Department of Endocrinology and Female Infertility, Reproductive Biomedicine Research Center, Royan Institute for reproductive biomedicine, ACECR, P.O Box: 19395-4644, No 12, East Hafez Avenue, Banihashem Street, Resalat highway, Tehran, Iran.
Department of Epidemiology and Reproductive Health, Reproductive Epidemiology Research Center, Royan Institute for Reproductive Biomedicine, ACECR, Tehran, Iran.
Reprod Biol Endocrinol. 2018 Dec 28;16(1):124. doi: 10.1186/s12958-018-0442-y.
Recently, a novel approach with delaying the start of controlled ovarian stimulation along with gonadotropin-releasing hormone (GnRH) antagonist pretreatment for 7 days after estrogen priming for further suppression of endogenous follicle stimulating hormone (FSH) during the early follicular phase, resulting in more FSH-responsive follicles and thus improving synchronous follicular development was introduced. Two clinical trials have examined this strategy and reported controversial results. This study aimed to compare the effect of delayed-start GnRH antagonist protocol and standard GnRH antagonist in patients with poor ovarian response (POR) undergoing in vitro fertilization (IVF)/ intracytoplasmic sperm injection (ICSI).
This randomized clinical trial was conducted at infertility department of Royan Institute from January 2017 to June 2018. Poor ovarian response was defined according to the Bologna criteria. The eligible women were randomly allocated into an experimental and control groups. In experimental group, patients received delayed-start GnRH antagonist protocol with estrogen priming followed by early follicular-phase GnRH antagonist treatment for 7 days before ovarian stimulation with gonadotropin and in control group, patients treated with estrogen priming antagonist protocol. IVF/ICSI outcomes were compared between groups.
Among all the 250 patients examined 156 women were eligible for study and finally 120 patients were allocated to intervention (n = 60) and control (n = 60) groups. Demographic characteristics and hormonal profiles of the patients did not differ between groups. The statistical analysis showed that there were significant differences between groups regarding the total dose of used gonadotropins (P < 0.001), stimulation duration (P < 0.001), number of retrieved oocytes (P = 0.01) and top quality embryo (P < 0.001) and also cancellation (P = 0.002) and fertilization rates (P = 0.002).
On the basis of present results the delayed-start protocol in poor responders can improve the fertilization rate and quality of embryos and reduce the cycle cancellation but have no significant effect on clinical pregnancy rate; however, larger randomized clinical trials are required to compare it with other protocols.
NCT, NCT03134690. Registered 1 May 2017 - Retrospectively registered, http://www.clinicaltrial.gov / NCT03134690.
最近，一种新的方法被提出，即在雌激素预处理后延迟开始控制性卵巢刺激，并在早期卵泡期用促性腺激素释放激素（GnRH）拮抗剂预处理 7 天，进一步抑制内源性卵泡刺激素（FSH），从而在早期卵泡期产生更多对 FSH 有反应的卵泡，从而改善同步卵泡发育。两项临床试验已经检验了这一策略，并报告了有争议的结果。本研究旨在比较延迟开始 GnRH 拮抗剂方案与标准 GnRH 拮抗剂在接受体外受精（IVF）/卵胞浆内单精子注射（ICSI）的卵巢反应不良（POR）患者中的效果。
这项随机临床试验于 2017 年 1 月至 2018 年 6 月在罗扬研究所的不孕不育科进行。卵巢反应不良根据博洛尼亚标准定义。合格的女性被随机分配到实验组和对照组。在实验组中，患者在接受雌激素预处理后，接受延迟开始的 GnRH 拮抗剂方案，然后在卵巢刺激用促性腺激素前，在早期卵泡期接受 GnRH 拮抗剂治疗 7 天，而在对照组中，患者接受雌激素预处理拮抗剂方案。比较两组之间的 IVF/ICSI 结果。
在所有 250 名接受检查的患者中，有 156 名女性符合研究条件，最终有 120 名患者被分配到干预组（n=60）和对照组（n=60）。两组患者的人口统计学特征和激素谱无差异。统计分析显示，两组在使用的促性腺激素总量（P<0.001）、刺激持续时间（P<0.001）、获卵数（P=0.01）和优质胚胎数（P<0.001）以及取消率（P=0.002）和受精率（P=0.002）方面存在显著差异。
基于目前的结果，延迟开始方案在卵巢反应不良的患者中可以提高受精率和胚胎质量，降低周期取消率，但对临床妊娠率没有显著影响；然而，需要更大规模的随机临床试验来将其与其他方案进行比较。
NCT，NCT03134690。于 2017 年 5 月 1 日注册-回顾性注册，http://www.clinicaltrial.gov/NCT03134690。
