Department of Obstetrics and Gynecology, Center for Reproductive Medicine, Guangdong Provincial Key Laboratory of Major Obstetric Diseases, Guangdong Provincial Clinical Research Center for Obstetrics and Gynecology, Guangdong-Hong Kong-Macao Greater Bay Area Higher Education Joint Laboratory of Maternal-Fetal Medicine, The Third Affiliated Hospital of Guangzhou Medical University, Guangzhou, China.
Department of Clinical Laboratory Medicine, The Third Affiliated Hospital of Guangzhou Medical University, Guangzhou, China.
Front Endocrinol (Lausanne). 2024 Jun 14;15:1358278. doi: 10.3389/fendo.2024.1358278. eCollection 2024.
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).
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).
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, 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, 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, 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.
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.
本研究旨在比较 GnRH 拮抗剂原研参考品西曲瑞克（Cetrotide）和仿制药福瑞朋（Ferpront）在 GnRH 拮抗剂方案控制性卵巢刺激（COS）中的活产率是否相似。
本回顾性队列研究调查了 GnRH 拮抗剂方案的 COS 周期。该研究在一家三级保健医院的专门生殖医学中心进行，时间范围为 2019 年 10 月至 2021 年 10 月。在此期间，共有 924 个周期使用 GnRH 拮抗剂原研药西曲瑞克（A 组），1984 个周期使用仿制药福瑞朋（B 组）。
A 组的卵巢储备标志物，包括抗苗勒管激素、窦卵泡数和基础卵泡刺激素，均低于 B 组。为了平衡两组间的这些标志物，进行了倾向评分匹配（PSM）。PSM 后，两组的基线临床特征相似，但 A 组的不孕时间略长于 B 组（4.43±2.92 年比 4.14±2.84 年，0.029）。B 组 GnRH 拮抗剂的使用时间略长于 A 组（6.02±1.41 天比 5.71±1.48 天，0.001）。B 组获卵数略少于 A 组（14.17±7.30 个比 14.96±7.75 个，0.024）。然而，两组间第 3 天可用胚胎数和优质胚胎数相当。两组间生化妊娠丢失率、临床妊娠率、流产率和活产率无显著差异。多变量逻辑回归分析表明， GnRH 拮抗剂的类型不能独立影响获卵数、可用胚胎数、优质胚胎数、中重度 OHSS 发生率、临床妊娠率、流产率或活产率。
本回顾性分析显示，在 GnRH 拮抗剂方案中，对于首次和第二次 COS 周期的妇女，使用西曲瑞克和福瑞朋时，其生殖结局无临床显著差异。
