Effects of Treatment With Resveratrol on Oocyte and Embryo Quality in Patients Undergoing Assisted Reproductive Techniques( ART)
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 100
- 试验地点
- 2
- 主要终点
- blastocysts
研究概览
简要总结
To evaluate the effects of a new nutraceutical formulation containing resveratrol (trademark GENANTE) on gamete quality in order to improve the reproductive process during ART.
详细描述
The purpose of the study is to evaluate the effect of a new nutraceutical formulation containing resveratrol (trademark Genante) on gamete quality in order to improve the reproductive protocols during Assisted reproductive technology (ART) protocols.
The study is a randomized, single blind, parallel, comparative, experimental study during the pre-treatment before in vitro fertilization-embryo transfer (IVF-ET). A total number of 100 patients will be enrolled: 50 patients with a pretreatment control group (control group) and 50 patients with experimental pretreatment study group (resveratrol group). Patients will be assigned to groups during the recruitment phase in a randomized manner. In the control group, the treatment will consist of taking 400 microg once a day of folic acid commonly suggested as part of clinical practice, while in the Resveratrol Group, patients will receive one tablet twice a day (two tablets/day) of Genante. It is specified that the pretreatment with Genante includes folic acid in accordance with the clinical practice, 400 total microg per day. Both treatments will last for 3 months before the IVF procedure.
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 (Care Provider, Investigator)
入排标准
- 年龄范围
- 18 Years 至 42 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Women with a diagnosis of infertility
- •BMI between 18 and 30 kg/m2,
- •regular uterine cavity
- •normal thyroid function
- •normal blood parameters
排除标准
- •primary or secondary ovarian failure
- •patients who adhered to Bologna Criteria (at least two of the following: advanced maternal age >40, less than 3 oocytes recovered in previous attempts, abnormal ovarian reserve test)
- •presence of ovaries inaccessible to the oocyte pick-up,
- •persistent ovarian cysts > 20 mm,
- •presence of sactosalpinx
- •heterologous fertilization, significant systemic disease or other situations unsuitable for ovarian stimulation
结局指标
主要结局
blastocysts
时间窗: 6 months
number of blastocysts
MII oocytes
时间窗: 6 months
percentage of metaphase II oocytes
embryos
时间窗: 6 months
number of embryos
gonadotropins days
时间窗: 6 months
duration of ovarian stimulation (days)
follicles
时间窗: 6 months
Number of follicles \>16 mm
gonadotropins IU
时间窗: 6 months
dosage of gonadotropins (total IU during ovarian stimulation)
oocytes
时间窗: 6 months
number of recovered oocytes
fertilization
时间窗: 6 months
fertilization rates
次要结局
- embryos number(18 months)
- pregnancy(18 months)
- implantation(18 months)
- live birth(18 months)
- miscarriage(18 months)
研究者
Sandro Gerli
Associate Professor of Obstetrics and Gynecology
University Of Perugia