Impact of Melatonin Adjuvant Therapy on IVF/ICSI Outcomes in Prospective Poor Responders: A Double-blind, Randomized, Placebo-controlled Trial
试验速览
- 阶段
- 2 期
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- Total number of retrieved mature oocytes
研究概览
简要总结
The purpose of this study is to investigate the impact of melatonin administration on in vitro fertilization (IVF/ICSI) outcomes namely the total number and quality of the oocytes and embryos in the prospective poor responders.
详细描述
The prospective poor responders have been associated with lower number and poorer oocyte quality. Melatonin is suggested to have antioxidative effects which may contribute to improving the IVF/ICSI outcomes in this group of patients who expected to have poor outcomes. However, the expected beneficial effects of melatonin have not yet been investigated. The purpose of this study is to investigate the impact of melatonin administration on IVF/ICSI outcomes namely the total number and quality of the oocytes and embryos in the prospective poor responders. A randomized, double-blinded, placebo-controlled study is used to investigate the impact of melatonin on the IVF/ICSI outcomes.
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
- Double (Participant, Care Provider)
入排标准
- 年龄范围
- 30 Years 至 42 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Prospective poor responder with AMH < 1 ng/ml and AFC < 8 (in both ovaries).
排除标准
- •Severe male factor infertility.
研究组 & 干预措施
Melatonin
Melatonin 6 mg tablet once daily.
干预措施: Melatonin (Drug)
Placebo
Placebo tablet once daily
干预措施: Placebo (Other)
结局指标
主要结局
Total number of retrieved mature oocytes
时间窗: On the day of oocyte retrieval procedure
次要结局
未报告次要终点
研究者
Osama Saber Thabet Abdalmageed
Lecturer of OBGYN, Women Health Hospital, Assiut Univerisity
Assiut University