Effect of Estradiol Pretreatment on Follicular Synchronization and IVF Outcomes in Women With Polycystic Ovary Syndrome Undergoing ICSI Using GnRH Antagonist Protocol: A Randomized Clinical Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 61
- 试验地点
- 1
- 主要终点
- Follicular synchronization
研究概览
简要总结
This randomized clinical trial included 60 infertile women diagnosed with PCOS undergoing ICSI cycles using a GnRH antagonist protocol. Participants were randomly allocated into two equal groups: the pretreatment (Cyclo) group (n = 30), which received oral estradiol valerate (Cycloprogynova) 4 mg/day during the luteal phase before stimulation, and the control group (n = 30), which did not receive pretreatment.
Primary outcomes included follicular synchronization, total gonadotropin dose, duration of stimulation, and ovarian response. Secondary outcomes included mature oocyte yield, fertilization rate, embryo quality, and pregnancy outcomes.
详细描述
Controlled ovarian stimulation was initiated on day 2 of the menstrual cycle using individualized gonadotropin doses according to age, BMI, AMH, and AFC. GnRH antagonist was initiated once at least one follicle reached 13 mm diameter.
Ovulation trigger was administered when at least five follicles reached ≥17 mm. Add reference Oocyte retrieval was performed 36 hours after trigger under transvaginal ultrasound guidance.
Women in the pretreatment group received oral estradiol valerate (Cycloprogynova) 4 mg/day during the luteal phase from day 21 of prior cycle To day 2 of COH ovarian stimulation cycle while women in the control group underwent standard GnRH antagonist stimulation without estradiol pretreatment.
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 37 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •PCOS was defined by the presence of at least two of the following:
- •oligo or anovulation,
- •clinical or biochemical hyperandrogenism, and
- •polycystic ovarian morphology on ultrasound (≥12 antral follicles 2-9 mm in diameter and/or ovarian volume >10 mL).
- •All participants had undergone failed ovulation induction or were candidates for IVF/ICSI due to male factor infertility.
排除标准
- •previous ovarian surgery
- •endometriosis
- •known chromosomal abnormalities
- •untreated thyroid disease
- •body mass index (BMI) > 35 kg/m²
- •basal FSH >12 IU/L
- •use of hormonal medications within 3 months prior to the study.
结局指标
主要结局
Follicular synchronization
时间窗: at day 8 of stimulation
Mean follicle diameter and within patient standard deviation
次要结局
未报告次要终点
研究者
Ahmed M Maged, MD
Professor
Cairo University