Impact of Folates in the Care of the Male Infertility

Phase 3

Completed

• Conditions: Male Infertility
• Interventions: Drug: placebo of folic acid; Drug: Folic acid

• Registration Number: NCT01407432
• Lead Sponsor: Assistance Publique - Hôpitaux de Paris

Brief Summary

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.

Detailed Description

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.

Study Timeline

• Study First Submitted: 2011-06-28
• Study First Submitted QC: 2011-08-01
• Study First Posted: 2011-08-02
• Study Start: 2011-11
• Primary Completion: 2016-04
• Study Completion: 2016-04
• Status Verified: 2016-05
• Last Update Submitted: 2016-06-08
• Last Update Posted: 2016-06-09

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 162

Inclusion Criteria

• 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

Exclusion Criteria

• 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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Placebo	placebo of folic acid	Tablets of placebo of folic acid
Folic acid	Folic acid	tablets of 5 mg of folic acid

Primary Outcome Measures

Name	Time	Method
The rates of pregnancy in IVF +/- ICSI and spontaneous pregnancy according to the arm of treatment	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

Secondary Outcome Measures

Name	Time	Method
The rate of improvement of the sperm parameters with acid folic treatment	3 months	Estimate the efficiency of the treatment by folic acid on the sperm parameters
The rate of improvement of the nuclear quality of gametes with acid folic treatment	3 months	Estimate the efficiency of the treatment by folic acid on the nuclear quality of gametes
The rate of pregnancy of couple with infertile men treated by folic acid according to the methylene-tetrahydrofolate reductase (MTHFR) genotype	3 months	Estimate the impact of the methylene-tetrahydrofolate reductase (MTHFR) genotype of the patients on the rates of pregnancy according to the arm of treatment
The difference between the methylene-tetrahydrofolate reductase (MTHFR) genotype of the patients on sperm parameters according to the arm of treatment	3 months	Estimate the impact of methylene-tetrahydrofolate reductase (MTHFR) genotype of the patients on sperm parameters according to the arm of treatment

Trial Locations

Locations (1)

Service of gynaecology-obstetrics and medicine of the reproduction, Tenon Hospital - APHP; 🇫🇷 Paris, France