ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT01407432
Recruitment Status : Completed
First Posted : August 2, 2011
Last Update Posted : June 9, 2016
Sponsor:
Information provided by (Responsible Party):
Assistance Publique - Hôpitaux de Paris

June 28, 2011
August 2, 2011
June 9, 2016
November 2011
April 2016   (Final data collection date for primary outcome measure)
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
The rates of pregnancy in IVF 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
Complete list of historical versions of study NCT01407432 on ClinicalTrials.gov Archive Site
  • 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
  • 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
  • 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
  • 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
Same as current
Not Provided
Not Provided
 
Impact of Folates in the Care of the Male Infertility
Impact of Folates in the Care of the Male Infertility
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.
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.
Interventional
Phase 3
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Male Infertility
  • 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
  • Experimental: Folic acid
    tablets of 5 mg of folic acid
    Intervention: Drug: Folic acid
  • Placebo Comparator: Placebo
    Tablets of placebo of folic acid
    Intervention: Drug: placebo of folic acid

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
162
780
April 2016
April 2016   (Final data collection date for primary outcome measure)

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
Sexes Eligible for Study: All
18 Years to 60 Years   (Adult)
No
Contact information is only displayed when the study is recruiting subjects
France
 
 
NCT01407432
P 100108
No
Not Provided
Not Provided
Assistance Publique - Hôpitaux de Paris
Assistance Publique - Hôpitaux de Paris
Not Provided
Principal Investigator: Emmanuelle MATHIEU - D'ARGENT, MD TENON Hospital - APHP
Assistance Publique - Hôpitaux de Paris
May 2016

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP