Melatonin Supplementation in Ovarian Response: a Double-blind Randomized Controlled Trial on Follicular Fluid Melatonin Levels and Reproductive Outcomes in Infertile Women
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 80
- 试验地点
- 1
- 主要终点
- Follicular fluid melatonin concentration
研究概览
简要总结
Melatonin is a potent antioxidant, has been proposed to improve ovarian response and oocyte quality in assisted reproductive technologies (ART). This study evaluated the effects of melatonin supplementation on follicular fluid melatonin levels, hormonal profiles, and reproductive outcomes in women undergoing in vitro fertilization (IVF). Follicular fluid and serum melatonin levels, oocyte quality, embryo development, and pregnancy rates were assessed.
详细描述
Background: Melatonin, a potent antioxidant, has been proposed to improve ovarian response and oocyte quality in assisted reproductive technologies (ART). This study evaluated the effects of melatonin supplementation on follicular fluid melatonin levels, hormonal profiles, and reproductive outcomes in women undergoing in vitro fertilization (IVF).
Methods: In this double-blind, randomized controlled trial, 80 infertile women were allocated to receive either 5 mg melatonin nightly (n=40) or placebo (n=40) during ovarian stimulation. Follicular fluid and serum melatonin levels, oocyte quality, embryo development, and pregnancy rates were assessed. Statistical analyses included Mann-Whitney U tests for continuous variables and chi-square/Fisher's tests for categorical data.
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
- Quadruple (Participant, Care Provider, Investigator, 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
- •Infertile women aged 18-40 years
- •No previous infertility treatment
- •No previous hormonal treatment
- •No previous radio-chemotherapy treatment
排除标准
- •Fertile women
- •Previous hormonal treatment
- •Previous radio-chemotherapy treatment
研究组 & 干预措施
Control
干预措施: Sham (No Treatment) (Other)
Melatonin suplementation
干预措施: 5mg melatonin supplementation (Drug)
结局指标
主要结局
Follicular fluid melatonin concentration
时间窗: Baseline (pre-intervention), periprocedurally and in the end of treatment at 7 weeks
次要结局
- Reprodutive outcomes(From the enrollment to the end of treatment at 7 weeks)
研究者
Jose Maria Soares Junior
Head of Gynecology Department, Principal Investigator, Clinical Professor
University of Sao Paulo General Hospital