■本研究旨在确定GnRH拮抗剂原始参考产品Cetrotide®和通用Ferpront®之间的活产率是否相似,促性腺激素释放激素(GnRH)拮抗剂方案用于控制性卵巢刺激(COS)。
■这项回顾性队列研究调查了使用GnRH拮抗剂方案的COS周期。这项研究是在三级保健医院内的专业生殖医学中心进行的,从2019年10月到2021年10月。在这段时间内,总共924个周期使用GnRH拮抗剂的起源,四肽®(A组),而1984年的周期是使用通用的,Ferpront®(B组)。
■卵巢储备标志物,包括抗苗勒管激素,窦卵泡数,和基础卵泡刺激素,与B组相比,A组较低。进行倾向评分匹配(PSM)以平衡组间的这些标志物。PSM之后,基线临床特征相似,除了A组与B组的不育持续时间稍长(4.43±2.92年vs.4.14±2.84年,P=0.029)。B组比A组使用GnRH拮抗剂的持续时间稍长(6.02±1.41vs.5.71±1.48天,P<0.001)。与A组相比,B组的卵母细胞数量略低(14.17±7.30vs.14.96±7.75,P=0.024)。然而,在第3天发现的可用胚胎数量和优质胚胎数量相当.生殖结果,包括生化妊娠损失,临床妊娠,流产,和活产率,两组之间没有显着差异。多因素logistic回归分析显示,GnRH拮抗剂的类型并不独立影响卵母细胞的数量,有用的胚胎,优质的胚胎,中度至重度OHSS率,临床妊娠,流产,或活产率。
回顾性分析显示,当Cetrotide®和Ferpront®在使用GnRH拮抗剂方案进行第一个和第二个COS周期的女性中使用时,在生殖结局方面没有临床显着差异。
UNASSIGNED: This study aims to determine whether the live birth rates were similar between GnRH antagonist original reference product Cetrotide® and generic Ferpront®, in gonadotropin-releasing hormone (GnRH) antagonist protocol for controlled ovarian stimulation (COS).
UNASSIGNED: This retrospective cohort study investigates COS cycles utilizing GnRH antagonist protocols. The research was conducted at a specialized reproductive medicine center within a tertiary care hospital, spanning the period from October 2019 to October 2021. Within this timeframe, a total of 924 cycles were administered utilizing the GnRH antagonist originator, Cetrotide® (Group A), whereas 1984 cycles were undertaken using the generic, Ferpront® (Group B).
UNASSIGNED: Ovarian reserve markers, including anti-Mullerian hormone, antral follicle number, and basal follicular stimulating hormone, were lower in Group A compared to Group B. Propensity score matching (PSM) was performed to balance these markers between the groups. After PSM, baseline clinical features were similar, except for a slightly longer infertile duration in Group A versus Group B (4.43 ± 2.92 years vs. 4.14 ± 2.84 years, P = 0.029). The duration of GnRH antagonist usage was slightly longer in Group B than in Group A (6.02 ± 1.41 vs. 5.71 ± 1.48 days, P < 0.001). Group B had a slightly lower number of retrieved oocytes compared to Group A (14.17 ± 7.30 vs. 14.96 ± 7.75, P = 0.024). However, comparable numbers of usable embryos on day 3 and good-quality embryos were found between the groups. Reproductive outcomes, including biochemical pregnancy loss, clinical pregnancy, miscarriage, and live birth rate, did not differ significantly between the groups. Multivariate logistic regression analyses suggested that the type of GnRH antagonist did not independently impact the number of oocytes retrieved, usable embryos, good-quality embryos, moderate to severe OHSS rate, clinical pregnancy, miscarriage, or live birth rate.
UNASSIGNED: The retrospective analysis revealed no clinically significant differences in reproductive outcomes between Cetrotide® and Ferpront® when used in women undergoing their first and second COS cycles utilizing the GnRH antagonist protocol.