pregnant group and non-pregnant group （3. 2 ±1.9 vs 4. 5 ± 8. 3 nmol/L, P = 0. 000）. Other baseline characteristics had no correlation with pregnant outcomes. Adverse events rate was 4. 5% ,and no SAE was observed. The overall satisfaction rate was 89. 7%. Conclusions .vaginal administration of progesterone sustained-released gel once per day has sat- isfactory efficacy and safety profile as luteal phase support in IVF/ICSI cycles in Chinese population.