PREVenting-ENvIronment-Reprotoxic Exposures Before In Vitro Fertilization (PREVENIR-FIV)
NCT ID: NCT06100523
Last Updated: 2023-10-25
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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NOT_YET_RECRUITING
NA
4224 participants
INTERVENTIONAL
2024-01-31
2028-06-30
Brief Summary
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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.
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Detailed Description
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* 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.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
OTHER
NONE
Study Groups
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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
Visioconsulation
Meeting by videoconsultation with professionals adapted to the exposures highlighted by the questionnaires for patients who responded on the dedicated application (Arm A)
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
Arm B (standard management)
Care path according to the usual modalities of the assisted reproductive treatment (ART) center
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 for follow-up
self-administered questionnaire of assessment of reprotoxic exposures, assessment of stress, physical activity, quality of life in infertility course
Interventions
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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
Eligibility Criteria
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Inclusion Criteria
* Signature of informed consent by both partners of the couple;
* Possession of a smartphone.
Exclusion Criteria
* 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.
18 Years
ALL
No
Sponsors
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Assistance Publique Hopitaux De Marseille
OTHER
Responsible Party
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Principal Investigators
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François CREMIEUX
Role: STUDY_DIRECTOR
Assistance Publique - Hôpitaux de Marseille
Locations
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Assitance Publique Hôpitaux de Marseille
Marseille, , France
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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2022-A01017-36
Identifier Type: OTHER
Identifier Source: secondary_id
RCAPHM21_0387
Identifier Type: -
Identifier Source: org_study_id
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