Hanaoka Masachi, Hanaoka Kanako, Yamada Mayu
Department of Reproductive Medicine, Hanaoka In Vitro Fertilization (IVF) Clinic Shinagawa, Tokyo, JPN.
Cureus. 2025 Jun 4;17(6):e85341. doi: 10.7759/cureus.85341. eCollection 2025 Jun.
This study aimed to examine the effects on oocyte retrieval, culture results, and pregnancy rates in Japanese women who underwent ovarian stimulation for assisted reproductive technology using two different protocols with follitropin delta. Specifically, it compared ovarian responses between a gonadotropin-releasing hormone (GnRH) antagonist protocol, used as a conventional controlled ovarian stimulation method, and a progesterone-primed ovarian stimulation (PPOS) protocol, considered a relatively new method.
This retrospective, observational study was conducted at a single in vitro fertilization clinic in Tokyo, Japan, from April 2022 to March 2024. The study population included infertile patients who were scheduled for treatment and met the inclusion criteria. Eligible participants were Japanese women aged 20-45 years with preserved ovarian function, indicated by an anti-Müllerian hormone level of ≥0.8 ng/mL. Exclusion criteria included contraindications for follitropin delta, previous oocyte stimulation for egg donation or fertility preservation, follicle-stimulating hormone levels ≥35 mIU/mL, uncontrolled malignant disease, stage III/IV endometriosis, and the use of hormone preparations (excluding thyroid medication) during the last menstrual cycle prior to study entry. The primary endpoint was the pregnancy rate per transfer in GnRH antagonist and PPOS cycles. Secondary endpoints included the number of oocytes retrieved and the blastocyst formation rate. Ongoing pregnancy was defined as a pregnancy in which a fetal heart rate was confirmed by 10 weeks of gestation. Accumulated data from GnRH antagonist cycles and PPOS cycles at the institution were combined to compare oocyte retrieval outcomes and pregnancy rates per transfer. Additionally, a stratified analysis by age (<35, 35-39, and ≥40 years) was performed.
Accumulated data included 149 GnRH antagonist cycles and 147 PPOS cycles. Oocyte retrieval outcomes and pregnancy rates per transfer were compared between the two protocols. There was no significant difference in the number of oocytes retrieved. However, the number of blastocysts showed a higher trend in the PPOS group compared to the GnRH antagonist group (p = 0.065). Across all age groups, the PPOS cycle tended to yield higher numbers of retrieved oocytes and blastocysts. Nonetheless, no significant difference was observed in the pregnancy rate per transfer between the two protocols.
Both the GnRH antagonist and PPOS protocols demonstrated trends toward higher numbers of retrieved oocytes and blastocysts, with comparable pregnancy rates across all age groups, suggesting similar clinical outcomes. A key limitation of this study is its retrospective design at a single institution; therefore, future prospective, large-scale studies are warranted.
本研究旨在探讨使用两种不同方案的促卵泡素δ对接受辅助生殖技术卵巢刺激的日本女性的取卵、培养结果和妊娠率的影响。具体而言，它比较了作为传统控制性卵巢刺激方法的促性腺激素释放激素（GnRH）拮抗剂方案与被认为是相对较新方法的孕激素预处理卵巢刺激（PPOS）方案之间的卵巢反应。
本回顾性观察研究于2022年4月至2024年3月在日本东京的一家体外受精诊所进行。研究人群包括计划接受治疗并符合纳入标准的不孕患者。符合条件的参与者为年龄在20 - 45岁之间、卵巢功能正常的日本女性，抗苗勒管激素水平≥0.8 ng/mL表明卵巢功能正常。排除标准包括促卵泡素δ的禁忌症、既往因卵子捐赠或生育力保存进行的卵母细胞刺激、促卵泡激素水平≥35 mIU/mL、未控制的恶性疾病、III/IV期子宫内膜异位症以及在研究入组前的最后一个月经周期使用激素制剂（不包括甲状腺药物）。主要终点是GnRH拮抗剂周期和PPOS周期每次移植的妊娠率。次要终点包括取卵数量和囊胚形成率。持续妊娠定义为妊娠10周时确认有胎心的妊娠。将该机构GnRH拮抗剂周期和PPOS周期的累积数据合并，以比较取卵结果和每次移植的妊娠率。此外，还按年龄（<35岁、35 - 39岁和≥40岁）进行了分层分析。
累积数据包括149个GnRH拮抗剂周期和147个PPOS周期。比较了两种方案之间的取卵结果和每次移植的妊娠率。取卵数量没有显著差异。然而与GnRH拮抗剂组相比，PPOS组的囊胚数量有更高的趋势（p = 0.065）。在所有年龄组中，PPOS周期往往能获得更多的取卵数和囊胚数。尽管如此，两种方案每次移植的妊娠率没有观察到显著差异。
GnRH拮抗剂方案和PPOS方案均显示出取卵数和囊胚数增加的趋势，所有年龄组的妊娠率相当，表明临床结果相似。本研究的一个关键局限性是其在单一机构的回顾性设计；因此，未来有必要进行前瞻性、大规模研究。
