PREVenting-ENvIronment-Reprotoxic Exposures Before In Vitro Fertilization (PREVENIR-FIV)

Condition(s) studied

Investigational drug(s) / intervention(s)

Visioconsulation: Meeting by videoconsultation with professionals adapted to the exposures highlighted by the questionnaires for patients who responded on the dedicated application (Arm A)

self-assessment questionnaire: self-administered questionnaire of assessment of reprotoxic exposures, assessment of stress, physical activity, quality of life in infertility course

hair sampling: hair sampling from the 2 members of the couple

self-assessment questionnaire on dedicated application: self-administered questionnaire of assessment of reprotoxic exposures, assessment of stress, physical activity, quality of life in infertility course

Specialized follow-up: proactive healthcare pathway : active support of corrective measures implemented with couples by the platform, with the help of the application

self-assessment questionnaire for follow-up: self-administered questionnaire of assessment of reprotoxic exposures, assessment of stress, physical activity, quality of life in infertility course

Study summary

The objective is to evaluate the effectiveness of an innovative personalized management strategy adapted to the level of environmental risk, in a population of infertile couples, eligible for assisted reproductive treatment (ART) by intraconjugal In Vitro Fertilization (IVF)/ Intracytoplasmic sperm injection (ICSI).

Consultation of the couple at the ARTcenter : - Prescriptions of the standard assessment of infertility to the couples eligible for ART. - Inclusion and randomization (arm A interventional vs arm B standard management) of the couples having signed the consent. - Information for each patient on a standardized online self questionnaire on environmental exposures, physical activity and stress.

Eligibility

Primary outcome measure(s)

• Clinical live birth rate — 24 months
  Proportion of couples who obtained at least one live birth during the 24 months of assisted reproductive treatment (ART) treatment (birth(s) obtained after In Vitro Fertilization (IVF)/Intracytoplasmic Sperm Injectionc (ICSI), frozen embryo transfer (FET) from IVF/ICSI, or spontaneous pregnancy obtained between ART treatments), in Arm A versus arm B.

Trial sites (1)

More Assistance Publique Hopitaux De Marseille trials in France

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