Diet and Its Relationship With Couple Infertility (ALIFERT)
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|ClinicalTrials.gov Identifier: NCT01093378|
Recruitment Status : Completed
First Posted : March 25, 2010
Last Update Posted : August 31, 2015
|Condition or disease|
Infertility affects about 15% of couples. Many factors relating to lifestyle and environment are likely to influence fertility. As an adapted nutrition could prevent 30% of cancers, diet could be essential, but largely neglected, in the prevention of infertility.
Some studies tried to explore the impact of diet on male or female fertility, but very few focused on both. The aim of our study is to assess the role of nutrition in both fertile and infertile couples, taking into account most of factors relating to lifestyle. Clinical, anthropometric (BMI, fat mass), biological markers (non specific - glycaemia, lipids, inflammation, electrolytes - and specific - vitamins E, A, C, D, B, including folates and MTHFR polymorphism) and semen analysis, will be combined with validated questionnaires (nutrition, drugs, alcohol, tobacco, physical activity, sleep and stress).
The statistical analysis of correlations between nutritional and clinical data will provide information concerning the impact of nutrition on fertility.
|Study Type :||Observational|
|Actual Enrollment :||400 participants|
|Observational Model:||Case Control|
|Official Title:||Impact of the Diet Fertility : A Case-control Multicentric Study|
|Study Start Date :||October 2009|
|Actual Primary Completion Date :||October 2013|
|Actual Study Completion Date :||June 2015|
- Evaluate the nutritional status of fertile and infertile couples (food questionnaire - biologic, anthropometric and clinical balance). [ Time Frame: 24 hours ]
- Impact of genetic polymorphism on clinical and biological phenotypes linked to food behaviour in infertility context (MTHFR polymorphism for folates metabolism) [ Time Frame: 12 months ]
- Impact of lifestyle (alcohol and tabacco consumption, physical activity, anxiety and sleep) on diet and fertility [ Time Frame: 24 hours ]
- Impact of nutritional status on fertility and ART parameters [ Time Frame: 24 hours ]
- Fertility : time to pregnancy (TTP) [ Time Frame: in the 6 months ]
- Male infertility : quantitative or qualitative semen abnormalities [ Time Frame: in the 6 months ]
- Pregnancy and obstetrical pathologies, prematurity, twin birth, weight of the new-born in infertile couples [ Time Frame: in the 6 months ]
- ART parameters, if appropriate [ Time Frame: in the 6 months ]
Biospecimen Retention: Samples With DNA
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): NCT01093378
|Laboratoire d'Histologie- Embryologie - Cytogénétique - CECOS|
|Bondy, France, 93143|
|Principal Investigator:||Rachel Levy, MD, PhD||Assistance Publique - Hôpitaux de Paris|