Diet and Its Relationship With Couple Infertility (ALIFERT)

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborators:
Institut National de la Santé Et de la Recherche Médicale, France
University Paris 7 - Denis Diderot
Information provided by (Responsible Party):
Assistance Publique - Hôpitaux de Paris
ClinicalTrials.gov Identifier:
NCT01093378
First received: February 26, 2010
Last updated: August 25, 2014
Last verified: August 2014
  Purpose

This case-control multicentric study involving fertile and infertile couples aims at evaluating the impact on conception rate of nutritional parameters (biologic, clinic, anthropometric, and food questionnaire).


Condition
Infertility

Study Type: Observational
Study Design: Observational Model: Case Control
Time Perspective: Cross-Sectional
Official Title: Impact of the Diet Fertility : A Case-control Multicentric Study

Resource links provided by NLM:


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

Primary Outcome Measures:
  • 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 ]

Secondary Outcome Measures:
  • 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

Impact of genetic polymorphism on clinical and biological phenotypes linked to food behaviour in infertility context


Estimated Enrollment: 400
Study Start Date: October 2009
Estimated Study Completion Date: September 2014
Primary Completion Date: October 2013 (Final data collection date for primary outcome measure)
Groups/Cohorts
Fertile group
fertile group
Infertility group
Fertility troubles

Detailed Description:

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.

  Eligibility

Ages Eligible for Study:   18 Years to 45 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

Defined population after a screening in out-hospitalized patients in selected investigation sites

Criteria

Inclusion Criteria:

Common to both infertile and fertile couples:

  • Couples where both members are over eighteen and at childbearing age (≤38 for women and ≤ 45 for men)
  • Couples where both members agreed to take part in the study
  • Couples where both members completed a medical check-up and gave an informed consent. Infertile couples could be included following a medical consultation for infertility
  • Couples with none of its member facing any comprehension difficulty in oral or written French language
  • Couples where both members are affiliated to the French NHS [national health service] (beneficiary or legal claimant)

Specific to fertile couples:

- fertile couples who naturally and spontaneously conceived a or many children with a time to conceive shorter than 12 months.

Specific to infertile couples:

  • Infertile couples (primary, infertility, inability to conceive a child after 12 months of unprotected sexual intercourse)
  • Couples where the male partner has sperm parameters compatible with a natural conception
  • Couples where the female partner does not present anovulation, ovarian insufficiency and or any uterus-tubal pathology

Exclusion Criteria:

Common to both infertile and fertile couples:

  • couples where one of the members is under eighteen or not a childbearing age (>38 for women an >45 for men)
  • couples where at least one member refused to give written agreement for the study
  • couples where at least one member shows any known cardiovascular risk (diabetes, hypercholesterolemia, HBR)
  • couples where at least one member shows any known cardiovascular pathology, digestive pathology, no good absorptive pathology or a cancer
  • couples where at least one member faces some difficulty in understanding French language
  • couples where at least one member is not affiliated with the French NHS (beneficiary or legal claimant)

Specific to fertile couples:

•Couples where the woman had a miscarriage or medical termination of pregnancy with current partner

Specific to infertile couples:

  • Couples in which it is not the first pregnancy
  • Couples with the male member showing either:

    • severe oligozoospermia (<5 millions/ml) or a confirmed azoospermia (absence of spermatozoid in the ejaculate)
    • a moderate non idiopathic oligozoospermia (5-20 millions/ml), related to one more of the following factors:

      1. toxic (chemotherapy, radiotherapy, drugs with a demonstrated effect on spermatogenesis)
      2. infectious
      3. anatomic: vasectomy, congenital anomaly (agenesis of vas deferens), long post-traumatic ischemia
      4. endocrine: hypogonadotropic, hypogonadism
      5. cytogenetic: klinefelter syndrome, translocation
  • couples whose male partner shows an abnormality of the male genital tractus : VARICOCEME undescended,testis, testicular volume < 12ml
  • couples whose female partner presents an anovulation, ovarian insufficiency or a proven uterus-tubal pathology
  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: NCT01093378

Locations
France
Laboratoire d'Histologie- Embryologie - Cytogénétique - CECOS
Bondy, France, 93143
Sponsors and Collaborators
Assistance Publique - Hôpitaux de Paris
Institut National de la Santé Et de la Recherche Médicale, France
University Paris 7 - Denis Diderot
Investigators
Principal Investigator: Rachel Levy, MD, PhD AP-HP
  More Information

No publications provided by Assistance Publique - Hôpitaux de Paris

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Assistance Publique - Hôpitaux de Paris
ClinicalTrials.gov Identifier: NCT01093378     History of Changes
Other Study ID Numbers: P071224
Study First Received: February 26, 2010
Last Updated: August 25, 2014
Health Authority: France: Ministry of Health

Keywords provided by Assistance Publique - Hôpitaux de Paris:
Infertility
Obesity
Dietary intake
Fertility
nutrition
diet
weight

Additional relevant MeSH terms:
Infertility
Genital Diseases, Male
Genital Diseases, Female

ClinicalTrials.gov processed this record on October 19, 2014