Infertility Clinical Trial
— ALIFERTOfficial title:
Impact of the Diet Fertility : A Case-control Multicentric Study
Verified date | August 2015 |
Source | Assistance Publique - Hôpitaux de Paris |
Contact | n/a |
Is FDA regulated | No |
Health authority | France: Ministry of Health |
Study type | Observational |
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).
Status | Completed |
Enrollment | 400 |
Est. completion date | June 2015 |
Est. primary completion date | October 2013 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 18 Years to 45 Years |
Eligibility |
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 |
Observational Model: Case Control, Time Perspective: Cross-Sectional
Country | Name | City | State |
---|---|---|---|
France | Laboratoire d'Histologie- Embryologie - Cytogénétique - CECOS | Bondy |
Lead Sponsor | Collaborator |
---|---|
Assistance Publique - Hôpitaux de Paris | Institut National de la Santé Et de la Recherche Médicale, France, University Paris 7 - Denis Diderot |
France,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Evaluate the nutritional status of fertile and infertile couples (food questionnaire - biologic, anthropometric and clinical balance). | 24 hours | No | |
Secondary | Impact of genetic polymorphism on clinical and biological phenotypes linked to food behaviour in infertility context (MTHFR polymorphism for folates metabolism) | 12 months | No | |
Secondary | Impact of lifestyle (alcohol and tabacco consumption, physical activity, anxiety and sleep) on diet and fertility | 24 hours | No | |
Secondary | Impact of nutritional status on fertility and ART parameters | 24 hours | No | |
Secondary | Fertility : time to pregnancy (TTP) | in the 6 months | No | |
Secondary | Male infertility : quantitative or qualitative semen abnormalities | in the 6 months | No | |
Secondary | Pregnancy and obstetrical pathologies, prematurity, twin birth, weight of the new-born in infertile couples | in the 6 months | No | |
Secondary | ART parameters, if appropriate | in the 6 months | No |
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