Clinical trial

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

Name

RCAPHM21_0387

Description

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.

Trial arms

Trial start

2024-01-01

Estimated PCD

2026-01-01

Trial end

2028-06-01

Status

Not yet recruiting

Treatment

Visioconsulation

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

Arms:

Arm A (interventional)

self-assessment questionnaire

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

Arms:

Arm B (standard management)

hair sampling

hair sampling from the 2 members of the couple

Arms:

Arm A (interventional), Arm B (standard management)

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

Arms:

Arm A (interventional)

Specialized follow-up

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

Arms:

Arm A (interventional)

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

Arms:

Arm A (interventional), Arm B (standard management)

Size

4224

Primary endpoint

Clinical live birth rate

24 months

Eligibility criteria

Inclusion Criteria: * Couple eligible for a first attempt of conventional In Vitro Fertilization (IVF) or Intra Cytoplasmic Sperm Injection (IVF-ICSI) intra-marital; * Signature of informed consent by both partners of the couple; * Possession of a smartphone. Exclusion Criteria: * Not fluent in the language; * Refusal to participate in the study of one or both members of the couple; * Use of cryopreserved intra-conjugal gametes before management in MPA; * Use of gamete donation, embryo reception; * History of chemotherapy/radiotherapy; * Support in viral risk circuit; * Not having a smartphone.

Protocol

{'studyType': 'INTERVENTIONAL', 'phases': ['NA'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'PARALLEL', 'primaryPurpose': 'OTHER', 'maskingInfo': {'masking': 'NONE'}}, 'enrollmentInfo': {'count': 4224, 'type': 'ESTIMATED'}}

Updated at

2023-10-25

1 organization

1 product

1 indication

Organization

Assistance Publique Hopitaux De Marseille

Product

Hair Sampling

Indication

infertility