Role of Melatonin Supplementation in Follicular Fluid of in Vitro Fertilization (IVF) Patients With Polycystic Ovarian Syndrome
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 试验地点
- 1
- 主要终点
- embryo quality
研究概览
简要总结
To evaluate the effects of melatonin supplementation on the main in vitro fertilization (IVF) outcomes during ovarian stimulation in patients with Polycystic ovarian syndrome (PCOS).
详细描述
Polycystic ovarian syndrome (PCOS) is a common endocrine disorder that causes infertility due to anovulation in women of reproductive age. Anovulation and also decreased oocyte and embryo quality may be cause of infertility in women with PCOS. Furthermore, the reactive oxygen species (ROS) induce oxidative stress which may be responsible for poor oocyte quality. The ROS generation from mononuclear cells is elevated in women with PCOS and a significant increment of lipid peroxidation products in women with PCOS has been reported.
Melatonin is a documented powerful free radical scavenger and a broad spectrum antioxidant. It has been observed that a non-PCOS group co-treated with inositol, folic acid, and melatonin (Inofolic Plus by LO.LI.Pharma) results in a significantly greater mean number of mature oocytes, and a lower mean number of immature oocytes in patients with low oocyte quality history when compared to treatment only with inositol and folic acid (Inofolic by LO.LI.Pharma).
The aim of the study is to evaluate the possible effects of melatonin supplementation on the main IVF outcomes during ovarian stimulation of patients with PCOS.
From July 2009 to December 2011, 358 patients with PCOS (Rotterdam criteria) were enrolled in this prospective randomized controlled trial.
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- 27 Years 至 38 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •diagnosis of PCOS
- •irregular menstrual cycle (> than 28-30 days)
- •normal uterine cavity
- •body mass index of 20 to 26 Kg/m2
- •first IVF treatment
排除标准
- •presence of tubal, uterine, genetics and male causes of infertility
- •diagnosis of cancer
- •hormonal treatment in the last six months
研究组 & 干预措施
Inofolic plus
178 patients
干预措施: Myo-inositol + folic acid + melatonin (Dietary Supplement)
Inofolic
180 patients
干预措施: Myo-inositol + folic acid (Dietary Supplement)
结局指标
主要结局
embryo quality
Implantation rate
Pregnancy rate
Number of mature oocytes
次要结局
- Serum estradiol levels
- Total dose of FSH administered
- Cancellation rate
- Number of days of stimulation
- Endometrial thickness
- Incidence of moderate or severe ovaric hyperstimulation syndrome (OHSS)