NCT06100523

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.

Trial Health

63
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Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
4,224

participants targeted

Target at P75+ for not_applicable

Timeline
25mo left

Started Jan 2024

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress53%
Jan 2024Jun 2028

First Submitted

Initial submission to the registry

September 21, 2023

Completed
1 month until next milestone

First Posted

Study publicly available on registry

October 25, 2023

Completed
2 months until next milestone

Study Start

First participant enrolled

January 1, 2024

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2026

Completed
2.4 years until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2028

Expected
Last Updated

October 25, 2023

Status Verified

September 1, 2023

Enrollment Period

2 years

First QC Date

September 21, 2023

Last Update Submit

October 19, 2023

Conditions

Infertility

Keywords

InfertilityIn Vitro FertilizationIntracytoplasmic Sperm Injection

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (7)

  • Clinical pregnancy rate

    24 months

  • Embryology markers

    24 months

  • Pregnancy markers

    24 months

  • Pregnancy markers

    24 months

  • Newborn health

    at birth

  • +2 more secondary outcomes

Study Arms (2)

Arm A (interventional)

EXPERIMENTAL

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: VisioconsulationBiological: hair samplingBehavioral: self-assessment questionnaire on dedicated applicationBehavioral: Specialized follow-upBehavioral: self-assessment questionnaire for follow-up

Arm B (standard management)

ACTIVE COMPARATOR

Care path according to the usual modalities of the assisted reproductive treatment (ART) center

Behavioral: self-assessment questionnaireBiological: hair samplingBehavioral: self-assessment questionnaire for follow-up

Interventions

VisioconsulationBEHAVIORAL

Meeting by videoconsultation with professionals adapted to the exposures highlighted by the questionnaires for patients who responded on the dedicated application (Arm A)

Arm A (interventional)
self-assessment questionnaireBEHAVIORAL

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

Arm B (standard management)
hair samplingBIOLOGICAL

hair sampling from the 2 members of the couple

Arm A (interventional)Arm B (standard management)
self-assessment questionnaire on dedicated applicationBEHAVIORAL

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

Arm A (interventional)
Specialized follow-upBEHAVIORAL

proactive healthcare pathway : active support of corrective measures implemented with couples by the platform, with the help of the application

Arm A (interventional)
self-assessment questionnaire for follow-upBEHAVIORAL

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

Arm A (interventional)Arm B (standard management)

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Assitance Publique Hôpitaux de Marseille

Marseille, 13005, France

Location

Related Publications (1)

  • 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 birth rate after assisted reproduction treatment. Trials. 2025 Dec 22;26(1):575. doi: 10.1186/s13063-025-09208-8.

    PMID: 41430276DERIVED

MeSH Terms

Conditions

Infertility

Condition Hierarchy (Ancestors)

Genital DiseasesUrogenital Diseases

Study Officials

  • François CREMIEUX

    Assistance Publique - Hôpitaux de Marseille

    STUDY DIRECTOR

Central Study Contacts

Jeanne PERRIN

CONTACT

06 10 48 93 23jeanne.perrin@univ-amu.fr

Claire MORANDO

CONTACT

0(4) 91 38 21 83claire.morando@ap-hm.fr

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
OTHER
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 21, 2023

First Posted

October 25, 2023

Study Start

January 1, 2024

Primary Completion

January 1, 2026

Study Completion (Estimated)

June 1, 2028

Last Updated

October 25, 2023

Record last verified: 2023-09

Locations

FR(1)