IVF Outcomes With Time-Lapse Culture: Comparison Between PPOS and GnRH Antagonist Protocols
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 148
- 试验地点
- 1
- 主要终点
- Blastocyst formation rate
研究概览
简要总结
The goal of this clinical trial is to compare two ovarian stimulation protocols used in in vitro fertilization (IVF): the fixed Progestin-Primed Ovarian Stimulation (PPOS) protocol and the GnRH Antagonist protocol. The study will evaluate IVF outcomes and embryo development patterns using time-lapse embryo monitoring technology. The main questions the study aims to answer are:
- Does the fixed - PPOS protocol achieve similar numbers of mature eggs, good-quality embryos, and clinical outcomes compared to the GnRH Antagonist protocol?
- Are there differences in embryo development patterns (morphokinetics) between the two protocols when monitored by time-lapse imaging?
- How does embryo quality (KIDScore) compare between the two protocols?
Study Design:
Researchers will randomly assign 148 women undergoing IVF to two groups:
- PPOS group (n=74): Will receive FSH injections (oral Duphaston 20mg daily) starting from day 2-3 of the menstrual cycle
- GnRH Antagonist group (n=74): Will receive FSH injections (Orgalutran 0.25mg injections) when follicles reach ≥14mm
Participants will:
- Undergo controlled ovarian stimulation with their assigned protocol for approximately 10-12 days
- Have regular ultrasound monitoring and blood tests to track follicle development
- Undergo egg retrieval procedure when follicles are mature
- Have all embryos cultured in the EmbryoScope time-lapse incubator with continuous monitoring
- Have embryos frozen on Day 5/6 for future transfer
Study Location:
Department of Assisted Reproduction and Andrology, Hanoi Obstetrics and Gynecology Hospital
Study Duration: January 2026 - June 2028
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
- 20 Years 至 45 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Women aged 20-45 years
- •Indicated for in vitro fertilization (IVF) treatment
- •Planned freeze-all embryo strategy
- •Voluntary participation in research.
排除标准
- •Systemic diseases
- •Use of hormonal medications within 3 months prior to enrollment
- •Oocyte donation cycles
- •Unwilling or unable to participate in research
研究组 & 干预措施
PPOS protocol
FSH + Dydrogesterone 20mg/day from day 2 - 3 of the menstrual cycle. Optional LH supplementation. Freeze-all with time-lapse monitoring.
干预措施: Progestin-Primed Ovarian Stimulation (Drug)
Antagonist protocol
FSH + Orgalutran 0.25 mg/day (starting when follicle ≥12 mm). Optional LH supplementation. Freeze-all with time-lapse monitoring.
干预措施: Antagonist protocol for IVF (Drug)
结局指标
主要结局
Blastocyst formation rate
时间窗: Day 5 to Day 6 after oocyte retrieval
Number of high-quality blastocysts (grade ≥ 3BB) obtained per cycle
次要结局
- Embryo morphokinetic development(Day 2 to day 5 after oocyte retrieval)