Half-dose Versus Conventional-dose Cetrorelix in Antagonist ICSI Cycles: Prospective Comparative Cohort Study
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 160
- 主要终点
- Clinical Pregnancy Rate
研究概览
简要总结
This prospective cohort study aims to compare the effectiveness of half-dose (0.125 mg/day) versus conventional-dose (0.25 mg/day) cetrorelix in GnRH antagonist ICSI cycles regarding clinical pregnancy rate in women with BMI ≥25 kg/m².
详细描述
Cetrorelix is used as a GnRH antagonist to prevent premature LH surge during controlled ovarian stimulation for ICSI. This observational study will include women aged less than 35 years with normal ovarian reserve and BMI ≥25 kg/m² who received either half-dose or conventional-dose cetrorelix as part of routine care. Clinical pregnancy rate and secondary reproductive outcomes will be compared between the two groups.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
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
- •- Age less than 35 years
- •Normal ovarian responders (AMH ≥1.2 ng/mL and AFC 5-15)
- •Body mass index (BMI) ≥25 kg/m²
- •Written informed consent
排除标准
- •- Age greater than 35 years
- •Diminished ovarian reserve (AMH <1.2 ng/mL or AFC <5)
- •Congenital uterine anomalies or significant intrauterine pathology
- •Contraindications to ovarian stimulation or pregnancy
- •Refusal to participate
研究组 & 干预措施
Half-dose Cetrorelix 0.125 mg
Women who received cetrorelix 0.125 mg daily as part of routine GnRH antagonist protocol.
Conventional-dose Cetrorelix 0.25 mg
Women who received cetrorelix 0.25 mg daily as part of routine GnRH antagonist protocol.
结局指标
主要结局
Clinical Pregnancy Rate
时间窗: 6 weeks after embryo transfer
Proportion of women with intrauterine gestational sac with fetal heartbeat by ultrasound at 6 weeks gestation
次要结局
- Ongoing pregnancy rate(12 weeks after embryo transfer)
- Number of retrieved oocytes(Periprocedurally, at time of oocyte retrieval, during oocyte pickup procedure)
- Number of mature MII oocytes(Periprocedurally , at time of oocyte retrieval, Day 0, during oocyte pickup procedure)
- Fertilization rate(1 day after ICSI)
- Premature LH surge(Baseline (before hCG trigger))
研究者
Samar Ahmed Mohy Eldien
Resident Physician
Assiut University