PREVenting-ENvIronment-Reprotoxic Exposures Before In Vitro Fertilization (PREVENIR-FIV) (PREVENIR-FIV)

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

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Infertility
• Intervention / Treatment: Behavioral: Visioconsulation; Biological: hair sampling; Behavioral: self-assessment questionnaire on dedicated application; Behavioral: Specialized follow-up; Behavioral: self-assessment questionnaire for follow-up; Behavioral: self-assessment questionnaire

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.

• Study Type: Interventional
• Enrollment (Estimated): 4224
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Claire MORANDO; Phone Number: 0(4) 91 38 21 83; Email: claire.morando@ap-hm.fr
• Study Contact Backup: Name: Jeanne PERRIN; Phone Number: 06 10 48 93 23; Email: jeanne.perrin@univ-amu.fr

Study Locations

• France
  • Marseille, France, 13005
    • ASSITANCE PUBLIQUE HOPITAUX DE MARSEILLE
    • Contact: Jeanne PERRIN; Phone Number: 06 10 48 93 23; Email: jeanne.perrin@univ-amu.fr

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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	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); 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
Active Comparator: Arm B (standard management); Care path according to the usual modalities of the assisted reproductive treatment (ART) center	Biological: hair sampling; hair sampling from the 2 members of the couple; 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; Behavioral: self-assessment questionnaire; self-administered questionnaire of assessment of reprotoxic exposures, assessment of stress, physical activity, quality of life in infertility course

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Clinical live birth rate	Proportion of couples who obtained at least one live birth during the 24 months of assisted reproductive treatment (ART) treatment (birth(s) obtained after In Vitro Fertilization (IVF)/Intracytoplasmic Sperm Injectionc (ICSI), frozen embryo transfer (FET) from IVF/ICSI, or spontaneous pregnancy obtained between ART treatments), in Arm A versus arm B.	24 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Clinical pregnancy rate	Proportion of couples who achieved at least one clinical pregnancy (presence of gestational sac with cardiac activity at 8 SA) during the 24 months of ART management (pregnancies obtained after IVF/ICSI, frozen embryo transfers (FET) or spontaneously), comparison in both arms.	24 months
Embryology markers	In IVF/ICSI performed in both arms, comparison of fertilization rates, rate of useful embryos (transferred or cryopreserved), embryo implantation rate	24 months
Pregnancy markers	On clinical pregnancies obtained after ART or spontaneously during the 24 months of ART management, comparison in both arms: rates of progressive pregnancies (presence of cardiac activity at 12 weeks of amenorrheae)	24 months
Pregnancy markers	On clinical pregnancies obtained after ART or spontaneously during the 24 months of ART management, comparison in both arms: rates of obstetric pathology (at least one of the following complications = high blood pressure, gestational diabetes, cholestasis, placenta previa, placental abruption, intrauterine growth retardation, missing twin syndrome, premature rupture of membranes, threat of premature delivery, 3rd trimester hemorrhage, preterm birth, postpartum hemorrhage)	24 months
Newborn health	term,	at birth
Behavior changes	evaluation of behavior changes like : consumption of toxic substances, physical activity, eating habits, stress management, protection against environmental/occupational reprotoxins and the quality of life of couples in both arms during follow-up	24 months
qualitative analysis	Qualitative analysis of the brakes and levers related to the adherence of couples to the measures of prevention and correction of reprotoxic exposures proposed during their management in ART (in both arms)	24 months

Collaborators and Investigators

• Sponsor: Assistance Publique Hopitaux De Marseille
• Investigators: Study Director: François Crémieux, Assistance Publique - Hopitaux de Marseille

Study record dates

Study Major Dates

• Study Start (Estimated): January 1, 2024
• Primary Completion (Estimated): January 1, 2026
• Study Completion (Estimated): June 1, 2028

Study Registration Dates

• First Submitted: September 21, 2023
• First Submitted That Met QC Criteria: October 19, 2023
• First Posted (Actual): October 25, 2023

Study Record Updates

• Last Update Posted (Actual): October 25, 2023
• Last Update Submitted That Met QC Criteria: October 19, 2023
• Last Verified: September 1, 2023

More Information

Terms related to this study

• Keywords: Infertility; In Vitro Fertilization; Intracytoplasmic Sperm Injection
• Additional Relevant MeSH Terms: Urogenital Diseases; Genital Diseases; Infertility
• Other Study ID Numbers: RCAPHM21_0387; 2022-A01017-36 (Other Identifier: ID RCB)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No