NCT07138469

Brief Summary

Previously reserved for pathological cases, oocyte cryopreservation for non-medical reason also named elective fertility preservation (EFP) is now authorized in France for women aged 29 to 37 following the revision of the bioethics law on August 2nd 2021. Currently, French data related to this new practice are lacking. The aim of this study is to conduct a preliminary assessment 3 years after approval of elective oocyte cryopreservation in France, evaluating the knowledge and perspectives of women undergoing elective fertility preservation in order to gain a better understanding of this new population and define the socio-economic and demographic profiles to improve care quality.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
351

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Nov 2023

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

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 Start

First participant enrolled

November 1, 2023

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 30, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 30, 2024

Completed
12 months until next milestone

First Submitted

Initial submission to the registry

June 25, 2025

Completed
2 months until next milestone

First Posted

Study publicly available on registry

August 22, 2025

Completed
Last Updated

August 22, 2025

Status Verified

June 1, 2025

Enrollment Period

8 months

First QC Date

June 25, 2025

Last Update Submit

August 21, 2025

Conditions

Outcome Measures

Primary Outcomes (1)

  • Questionnaire to better define the demographic characteristics, knowledge, and perspectives of women who have undergone or wish to undergo oocyte cryopreservation for non-medical reasons.

    Department of residence, age group, stage of process, family status, marital status, education level, motivation, sources of information, knowledge of limit age for oocyte use, probability of use, perspectives of using cryopreserved oocytes: intended family model, perspectives in case of non-use of cryopreserved oocytes, knowledge of the bioethics law on the right of access to origins governing gamete donation

    7 months (01/11/2023 to 30/06/2024)

Secondary Outcomes (1)

  • Analysis of questionnaire responses based on whether or not fertility preservation has been performed, to assess the impact of the care stage on knowledge of the bioethics law.

    7 months (01/11/2023 to 30/06/2024)

Study Arms (1)

women engaged in an elective fertility preservation process

women engaged in an elective fertility preservation process and who agree to participate in the study by completing the questionnaire

Other: Questionnaire

Interventions

The questionnaire was offered on a voluntary basis and completed online by the participants. At the end of the inclusion period, the responses were analyzed. Participant indicated in the questionnaire whether or not they had already undergone oocyte cryopreservation. The responses were analyzed to assess demographic characteristics, the level of knowledge regarding the bioethics law on non-medical fertility preservation, and future perspectives in the event of use (desired parental model, likelihood of use) or non-use.

Also known as: Questionnaire developed by the AMP-CECOS unit of the Clermont-Ferrand University Hospital and approved by the ART unit team.
women engaged in an elective fertility preservation process

Eligibility Criteria

Age29 Years - 37 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64)
Sampling MethodNon-Probability Sample
Study Population

women engaged in an elective fertility preservation process and who agree to participate in the study by completing the questionnaire

You may qualify if:

  • Being in SFP process
  • Undergone SFP
  • to 37 years of age at the time of SFP or process

You may not qualify if:

  • Women who had criteria for medical fertility preservation

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

CHU de Clermont-Ferrand

Clermont-Ferrand, Auvergne, 63000, France

Location

MeSH Terms

Interventions

Surveys and Questionnaires

Intervention Hierarchy (Ancestors)

Data CollectionEpidemiologic MethodsInvestigative TechniquesHealth Care Evaluation MechanismsQuality of Health CareHealth Care Quality, Access, and EvaluationPublic HealthEnvironment and Public Health

Study Officials

  • Jeanne Dufaure, MD

    University Hospital, Clermont-Ferrand

    PRINCIPAL INVESTIGATOR
  • Florence Brugnon, MD,PhD,HDR

    University Hospital, Clermont-Ferrand

    STUDY DIRECTOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 25, 2025

First Posted

August 22, 2025

Study Start

November 1, 2023

Primary Completion

June 30, 2024

Study Completion

June 30, 2024

Last Updated

August 22, 2025

Record last verified: 2025-06

Locations