PREVenting-ENvIronment-Reprotoxic Exposures Before In Vitro Fertilization (PREVENIR-FIV)
NCT06100523 · Status: NOT_YET_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 4224
Last updated 2023-10-25
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.
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
Sponsors & Collaborators
-
Assistance Publique Hopitaux De Marseille
lead OTHER
Principal Investigators
-
François CREMIEUX · Assistance Publique - Hôpitaux de Marseille
Study Design
- Allocation
- RANDOMIZED
- Purpose
- OTHER
- Masking
- NONE
- Model
- PARALLEL
Eligibility
- Min Age
- 18 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2024-01-31
- Primary Completion
- 2026-01-31
- Completion
- 2028-06-30
Countries
- France
Study Locations
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