Clinical trial NCT01093378: Diet and Its Relationship With Couple Infertility
Official title: Impact of the Diet Fertility : A Case-control Multicentric Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Infertility
Keywords: Infertility
Obesity
Dietary intake
Fertility
nutrition
diet
weight
Lead sponsor: Assistance Publique - Hôpitaux de Paris
Sponsor class: OTHER
Collaborators: name: Institut National de la Santé Et de la Recherche Médicale, France
name: University Paris 7 - Denis Diderot
First posted: 2010-03-25
Enrollment: 400
Sex: ALL
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Defined population after a screening in out-hospitalized patients in selected investigation sites

Brief summary: 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).

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 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

Primary outcomes:
measure: Evaluate the nutritional status of fertile and infertile couples (food questionnaire - biologic, anthropometric and clinical balance).
timeFrame: 24 hours
Secondary outcomes:
measure: Impact of genetic polymorphism on clinical and biological phenotypes linked to food behaviour in infertility context (MTHFR polymorphism for folates metabolism)
timeFrame: 12 months
measure: Impact of lifestyle (alcohol and tabacco consumption, physical activity, anxiety and sleep) on diet and fertility
timeFrame: 24 hours
measure: Impact of nutritional status on fertility and ART parameters
timeFrame: 24 hours
measure: Fertility : time to pregnancy (TTP)
timeFrame: in the 6 months
measure: Male infertility : quantitative or qualitative semen abnormalities
timeFrame: in the 6 months
measure: Pregnancy and obstetrical pathologies, prematurity, twin birth, weight of the new-born in infertile couples
timeFrame: in the 6 months
measure: ART parameters, if appropriate
timeFrame: in the 6 months
Other outcomes:
Locations:
city: Bondy
country: France
facility: Laboratoire d'Histologie- Embryologie - Cytogénétique - CECOS
Study officials:
affiliation: Assistance Publique - Hôpitaux de Paris
name: Rachel Levy, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Bachelot G, Levy R, Bachelot A, Faure C, Czernichow S, Dupont C, Lamaziere A; Alifert Collaborative Group. Proof of concept and development of a couple-based machine learning model to stratify infertile patients with idiopathic infertility. Sci Rep. 2021 Dec 14;11(1):24003. doi: 10.1038/s41598-021-03165-3.
citation: Talla P, Faure C, Rigourd V, Czernichow S, Sermondade N, Levy R, Dupont C; ALIFERT collaborative group. Is There an Association of Being Breastfed as an Infant and Fertility Status as an Adult? Breastfeed Med. 2021 May;16(5):414-418. doi: 10.1089/bfm.2020.0130. Epub 2021 Mar 30.
citation: Dupont C, Hulot A, Jaffrezic F, Faure C, Czernichow S, di Clemente N, Racine C, Chavatte-Palmer P, Levy R; Alifert group. Female ponderal index at birth and idiopathic infertility. J Dev Orig Health Dis. 2020 Apr;11(2):154-158. doi: 10.1017/S2040174419000394. Epub 2019 Jul 16.
citation: Dupont C, Faure C, Daoud F, Gautier B, Czernichow S, Levy R; ALIFERT collaborative group. Metabolic syndrome and smoking are independent risk factors of male idiopathic infertility. Basic Clin Androl. 2019 Jul 1;29:9. doi: 10.1186/s12610-019-0090-x. eCollection 2019.
citation: Faure C, Dupont C, Chavatte-Palmer P, Gautier B, Levy R; ALIFERT Collaborative Group. Are semen parameters related to birth weight? Fertil Steril. 2015 Jan;103(1):6-10. doi: 10.1016/j.fertnstert.2014.11.027.
citation: Faure C, Leveille P, Dupont C, Julia C, Chavatte-Palmer P; Alifert Group; Sutton A, Levy R. Are superoxide dismutase 2 and nitric oxide synthase polymorphisms associated with idiopathic infertility? Antioxid Redox Signal. 2014 Aug 1;21(4):565-9. doi: 10.1089/ars.2014.5831. Epub 2014 Feb 25.