Impact of Folates in the Care of the Male Infertility
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 162
- 试验地点
- 1
- 主要终点
- The rates of pregnancy in IVF +/- ICSI and spontaneous pregnancy according to the arm of treatment
研究概览
简要总结
Unexplained male infertility is increasing, and, nowadays, the investigators only can propose palliative treatment, as In VITRO Fertilization (IVF). The folate metabolism is a key for the maintenance of genome integrity. A dysfunction in this pathway can be responsible of spermatogenesis defects, and further, of infertility. Few assays have shown that folate treatment can improve sperm parameters and fertility, till 30% in some of theses studies. The purpose of the investigators study is to demonstrate the impact of folates treatment on improvement of sperm parameters and on the rate of success of in VITRO fertilization procedures.
详细描述
The folate impact in the treatment of male infertility will be reviewed by this large multicentric randomized controlled double-blind study comparing 2 parallel groups of 184 patients. In each group: folic acid 15mg/day versus placebo, orally for at least 3 months (duration of a cycle of spermatogenesis). This assay will evaluate the effectiveness of treatment with folic acid compared to its placebo in infertile men with the outcome of IVF+/-ICSI techniques (pregnancy rate). It will also assess the impact of folate therapy on sperm parameters, and further, the impact on abnormal sperm DNA methylation profiles.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Couple whose man is from 18 to 60 years old
- •Couple whose man presents an infertility indicating a care in VITRO fertilization with or without intracytoplasmic sperm injection (IVF +/- ICSI)
- •Couple whose spouse is from 18 to 38 years old
- •Couple whose spouse do not present particular factors of infertility
- •Couple Taken care in IVF +/- ICSI
- •Couple with social insurance
- •2 members of the couple having signed the consent
排除标准
- •Etiology of not genetic known male infertility : infertility of neoplastic origine, infertility of definitive obstructive origin
- •Presence of a factor of feminine infertility : A definitive infertility tubal, Turned out ovarian incapacity (FSH > 9 and/or CFA <= 8)
- •Male infertility requiring the appeal to some sperm testicular or in some frozen sperm- Men or women attend of HIV or hepatitis B or C
- •Epileptic men
- •Men under anti-folic treatment
- •Men presenting a big sensibility to the folic acid or to one of the constituents of the drug
- •Couple of which one of the partners refuses to participate in the study
研究组 & 干预措施
Folic acid
tablets of 5 mg of folic acid
干预措施: Folic acid (Drug)
Placebo
Tablets of placebo of folic acid
干预措施: placebo of folic acid (Drug)
结局指标
主要结局
The rates of pregnancy in IVF +/- ICSI and spontaneous pregnancy according to the arm of treatment
时间窗: 3 months
Estimate the efficiency of the treatment by folic acid at infertile men on the improvement of improvement of the pregnancy rates in IVF +/- ICSI and spontaneous pregnancy before IVF +/- ICSI
次要结局
- The rate of improvement of the sperm parameters with acid folic treatment(3 months)
- The rate of improvement of the nuclear quality of gametes with acid folic treatment(3 months)
- The rate of pregnancy of couple with infertile men treated by folic acid according to the methylene-tetrahydrofolate reductase (MTHFR) genotype(3 months)
- The difference between the methylene-tetrahydrofolate reductase (MTHFR) genotype of the patients on sperm parameters according to the arm of treatment(3 months)