Improving Oocyte Retrieval Using a Combined Therapy of Recombinant Follicle Stimulating Hormone (rFSH) and Inositol and Melatonin
试验速览
- 阶段
- 4 期
- 状态
- 撤回
- 发起方
- 试验地点
- 2
- 主要终点
- Live birth rate
研究概览
简要总结
An efficient protocol of ovarian stimulation is a key part of assisted reproductive technology. In order to obtain the highest oocyte retrieval with no adverse effects, numerous studies have evaluated the efficiency of the clinical approaches currently available.
Recent studies have shown that two natural compounds, such as inositol and melatonin, play an important role in oocyte maturation and quality. Therefore, the present study aims at investigating whether inositol and melatonin are able to improve the number of oocytes obtained after ovarian stimulation with Recombinant Follicle Stimulating Hormone (rFSH).
To this purpose, a randomized double-blind trial will be established where 150 healthy women in reproductive age undergoing to assistant reproductive technology (ART) because of male infertility will be divided in two groups. Group A will be treated with 225IU rFSH alone, group B will be treated with 225IU rFSH, 4g inositol and 3mg melatonin.
As primary outcome of the study, oocyte quality, total number of oocytes retrieved, clinical pregnancy rate and live birth rate will be evaluated in group A vs. group B.
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, Investigator)
入排标准
- 年龄范围
- 18 Years 至 39 Years(Adult)
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Female age 18-39 years
- •BMI 18-30 kg/m2,
- •Fewer than 3 prior oocyte retrievals,
- •No fertility Problems
排除标准
- 未提供
研究组 & 干预措施
Recombinant FSH
225IU rFSH
干预措施: Recombinant FSH (rFSH) (Drug)
Recombinant FSH Inositol Melatonin
225IU rFSH, 4g Inositol and 3mg Melatonin
干预措施: rFSH + Inositol + Melatonin (Dietary Supplement)
结局指标
主要结局
Live birth rate
时间窗: 10 months after embryo transfer
Total oocyte number
时间窗: 2 weeks after pharmacological treatment
Number of clinical pregnancies
时间窗: 6 weeks after embryo transfer
次要结局
未报告次要终点
