Obstetrics and Gynecology Department, Zagazig University, Zagazig, Sharkia 44511, Egypt.
Obstetrics and Gynecology Department, Kasr Al Ainy School of Medicine, Cairo University, El Saraya St., Cairo 11562, Egypt.
Hum Reprod. 2018 Jun 1;33(6):1079-1086. doi: 10.1093/humrep/dey054.
In ICSI patients with high risk of ovarian hyperstimulation syndrome (OHSS), are antagonist cycles triggered by gonadotropin releasing hormone (GNRH) agonist with a specialized luteal support regimen associated with comparable ongoing pregnancy rate (OPR) and less OHSS than those triggered by hCG?
In antagonist ICSI cycles, GnRH agonist triggering with a specialized luteal support regimen is associated with comparable OPR to those triggered by hCG but may be less likely to be associated with OHSS.
In IVF/ICSI protocols, exogenous hCG was used for years as a substitute of the endogenous LH surge. However, because of its longer half life, hCG is associated with more risk of OHSS, especially in high risk women. For this reason, GnRH agonist triggering was introduced. There is, however, no consensus on the best protocol for luteal support on agonist triggered cycles.
STUDY DESIGN, SIZE, DURATION: Randomized controlled open label trial including 190 participants recruited from June 2015 to March 2016 in a private fertility center. Participants were divided into 2 equal groups; GnRH agonist trigger and hCG trigger. Randomization was done using identical sealed envelope technique.
PARTICIPANTS/MATERIALS, SETTING, METHODS: One hundred ninety women, predicted to have high response, were randomized on the day of final oocyte maturation into two equal groups: group (A), GnRH agonist trigger followed by specialized regimen (1500 IU hCG) at time of oocyte retrieval plus oral estradiol and intramuscular progesterone during luteal phase; and group (B), 5000 IU of hCG with luteal support (oral estradiol and vaginal progesterone).
The 2 groups were comparable in baseline characteristics. OPR per randomized patient was comparable in the 2 groups {49/95 (51.6%) in group A, and 50/95 (52.6%) in group B ((P = 0.88); RR = 0.980, 95% CI: 0.75-1.29)}. Considerable (moderate + severe) OHSS was higher in group B (13/95 [14%] versus 5/95 [5%] P = 0.047; uncorrected Chi-square test). Upon performing multivariate regression analysis for predicting OHSS, number of follicles ≥11 mm on trigger day was the only independent predictor (P = 0.0004).
LIMITATIONS, REASONS FOR CAUTION: Strict selection criteria limit generalization of results. The study was powered for pregnancy rate not OHSS, so that the strength of evidence on OHSS prediction is weak.
We recommend the use of GnRH agonist plus the specialized luteal phase support in high responders with high risk of OHSS undergoing IVF/ICSI cycles. This protocol achieved a similar ongoing pregnancy to hCG triggering and may be less likely to result in moderate to severe OHSS.
STUDY FUNDING/COMPETING INTEREST(S): None.
PACTR 201506001132105.
24/6/2015.
DATE OF FIRST PATIENT’S ENROLLMENT: 26/6/2015.
在卵巢过度刺激综合征（OHSS）风险较高的 ICSI 患者中，使用促性腺激素释放激素（GnRH）激动剂触发拮抗剂周期，并采用特殊黄体支持方案，与使用 hCG 触发相比，是否具有相似的持续妊娠率（OPR）和更少的 OHSS 风险？
在拮抗剂 ICSI 周期中，GnRH 激动剂触发并采用特殊黄体支持方案与使用 hCG 触发相比，具有相似的 OPR，但与 OHSS 的相关性可能较低。
在 IVF/ICSI 方案中，外源性 hCG 多年来一直被用作内源性 LH 激增的替代品。然而，由于其半衰期较长，hCG 与更高的 OHSS 风险相关，尤其是在高风险女性中。因此，引入了 GnRH 激动剂触发。然而，对于触发周期的黄体支持，目前尚无最佳方案的共识。
研究设计、大小、持续时间：这是一项随机对照开放标签试验，纳入了 2015 年 6 月至 2016 年 3 月在一家私人生育中心招募的 190 名参与者。参与者被随机分为两组；GnRH 激动剂触发组和 hCG 触发组。采用相同的密封信封技术进行随机分组。
参与者/材料、设置、方法：190 名预测有高反应的女性在最后一次卵母细胞成熟日被随机分为两组：A 组，GnRH 激动剂触发，随后在取卵时采用特殊方案（1500 IU hCG），同时在黄体期口服雌二醇和肌内注射孕酮；B 组，5000 IU hCG 加黄体支持（口服雌二醇和阴道孕酮）。
两组在基线特征方面具有可比性。每组随机患者的 OPR 相似{95 名患者中的 49 名（51.6%）在 A 组，95 名患者中的 50 名（52.6%）在 B 组（P=0.88）；RR=0.980，95%CI：0.75-1.29)}。B 组（13/95 [14%]）的严重（中度+重度）OHSS 发生率高于 A 组（5/95 [5%]，P=0.047；未校正卡方检验）。在对 OHSS 进行多变量回归分析时，触发日≥11mm 的卵泡数是唯一的独立预测因子（P=0.0004）。
局限性、谨慎的原因：严格的选择标准限制了结果的推广。该研究的目的是妊娠率而不是 OHSS 预测，因此，OHSS 预测的证据强度较弱。
我们建议在接受 IVF/ICSI 周期治疗的高反应、高 OHSS 风险的患者中使用 GnRH 激动剂加特殊黄体期支持。这种方案与 hCG 触发相比，实现了相似的持续妊娠率，并且可能不太容易导致中重度 OHSS。
研究资金/利益冲突：无。
PACTR 201506001132105。
2015 年 6 月 24 日。
2015 年 6 月 26 日。
