Effects of Resveratrol Supplementation on Oocyte Quality in Advanced Maternal Aged Women Undergoing in Vitro Fertilization.
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 88
- 主要终点
- Number of good-quality embryos
研究概览
简要总结
The goal of this randomized, double-blind, placebo-controlled clinical trial is to verify if 3-month oral supplementation with resveratrol can enhance the oocyte quality in advanced maternal age women undergoing in vitro fertilization (IVF).
Participants will take a daily capsule of resveratrol or placebo during the 3 months preceding their IVF treatment. They will then follow the same treatment protocol as non-participant patients.
详细描述
The study will be conducted in the Reproductive Medicine Unit of an Academic Hospital.
Eligible participants who meet the inclusion and exclusion criteria will be randomly assigned to one of the following groups:
- Resveratrol (study group) or
- Placebo (control group).
Supplementation
Women in the study group will take a daily capsule of 200 mg Polygonum cuspidatum (Solgar®, Dietimport, Lisboa, Portugal) yielding 100 mg/day resveratrol (trans-3,5,4'-trihydroxystilbene). Women from control group will take a daily capsule of 400 mcg folic acid (Solgar®, Dietimport, Lisboa, Portugal), a vitamin widely prescribed to women who intend to achieve pregnancy for prevention of neural tube defects). Participants will be instructed to take the capsules by morning, every day during the 3 months preceding their IVF treatment. Oral intake of resveratrol/placebo will be discontinued after oocyte retrieval due to the potential adverse effects of resveratrol on endometrial decidualization. Package of resveratrol and placebo will be identical. Compliance of the participant to the intervention will be measured using capsule count. Participants will be asked to keep their usual lifestyle including nutrition and physical activity level.
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)
盲法说明
Patients, physicians, and embryologists will be blinded to group assignments of the participants in the trial.
入排标准
- 年龄范围
- 35 Years 至 40 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Women with infertility undergoing IVF/ICSI
- •Ovarian stimulation with GnRH-antagonist protocol
- •Age 35-40 years old
排除标准
- •Severe male factor (oligospermia or azoospermia)
- •Low ovarian reserve (AMH < 1.
- •Poor response to ovarian stimulation (< 3 oocytes)
- •Polycystic ovarian syndrome (Rotterdam criteria)
- •Ovarian endometriosis (endometrioma > 30 mm)
- •Uterine anomalies (congenital or acquired)
- •Diabetes Mellitus
- •Concurrent use of any vitamin (except folic acid)
结局指标
主要结局
Number of good-quality embryos
时间窗: 4 months
Embryos available to transfer or cryopreservation.
次要结局
- Number of oocytes and mature oocytes(4 months)
- Fertilization rate(4 months)
- Biochemical pregnancy rate(up to 15 months)
- Cumulate live birth rate(up to 15 months)
- Clinical pregnancy rate per cycle(up to 15 months)
- Ongoing pregnancy rate(up to 15 months)
- Cleavage rate(4 months)
- Clinical pregnancy rate per embryo transfer(up to 15 months)