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NOT YET RECRUITING
NCT06100523
NA

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

Sponsor: Assistance Publique Hopitaux De Marseille

View on ClinicalTrials.gov

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.

Official title: Multidisciplinary Platform Designed to Reduce and Prevent Environmental Reprotoxic Exposures in Subfertile Couples: Assessment of the Contribution of Such Platforms on the Birth Rate After In Vitro Fertilization: Randomized Open Prospective Comparative Multicentric Study

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

4224

Start Date

2024-01

Completion Date

2028-06

Last Updated

2023-10-25

Healthy Volunteers

No

Conditions

Interventions

BEHAVIORAL

Visioconsulation

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

BEHAVIORAL

self-assessment questionnaire

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

BIOLOGICAL

hair sampling

hair sampling from the 2 members of the couple

BEHAVIORAL

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

BEHAVIORAL

Specialized follow-up

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

BEHAVIORAL

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

Locations (1)

Assitance Publique Hôpitaux de Marseille

Marseille, France