NCT07394530招募中不适用
A Comparative Study of In Vitro Fertilization Outcomes Between PPOS and Antagonist Protocols in Women With Polycystic Ovary Syndrome
Hanoi General Hospital (Vietnam)1 个研究点 分布在 1 个国家目标入组 400 人开始时间: 2026年1月20日最近更新:
干预措施
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 400
- 试验地点
- 1
- 主要终点
- Ongoing pregnancy rate at 12 weeks
研究概览
简要总结
This study aims to compare the outcomes of two ovarian stimulation protocols used in in vitro fertilization (IVF): the progestin-primed ovarian stimulation (PPOS) protocol and the GnRH antagonist protocol.
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
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 40 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Women aged 18-40 years
- •Diagnosed with polycystic ovary syndrome (PCOS) according to the modified Rotterdam criteria (2004) (≥2 of 3: oligo/anovulation, hyperandrogenism, or polycystic ovarian morphology on ultrasound)
- •Indicated for in vitro fertilization (IVF) due to PCOS alone or PCOS with other infertility factors (e.g., tubal factor, previous failed IUI)
- •Eligible for controlled ovarian stimulation for IVF
- •Husband/partner with normal sperm parameters or mild to moderate oligoasthenoteratozoospermia (OAT)
- •Willing and able to provide written informed consent and comply with study procedures.
排除标准
- •Uterine abnormalities that may impair implantation or pregnancy outcomes, including congenital uterine malformations, large fibroids distorting the uterine cavity, adenomyosis, or severe intrauterine pathology.
- •History of major ovarian or uterine surgery affecting ovarian reserve or uterine structure (e.g., ovarian cystectomy, endometriosis surgery, myomectomy, unilateral oophorectomy)
- •History of recurrent pregnancy loss (≥3 spontaneous miscarriages)
- •Known chromosomal abnormalities in either partner
- •Inability to adhere to study protocol or follow-up procedures
研究组 & 干预措施
PPOS Protocol
Experimental
Participants receive ovarian stimulation using the progestin-primed ovarian stimulation (PPOS) protocol for in vitro fertilization.
干预措施: Progestin-Primed Ovarian Stimulation (PPOS) (Drug)
GnRH Antagonist Protocol
Active Comparator
Participants receive ovarian stimulation using a GnRH antagonist protocol for in vitro fertilization.
干预措施: GnRH Antagonist Protocol (Drug)
结局指标
主要结局
Ongoing pregnancy rate at 12 weeks
时间窗: Up to 12 weeks after embryo transfer
Ongoing pregnancy defined as a viable intrauterine pregnancy with fetal cardiac activity confirmed by ultrasound at or beyond 12 weeks of gestation.
次要结局
- Number of Oocytes Retrieved(From ovarian stimulation start to oocyte retrieval (approximately 10-14 days))
- Number of Mature (MII) Oocytes(At the time of oocyte retrieval (approximately 10-14 days after stimulation start))
- Live birth rate(Up to delivery (approximately 9-12 months after embryo transfer))
- Clinical pregnancy rate(6-7 weeks after embryo transfer)
- Fertilization Rate(16-18 hours after oocyte insemination)
- Number of Usable Embryos(From fertilization to embryo assessment (approximately Day 3 to Day 5 after oocyte retrieval).)
研究者
Nguyen Duy Phuong
Medical Doctor
Hanoi Medical University
研究点 (1)
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