Impact of Folates in the Care of the Male Infertility (FOLFIV)

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.

Study Overview

Status

Completed

Conditions

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 Type

Interventional

Enrollment (Actual)

162

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

      • Paris, France, 75020
        • Service of gynaecology-obstetrics and medicine of the reproduction, Tenon Hospital - APHP

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 60 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Folic acid
tablets of 5 mg of folic acid
Taking of folic acid 15 mg per day by hanging oral route during 3 at 4 months
Placebo Comparator: Placebo
Tablets of placebo of folic acid
Taking of placebo of folic acid by hanging oral route during 3 at 4 months

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
The rates of pregnancy in IVF +/- ICSI and spontaneous pregnancy according to the arm of treatment
Time Frame: 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
3 months

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

  • Principal Investigator: Emmanuelle MATHIEU - D'ARGENT, MD, TENON Hospital - APHP

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

November 1, 2011

Primary Completion (Actual)

April 1, 2016

Study Completion (Actual)

April 1, 2016

Study Registration Dates

First Submitted

June 28, 2011

First Submitted That Met QC Criteria

August 1, 2011

First Posted (Estimate)

August 2, 2011

Study Record Updates

Last Update Posted (Estimate)

June 9, 2016

Last Update Submitted That Met QC Criteria

June 8, 2016

Last Verified

May 1, 2016

More Information

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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