Diet and Its Relationship With Couple Infertility (ALIFERT)
|Study Design:||Observational Model: Case Control
Time Perspective: Cross-Sectional
|Official Title:||Impact of the Diet Fertility : A Case-control Multicentric Study|
- Evaluate the nutritional status of fertile and infertile couples (food questionnaire - biologic, anthropometric and clinical balance). [ Time Frame: 24 hours ] [ Designated as safety issue: No ]
- 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 ] [ Designated as safety issue: No ]
- Impact of lifestyle (alcohol and tabacco consumption, physical activity, anxiety and sleep) on diet and fertility [ Time Frame: 24 hours ] [ Designated as safety issue: No ]
- Impact of nutritional status on fertility and ART parameters [ Time Frame: 24 hours ] [ Designated as safety issue: No ]
- Fertility : time to pregnancy (TTP) [ Time Frame: in the 6 months ] [ Designated as safety issue: No ]
- Male infertility : quantitative or qualitative semen abnormalities [ Time Frame: in the 6 months ] [ Designated as safety issue: No ]
- Pregnancy and obstetrical pathologies, prematurity, twin birth, weight of the new-born in infertile couples [ Time Frame: in the 6 months ] [ Designated as safety issue: No ]
- ART parameters, if appropriate [ Time Frame: in the 6 months ] [ Designated as safety issue: No ]
Biospecimen Retention: Samples With DNA
|Study Start Date:||October 2009|
|Study Completion Date:||June 2015|
|Primary Completion Date:||October 2013 (Final data collection date for primary outcome measure)|
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01093378
|Laboratoire d'Histologie- Embryologie - Cytogénétique - CECOS|
|Bondy, France, 93143|
|Principal Investigator:||Rachel Levy, MD, PhD||Assistance Publique - Hôpitaux de Paris|