跳至主要内容
临床试验/NCT07138469
NCT07138469已完成不适用

Overview of Elective Oocyte Preservation Three Years After Its Authorization in France: a Nationwide Multicenter Study

University Hospital, Clermont-Ferrand1 个研究点 分布在 1 个国家目标入组 351 人开始时间: 2023年11月1日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
351
试验地点
1
主要终点
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.

研究概览

简要总结

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.

详细描述

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).

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

年龄范围
29 Years 至 37 Years(Adult)
性别
Female
接受健康志愿者
否

入选标准

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

排除标准

  • •Women who had criteria for medical fertility preservation

结局指标

主要结局

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.

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

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

次要结局

  • 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))

研究者

发起方
University Hospital, Clermont-Ferrand
申办方类型
Other
责任方
Sponsor

研究点 (1)

Loading locations...

相似试验