Clinical trial NCT06100523: PREVenting-ENvIronment-Reprotoxic Exposures Before In Vitro Fertilization (PREVENIR-FIV)
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
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Infertility
Keywords: Infertility
In Vitro Fertilization
Intracytoplasmic Sperm Injection
Lead sponsor: Assistance Publique Hopitaux De Marseille
Sponsor class: OTHER
First posted: 2023-10-25
Enrollment: 4224
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

Brief 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.

Detailed description: * Arm A (interventional): analysis of the responses to the self-administered questionnaires with, if necessary, protocol interview concerning environmental and occupational factors, which will determine the consultations to be planned for their follow-up by the platform. - support of couples by the multidisciplinary platform with the help of the downloaded application: Meeting by videoconsultation with professionals adapted to the exposures highlighted by the questionnaires. Multidisciplinary Synthesis (MS): Synthesis of the first consultations and the results of the self-questionnaires by the multidisciplinary team. Determination of preventive and corrective measures, specific advice, specialized follow-up if necessary. Presentation to patients of the personalized measures decided in MS: information on the personalized management proposed (follow-up addictologist, dietician, psychologist, occupational doctor), personalized advice sheets. Couples who do not require personalized measures will continue their treatment with prevention advice adapted to their profession and their environment. Transmission of the minutes of the MS to the clinician in charge of the couple.
* Arm B (standard management): care path according to the usual modalities of the ART center (indications, network of practitioners, monitoring and information tools). If necessary, distribution by the clinician of information leaflets on addictions, dietetics + distribution of a general information leaflet on reprotoxic factors.

In both arms: embryology consultation before ART: information on the planned ART. Information on the online self-assessment questionnaire for assessing reprotoxic exposures, assessing stress, physical activity, and quality of life during infertility. In centers with a biological resource center Germethèque, hair sampling from the 2 members of the couple.

First attempt of IVF/ICSI, in both arms, followed for 24 months with every 6 months: information of the online self-administered questionnaire of assessment of reprotoxic exposures, assessment of stress, physical activity, quality of life in infertility course. At 12 months and 24 months: hair sampling from both members of the couple (in Germethèque centers only).

- In arm A during the 24 months of follow-up: active support of corrective measures implemented with couples by the platform, with the help of the application (weight loss goals, changes in habits, physical activity, decreased or stopped toxics). Continuation of specialized follow-up if necessary, in videoconsultation.

At the end of the study: a sample of about twenty couples in each arm will be the subject of a semi-directed interview aimed at qualitatively determining the brakes and levers to their adherence to the environmental health advice received during their management in ART.

Medical-economic analysis: a cost-effectiveness analysis and a budget impact analysis will be carried out by the Epidemiology and Health Economics Department.

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.

Primary outcomes:
measure: Clinical live birth rate
timeFrame: 24 months
Secondary outcomes:
measure: Clinical pregnancy rate
timeFrame: 24 months
measure: Embryology markers
timeFrame: 24 months
measure: Pregnancy markers
timeFrame: 24 months
measure: Pregnancy markers
timeFrame: 24 months
measure: Newborn health
timeFrame: at birth
measure: Behavior changes
timeFrame: 24 months
measure: qualitative analysis
timeFrame: 24 months
Other outcomes:
Locations:
city: Marseille
country: France
facility: Assitance Publique Hôpitaux de Marseille
Study officials:
affiliation: Assistance Publique - Hôpitaux de Marseille
name: François CREMIEUX
role: STUDY_DIRECTOR
References: