PREVenting-ENvIronment-Reprotoxic Exposures Before In Vitro Fertilization (PREVENIR-FIV)
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Visioconsulation, self-assessment questionnaire, hair sampling, self-assessment questionnaire on dedicated application.
- Who it may be relevant to
- Registry conditions: Infertility. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- France
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
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
Overview
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.
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
Primary outcome measures
- Clinical live birth rate [Time frame: 24 months]
Secondary outcome measures (7)
- Clinical pregnancy rate [Time frame: 24 months]
- Embryology markers [Time frame: 24 months]
- Pregnancy markers [Time frame: 24 months]
- Pregnancy markers [Time frame: 24 months]
- Newborn health [Time frame: at birth]
- Behavior changes [Time frame: 24 months]
- qualitative analysis [Time frame: 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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Open label
- Primary purpose
- Other
Study locations
France · 1 center
- Assitance Publique Hôpitaux de Marseille — Marseille
Publications
- Sunyach C, Courbiere B, Simon N, Delva F, Garlantezec R, Bretelle F, Leandri R, Gehanno JF, Esquirol Y, Loubiere S, Resseguier N, Sari-Minodier I, Perrin J. PREVENIR-IVF: study protocol for a prospective multicentre randomized open comparative trial, which explores the efficacy of a multidisciplinary platform reducing and preventing reprotoxic environmental exposures in subfertile couples on live PMID 41430276
Identifiers
NCT: NCT06100523 · RCAPHM21_0387 · 2022-A01017-36