Impact of Folates in the Care of the Male Infertility (FOLFIV)
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ClinicalTrials.gov Identifier: NCT01407432 |
Recruitment Status
:
Completed
First Posted
: August 2, 2011
Last Update Posted
: June 9, 2016
|
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Male Infertility | Drug: Folic acid Drug: placebo of folic acid | Phase 3 |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 162 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor) |
Primary Purpose: | Treatment |
Official Title: | Impact of Folates in the Care of the Male Infertility |
Study Start Date : | November 2011 |
Actual Primary Completion Date : | April 2016 |
Actual Study Completion Date : | April 2016 |

Arm | Intervention/treatment |
---|---|
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
|
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
|
- 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 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

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Ages Eligible for Study: | 18 Years to 60 Years (Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
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

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01407432
France | |
Service of gynaecology-obstetrics and medicine of the reproduction, Tenon Hospital - APHP | |
Paris, France, 75020 |
Principal Investigator: | Emmanuelle MATHIEU - D'ARGENT, MD | TENON Hospital - APHP |
Publications:
Responsible Party: | Assistance Publique - Hôpitaux de Paris |
ClinicalTrials.gov Identifier: | NCT01407432 History of Changes |
Other Study ID Numbers: |
P 100108 |
First Posted: | August 2, 2011 Key Record Dates |
Last Update Posted: | June 9, 2016 |
Last Verified: | May 2016 |
Keywords provided by Assistance Publique - Hôpitaux de Paris:
Male infertility folic acid in VITRO fertilization sperm parameters MTHFR genotype |
Additional relevant MeSH terms:
Infertility Infertility, Male Genital Diseases, Male Genital Diseases, Female Folic Acid Vitamin B Complex |
Hematinics Vitamins Micronutrients Growth Substances Physiological Effects of Drugs |