Trial record 3 of 867 for:    Open Studies | "Vitamin B Complex"

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

This study is currently recruiting participants. (see Contacts and Locations)
Verified February 2014 by Assistance Publique - Hôpitaux de Paris
Sponsor:
Information provided by (Responsible Party):
Assistance Publique - Hôpitaux de Paris
ClinicalTrials.gov Identifier:
NCT01407432
First received: June 28, 2011
Last updated: February 26, 2014
Last verified: February 2014
  Purpose

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.


Condition Intervention Phase
Male Infertility
Drug: Folic acid
Drug: placebo of folic acid
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Impact of Folates in the Care of the Male Infertility

Resource links provided by NLM:


Further study details as provided by Assistance Publique - Hôpitaux de Paris:

Primary Outcome Measures:
  • The rates of pregnancy in IVF according to the arm of treatment [ Time Frame: 3 months ] [ Designated as safety issue: No ]
    Estimate the efficiency of the treatment by folic acid at infertile men on the improvement of improvement of the pregnancy rates in IVF


Secondary Outcome Measures:
  • The rate of improvement of the sperm parameters with acid folic treatment [ Time Frame: 3 months ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    Estimate the impact of methylene-tetrahydrofolate reductase (MTHFR) genotype of the patients on sperm parameters according to the arm of treatment


Estimated Enrollment: 368
Study Start Date: November 2011
Estimated Study Completion Date: March 2015
Estimated Primary Completion Date: December 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Folic acid
tablets of 5 mg of folic acid
Drug: Folic acid
Taking of folic acid 15 mg per day by hanging oral route during 3 at 4 months
Other Name: Folic acid
Placebo Comparator: Placebo
Tablets of placebo of folic acid
Drug: placebo of folic acid
Taking of placebo of folic acid by hanging oral route during 3 at 4 months
Other Name: placebo of folic acid

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 390 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.

  Eligibility

Ages Eligible for Study:   18 Years to 60 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  • 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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01407432

Contacts
Contact: Emmanuelle Mathieu-D'Argent, MD + 33 (0) 1 56 01 68 69 emmanuelle.mathieu@tnn.aphp.fr
Contact: Célia Ravel, MD + 33 (0) 1 56 01 78 01 celia.ravel@tnn.aphp.fr

Locations
France
Service of gynaecology-obstetrics and medicine of the reproduction, Tenon Hospital - APHP Recruiting
Paris, France, 75020
Contact: Emmanuelle Mathieu-D'Argent, MD    + 33 (0) 1 56 01 68 69    emmanuelle.mathieu@tnn.aphp.fr   
Contact: Célia Ravel, MD         
Principal Investigator: Emmanuelle Mathieu - d'Argent, MD         
Sponsors and Collaborators
Assistance Publique - Hôpitaux de Paris
Investigators
Principal Investigator: Emmanuelle MATHIEU - D'ARGENT, MD TENON Hospital - APHP
  More Information

Publications:

Responsible Party: Assistance Publique - Hôpitaux de Paris
ClinicalTrials.gov Identifier: NCT01407432     History of Changes
Other Study ID Numbers: P 100108
Study First Received: June 28, 2011
Last Updated: February 26, 2014
Health Authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)
France: The Commission nationale de l’informatique et des libertés

Keywords provided by Assistance Publique - Hôpitaux de Paris:
Male infertility
folic acid
in VITRO fertilization
sperm parameters
MTHFR genotype

Additional relevant MeSH terms:
Folic Acid
Vitamin B Complex
Infertility
Infertility, Male
Genital Diseases, Male
Genital Diseases, Female
Hematinics
Vitamins
Micronutrients
Growth Substances
Physiological Effects of Drugs
Pharmacologic Actions
Hematologic Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on July 26, 2014