评估用1,500IU的人绒毛膜促性腺激素(hCG)和450IU的卵泡刺激素(FSH)触发是否诱导卵母细胞能力低于体外受精(IVF)中使用的标准剂量的hCG触发。如果替代触发剂在促进卵母细胞能力方面至少有效80%,则将被认为是不劣质的。
随机化,双盲,非劣性对照试验。
学术不孕症实践。
纳入18-41岁接受IVF的女性,其窦状卵泡数≥8,体重指数≤30kg/m2,且无2个IVF周期病史因反应不佳而取消。由于卵巢过度刺激综合征的高风险,在触发当天血清雌二醇>5,000pg/mL的参与者被排除在外。
参与者被随机分配接受1,500IUhCG加450IUFSH的替代触发剂或标准触发剂量的hCG(5,000或10,000IU)用于最终卵母细胞成熟。
主要结果是总胜任比例,定义为从卵母细胞中取出2个原核的概率。如果相对风险(RR)的单侧95%置信区间(CI)不<0.8,则替代触发因素将被认为不劣于标准触发因素。次要结果包括卵母细胞恢复和成熟,卵胞浆内单精子注射受精,胚胎质量,怀孕率,以及血清和卵泡激素。次要结果使用双侧优势检验进行比较。结果通过意向治疗和符合方案进行分析。
从2015年5月至2018年6月,共有105名接受IVF的女性被随机分组。替代触发因素的主要结局概率为0.59,标准触发因素的主要结局概率为0.65。RR为0.91,单侧95%CI为0.83。证明了替代触发因素的非劣效性。替代触发组中所有新鲜转移的活出生率与标准触发是46.9vs.46.4%(RR,1.01;95%CI,0.62-1.62),分别。在替代触发组中,每位随机参与者的活产率为48.1%,而不是62.7%的标准触发器(RR,0.73;95%CI,0.48-1.11)。没有参与者检索失败。
与标准hCG触发剂量相比,用1,500IU的hCG加上450IU的FSH触发可促进非劣质的卵母细胞能力。
NCT02310919。
To assess if triggering with 1,500 IU of human chorionic gonadotropin (
hCG) with 450 IU of follicle-stimulating hormone (FSH) induces noninferior oocyte competence to a standard dose of
hCG trigger used in in vitro fertilization (IVF). The alternative trigger will be considered noninferior if it is at least 80% effective in promoting oocyte competence.
Randomized, double-blinded, controlled noninferiority
trial.
Academic infertility practice.
Women aged 18-41 undergoing IVF with antral follicle count ≥8, body mass index ≤30 kg/m2, and no history of ≥2 IVF cycles canceled for poor response were enrolled. Participants with a serum estradiol >5,000 pg/mL on the day of trigger were excluded because of high risk of ovarian hyperstimulation syndrome.
Participants were randomized to receive an alternative trigger of 1,500 IU of hCG plus 450 IU of FSH or a standard trigger dose of
hCG (5,000 or 10,000 IU) for final oocyte maturation.
The primary outcome was total competent proportion, defined as the probability of 2 pronuclei from an oocyte retrieved. The alternative trigger will be considered noninferior to the standard trigger if a 1-sided 95% confidence interval (CI) of the relative risk (RR) is not <0.8. Secondary outcomes included oocyte recovery and maturity, intracytoplasmic sperm injection fertilization, embryo quality, pregnancy rates, as well as serum and follicular hormones. Secondary outcomes were compared using a 2-sided superiority test. Outcomes were analyzed by intention-to-treat and per-protocol.
A total of 105 women undergoing IVF were randomized from May 2015 to June 2018. The probability of the primary outcome was 0.59 with the alternative trigger and 0.65 with the standard trigger, with a RR of 0.91 and a 1-sided 95% CI of 0.83. Noninferiority of the alternative trigger was demonstrated. Live birthrate from all fresh transfers in the alternative trigger group vs. standard trigger was 46.9 vs. 46.4% (RR, 1.01; 95% CI, 0.62-1.62), respectively. Live birthrate per randomized participant was 48.1% in the alternative trigger group vs. 62.7% with the standard trigger (RR, 0.73; 95% CI, 0.48-1.11). No participants had a failed retrieval.
Triggering with 1,500 IU of hCG plus 450 IU of FSH promoted noninferior oocyte competence compared to a standard
hCG trigger dose.
NCT02310919.