Infertility Unit, Fondazione IRCCS Cà Granda, Ospedale Maggiore Policlinico, Milan, Italy.
Reprod Biol Endocrinol. 2012 Dec 18;10:114. doi: 10.1186/1477-7827-10-114.
The aim of the present randomised controlled non-inferiority trial is to test whether in women with compromised ovarian reserve requiring in vitro fertilisation, a protocol of ovarian stimulation using exclusively clomiphene citrate performs similarly to a regimen with high doses of gonadotropins.
Women with day 3 serum FSH > 12 IU/ml on at least two occasions or previous poor response to hyper-stimulation were recruited at four Italian infertility units. Selected women were allocated to clomiphene citrate 150 mg/day from day 3 to day 7 of the cycle (n=145) or to a short protocol with GnRH agonist 0.1 mg and recombinant FSH 450 IU daily (n=146). They were randomised by means of a computer-generated list into two groups. The study was not blinded. The main outcome of the study was the delivery rate per started cycle.
The study was interrupted after the scheduled two years of recruitment before reaching the sample size. 148 women were allocated to clomiphene citrate and 156 to the short protocol with high doses of gonadotropins; 124 and 125 participants were analysed in the groups, respectively. Women allocated to high doses of gonadotropins retrieved more oocytes and had a higher probability to perform embryo-transfer. However, the chances of success were similar. The delivery rate per started cycle in women receiving clomiphene citrate and high-dose gonadotropins was 3% (n=5) and 5% (n=7), respectively (p=0.77). The mean estimated cost per delivery in the two groups was 81,294 and 113,107 Euros, respectively. No side-effects or adverse events were observed.
In women with compromised ovarian reserve selected for in vitro fertilisation, ovarian stimulation with clomiphene citrate or high-dose gonadotropins led to similar chances of pregnancy but the former is less expensive.
Trial registered on http://www.clinicaltrials.gov (NCT01389713).
本随机对照非劣效试验的目的是测试在卵巢储备功能受损需要体外受精的女性中，仅使用克罗米酚的卵巢刺激方案是否与高剂量促性腺激素方案具有相同的效果。
在意大利的四个不孕不育中心，招募血清 FSH 在至少两次检测中为 3 天> 12IU/ml 或既往超刺激反应不佳的女性。选择的女性被分配至克罗米酚 150mg/天，从周期第 3 天至第 7 天（n=145）或使用 GnRH 激动剂 0.1mg 和重组 FSH 450IU 每日（n=146）的短方案。她们通过计算机生成的列表随机分为两组。该研究未设盲。主要研究结果为每个起始周期的分娩率。
在计划的两年招募期结束之前，该研究在达到样本量之前就被中断。148 名女性被分配至克罗米酚组，156 名女性被分配至高剂量促性腺激素的短方案组；分别有 124 名和 125 名参与者被纳入这两组进行分析。接受高剂量促性腺激素的女性获得了更多的卵子，并且更有可能进行胚胎移植。然而，成功的机会相似。接受克罗米酚和高剂量促性腺激素治疗的女性的每个起始周期的分娩率分别为 3%（n=5）和 5%（n=7）（p=0.77）。两组的平均估计分娩费用分别为 81294 欧元和 113107 欧元。未观察到任何副作用或不良事件。
在卵巢储备功能受损选择进行体外受精的女性中，使用克罗米酚或高剂量促性腺激素进行卵巢刺激可获得相似的妊娠机会，但前者成本更低。
试验在 http://www.clinicaltrials.gov 上注册（NCT01389713）。
