Objective: To explore the effectiveness, safety and cost between urinary follicle stimulating hormone (uFSH) and recombinant follicle stimulating hormone (rFSH) in controlled ovarian stimulation (COS) in China. Methods: Data were collected from 16 reproductive centers in China covering oocytes collection time from May 1, 2015 to June 30, 2018. Eligible patients were over 18 years old, adopting COS with uFSH (uFSH group) or rFSH (rFSH group) as start gonadotropins (Gn), and using in vitro fertilization (IVF) and (or) intracytoplasmic sperm injection for fertilisation, excluding frozen embryo recovery cycle. Generalised estimating equation was used to address the violation of independency assumption between cycles due to multiple IVF cycles for one person and clustering nature of cycles carried out within one center. Controlling variables included age, body mass index, anti-Müllerian hormone level, cause of infertility, ovulation protocol, type of fertilisation, number of embryos transferred, number of days of Gn use. Results: Totally 102 061 cycles met eligibility criteria and were included in the analyses. In terms of effectiveness, after controlling relevant unbalanced baseline characteristics, compared with rFSH group, the high oocyte retrieval (>15 oocytes was considered high retrieval) rate of uFSH group significantly decreased in gonadotropin-releasing hormone agonist protocol (OR=0.642, P<0.01) and in gonadotropin-releasing hormone antagonist protocol (OR=0.556, P=0.001), but the clinical pregnancy rate per transfer cycle and the live birth rate per transfer cycle significantly increased (OR=1.179, OR=1.169, both P<0.01) in both agonist and antagonist protocols. For safety, multiple analysis result demonstrated that in the agonist protocol, compared with rFSH group, the incidence of moderate to severe ovarian hyperstimulation syndrome of uFSH group significantly decreased (OR=0.644, P=0.002). The differences in ectopic pregnancy rate and multiple pregnancy rate between the uFSH and rFSH groups were not significant (P=0.890, P=0.470) in all patients. In terms of cost, compared with rFSH group, the uFSH group had lower total Gn costs for each patient (P<0.01). Conclusion: For patients who underwent COS, uFSH has better safety, and economic profiles over rFSH in China.
目的： 探讨尿源性卵泡刺激素（uFSH）与重组卵泡刺激素（rFSH）在控制性促排卵中的有效性、安全性和费用差异。 方法： 本研究是一项回顾性队列研究。数据来自全国16家生殖中心，所收集周期的取卵时间为2015年5月1日至2018年6月30日，使用uFSH（uFSH组）或rFSH（rFSH组）作为起始促性腺激素（Gn）进行控制性促排卵，并使用体外受精（IVF）和（或）卵母细胞胞质内单精子注射进行受精的新鲜周期。由于同一患者可多次接受IVF周期治疗且在同一中心内进行的周期间不独立，故使用广义估计方程进行多因素分析，纳入调整的变量包括年龄、体质指数、抗苗勒管激素水平、不孕原因、促排卵方案、受精方式、移植胚胎数、Gn使用天数。 结果： 本研究共纳入102 061个新鲜周期进行分析。在有效性方面，当控制不平衡的基线特征后，与rFSH组相比，uFSH组的高获卵数（定义为获卵数>15个）率显著降低（促性腺激素释放激素激动剂方案：OR=0.642，P<0.01；促性腺激素释放激素拮抗剂方案：OR=0.556，P=0.001）。对比于rFSH组，无论激动剂方案还是拮抗剂方案，uFSH组每移植周期的临床妊娠率和每移植周期的活产率均显著增加（OR=1.179、1.169，P均<0.01）。在安全性方面，多因素分析结果显示，在激动剂方案中，与rFSH组相比，uFSH组中重度卵巢过度刺激综合征（OHSS）的发生率显著降低（OR=0.644，P=0.002）；在所有方案中，uFSH组与rFSH组的异位妊娠率和多胎妊娠率差异均不显著（P=0.890、0.470）。在费用方面，与rFSH组相比，uFSH组的人均Gn总花费降低（P<0.01），rFSH组的预计成本为6 734元，uFSH组为3 880元。 结论： 对于接受控制性促排卵的患者，uFSH相对于rFSH在安全性和经济性方面更有优势。.