Ignite Creation Date:
2025-12-24 @ 10:56 PM
Ignite Modification Date:
2025-12-25 @ 8:24 PM
Study NCT ID:
NCT07138469
Status:
COMPLETED
Last Update Posted:
2025-08-22
First Post:
2025-06-25
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
FRench Elective Oocyte prEservation: a Multicenter Study thrEe Years Later
Sponsor:
University Hospital, Clermont-Ferrand
Organization:
Study Overview
Official Title:
Overview of Elective Oocyte Preservation Three Years After Its Authorization in France: a Nationwide Multicenter Study
Status:
COMPLETED
Status Verified Date:
2025-06
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
FREEZE-FR
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.
Detailed Description:
This is a multicenter descriptive study conducted by the AMP-CECOS unit of the Clermont-Ferrand University Hospital between November 2023 and June 2024, with the participation of CECOS centers across mainland France. This national survey is carried out using an anonymous online questionnaire (Google Forms) developed at ART unit of Clermont Ferrand University Hospital and approved by the entire clinico-biological team. The study was submitted for ethical approval and compliance with the General Data Protection Regulation (GDPR) and received a favorable opinion from the Ethics Committee of the Clinical Research and Innovation Department (DRCI) of the Clermont-Ferrand University Hospital on July 24, 2023. The project was also presented to the scientific committee of the CECOS federation and published on two national reference platforms for fertility. Then, an envelope containing 50 flyers along with an explanatory note was sent by post to the 31 CECOS centers in mainland France.
Included in this study were women in a fertility preservation process for non-medical reasons, who have been seen in consultation as part of a request for non-medical fertility preservation, as well as women who have already undergone non-medical fertility preservation in France since its authorization on August 2, 2021. The inclusion criteria were those applicable to non-medical fertility preservation, being between 29 and 37 years of age at the time of care and not meeting the criteria for fertility preservation for medical reasons. An anonymous questionnaire using the Google Forms tool was elaborated by myself and approved by the clinico-biological team of the AMP-CECOS unit at the Clermont-Ferrand University Hospital. The survey takes only a few minutes to complete. It consisted of 18 questions, including open-ended (O), single-choice (SCQ), and multiple-choice (MCQ) questions. For most questions, a response was not mandatory to proceed with the questionnaire, in case participants prefer not to answer. To access the online survey, a flyer was prepared in advance and given to participants during their consultation. It includes the address https://bit.ly/enquete.fertilite and a QR code linking to the survey. A digital version was also sent by email to women who have already undergone oocyte cryopreservation. Three main themes emerged from the questionnaire. The first concerned the socio-economic and demographic data of the study population: department of residence, age, family status, parenthood, and level of education (SCQ). The second concerned the knowledge of the bioethics law governing the EFP (SCQ) and gamete donation (SCQ) and the third concerned the perspectives of participants for the use of cryopreserved oocytes (MCQ) and in case of non-use (MCQ).
Included in this study were women in a fertility preservation process for non-medical reasons, who have been seen in consultation as part of a request for non-medical fertility preservation, as well as women who have already undergone non-medical fertility preservation in France since its authorization on August 2, 2021. The inclusion criteria were those applicable to non-medical fertility preservation, being between 29 and 37 years of age at the time of care and not meeting the criteria for fertility preservation for medical reasons. An anonymous questionnaire using the Google Forms tool was elaborated by myself and approved by the clinico-biological team of the AMP-CECOS unit at the Clermont-Ferrand University Hospital. The survey takes only a few minutes to complete. It consisted of 18 questions, including open-ended (O), single-choice (SCQ), and multiple-choice (MCQ) questions. For most questions, a response was not mandatory to proceed with the questionnaire, in case participants prefer not to answer. To access the online survey, a flyer was prepared in advance and given to participants during their consultation. It includes the address https://bit.ly/enquete.fertilite and a QR code linking to the survey. A digital version was also sent by email to women who have already undergone oocyte cryopreservation. Three main themes emerged from the questionnaire. The first concerned the socio-economic and demographic data of the study population: department of residence, age, family status, parenthood, and level of education (SCQ). The second concerned the knowledge of the bioethics law governing the EFP (SCQ) and gamete donation (SCQ) and the third concerned the perspectives of participants for the use of cryopreserved oocytes (MCQ) and in case of non-use (MCQ).
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?: