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Impact of Folates in the Care of the Male Infertility

NCT01407432 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 162

Last updated 2016-06-09

No results posted yet for this study

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.

Conditions

  • Male Infertility

Interventions

DRUG

Folic acid

Taking of folic acid 15 mg per day by hanging oral route during 3 at 4 months

DRUG

placebo of folic acid

Taking of placebo of folic acid by hanging oral route during 3 at 4 months

Sponsors & Collaborators

  • Assistance Publique - Hôpitaux de Paris

    lead OTHER

Principal Investigators

  • Emmanuelle MATHIEU - D'ARGENT, MD · TENON Hospital - APHP

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
60 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2011-11-30
Primary Completion
2016-04-30
Completion
2016-04-30

Countries

  • France

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01407432 on ClinicalTrials.gov