A Randomized Controlled Trial Comparing 225 IU Versus 300 IU Starting Doses of Follicle-Stimulating Hormone in Progestin-Primed Ovarian Stimulation for Women With Good Prognosis
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 380
- 试验地点
- 1
- 主要终点
- Blastulation rate
研究概览
简要总结
This randomized controlled trial will compare two starting doses of follicle-stimulating hormone (FSH), 225 IU and 300 IU, during progestin-primed ovarian stimulation (PPOS) in women undergoing in vitro fertilization (IVF) who have a good reproductive prognosis. Participants will be randomly assigned to receive either 225 IU or 300 IU of FSH at the start of ovarian stimulation. The study will evaluate whether the starting FSH dose affects oocyte and embryo outcomes, with blastocyst formation as the primary outcome. Other outcomes will include oocyte morphology, fertilization, embryo development, and embryo quality. The findings may help determine an appropriate starting FSH dose for women with a good prognosis undergoing IVF using the PPOS protocol.
详细描述
This study is designed to evaluate whether the starting dose of follicle-stimulating hormone (FSH) affects oocyte and embryo outcomes in women with a good prognosis undergoing in vitro fertilization (IVF) using a progestin-primed ovarian stimulation (PPOS) protocol.
The optimal gonadotropin dose for women with a good prognosis remains uncertain. Although higher FSH doses may increase ovarian stimulation intensity, greater gonadotropin exposure may not necessarily improve oocyte or embryo outcomes. Conversely, a lower starting dose may provide adequate ovarian stimulation while reducing medication exposure. Therefore, this study will compare two starting FSH doses, 225 IU and 300 IU, in women with a good reproductive prognosis.
Eligible participants will be randomly assigned to receive either 225 IU or 300 IU of FSH as the starting dose during PPOS. The study will assess whether the starting FSH dose is associated with differences in oocyte characteristics, fertilization, embryo development, and blastocyst formation. The primary outcome is blastocyst formation rate. Secondary outcomes will include oocyte morphology, fertilization rate, cleavage-stage embryo development and quality, and blastocyst quality and usability.
Participants will also be followed through the first frozen embryo transfer cycle using embryos generated during the study cycle. Outcomes of the first frozen embryo transfer cycle will be assessed as prespecified secondary outcomes.
The results of this study may provide evidence to guide the selection of an appropriate starting FSH dose for women with a good prognosis undergoing IVF with PPOS.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 34 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Female patient or oocyte donor aged <35 years.
- •Body mass index (BMI) between 18 and 25 kg/m².
- •Normal ovarian reserve, defined by:
- •Antral follicle count (AFC) ≥8 on ultrasound; and
- •AMH level between 1.5 and 4.5 ng/mL.
- •First IVF treatment cycle.
- •Controlled ovarian stimulation using a progestin-primed ovarian stimulation (PPOS) protocol with recombinant FSH and dydrogesterone.
- •Indication for in vitro fertilization using intracytoplasmic sperm injection (ICSI).
- •Indication for extended embryo culture to the blastocyst stage.
- •Willingness to participate in the study and provision of written informed consent.
排除标准
- •Polycystic ovary syndrome (PCOS) diagnosed according to the Rotterdam criteria, currently referred to as polyendocrine metabolic ovarian syndrome (PMOS).
- •Structural abnormalities of the ovaries.
- •Ovarian endometriosis.
- •Medical or gynecological conditions that may affect ovarian response to controlled ovarian stimulation.
- •Indication for luteinizing hormone (LH) supplementation during controlled ovarian stimulation.
- •Poor sperm quality, cryptozoospermia, surgically retrieved sperm (PESA, TESE, or microTESE), cryopreserved sperm, or donor sperm.
- •Indication for artificial oocyte activation (AOA) or rescue ICSI (R-ICSI).
结局指标
主要结局
Blastulation rate
时间窗: From ICSI to Day 6 of embryo culture
The proportion of blastocysts formed among all mature (MII) oocytes subjected to intracytoplasmic sperm injection (ICSI), calculated as the total number of blastocysts divided by the total number of MII oocytes subjected to ICSI, multiplied by 100.
次要结局
- Oocyte morphology abnormality rate(At the time of oocyte denudation, prior to ICSI)
- Fertilization rate(Approximately 16-18 hours after ICSI)
- Cleavage embryo formation rate(Approximately 68-72 hours after ICSI)
- Good-quality cleavage-stage embryo rate(Approximately 68-72 hours after ICSI)
- Good-quality blastocyst rate(From Day 5 to Day 6 after ICSI)
- Usable blastocyst rate(From Day 5 to Day 6 after ICSI)
- Biochemical pregnancy rate(Approximately 14 days after frozen embryo transfer)
- Clinical pregnancy rate(Approximately 5-7 weeks after frozen embryo transfer)
- Ongoing pregnancy rate(Approximately 12 weeks after frozen embryo transfer)
研究者
Vo Nhu Thanh Truc
Head of IVF laboratory
Vietnam Military Medical University