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NCT Number: NCT06100523

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

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

About this study

  • 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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Visioconsulation

Behavioral

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

Behavioral

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

hair sampling

Biological

hair sampling from the 2 members of the couple

self-assessment questionnaire on dedicated application

Behavioral

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

Specialized follow-up

Behavioral

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

Behavioral

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

Primary outcomes

  1. Clinical live birth rate

    Time frame: 24 months

    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.

Secondary outcomes

  1. Clinical pregnancy rate

    Time frame: 24 months

    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.

  2. Embryology markers

    Time frame: 24 months

    In IVF/ICSI performed in both arms, comparison of fertilization rates, rate of useful embryos (transferred or cryopreserved), embryo implantation rate

  3. Pregnancy markers

    Time frame: 24 months

    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)

  4. Pregnancy markers

    Time frame: 24 months

    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)

  5. Newborn health

    Time frame: at birth

    term,

  6. Behavior changes

    Time frame: 24 months

    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

  7. qualitative analysis

    Time frame: 24 months

    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)

Study contacts

Contact information is provided by the study sponsor or research team.

Claire MORANDO

CONTACT

[email protected]

0(4) 91 38 21 83

Jeanne PERRIN

CONTACT

[email protected]

06 10 48 93 23

Sponsors and collaborators

Lead sponsor

Assistance Publique Hopitaux De Marseille

Other

Registry information

Official study 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

Acronym: PREVENIR-FIV

Important dates

Study start
2024
Primary completion
2026
Study completion
2028
First posted
Oct 25, 2023
Registry last updated
Oct 25, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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