The Determinants of Fertility Preservation in TRANSgender Patients (FP-TRANS).
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 230
- 试验地点
- 1
- 主要终点
- significant result p < 0.05 of qualitative and quantitative data
研究概览
简要总结
The study is monocentric, retrospective, non-interventional and does not involve human subjects.
The main objective is to compare the profiles of transgender patients who undergo fertility preservation with those who do not.
The secondary objectives are to define the rate of recourse to fertility preservation, determine the proportion of patients wishing to become parents.
Statistical analysis will be carried out with a view to highlighting significant determinants in transgender patients by comparing those who undergo fertility preservation with those who do not.
The data will have been collected during routine consultations as part of the transition process for transgender patients. This is taking place in the reproductive medicine department of the regional university hospital centre in Nancy.
详细描述
This study aims to assess the determinants of fertility preservation (FP) among transgender patients at the University Regional Hospital Center (CHRU) of Nancy. The secondary objective was to establish a database to gain a deeper understanding of the challenges related to fertility preservation in the context of a transition project and thus provide more tailored support to transgender patients.
The primary endpoint is the significativity of profiles elements of transgender patients who undergo fertility preservation with those who do not.
It may help the understanding of the determinants of fertility preservation in transgender patients.
We expect to include between 200 and 300 patients. The data will be transcribed onto the anonymised data collection Excel sheet. Statistical analysis of qualitative and quantitative data will be carried out with a view to highlighting significant determinants in transgender patients by comparing those who undergo fertility preservation with those who do not.
The study is monocentric, retrospective, non-interventional and does not involve human subjects. In fact, this research is based on existing data, extracted from patient files in the médifirst software. The data will have been collected during routine consultations as part of the transition process for transgender patients. This is taking place in the reproductive medicine department of the regional university hospital centre in Nancy.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Retrospective
入排标准
- 年龄范围
- 18 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Transgender patients who consulted the Assisted Reproductive Technology centre of the Nancy Regional University Hospital, between 1st January 2020 and 30th June
- •The consultations occurred for the start of transition care, for follow-up or for a parenting project for transgender patients.
排除标准
- •patients under guardianship or under tutelage
结局指标
主要结局
significant result p < 0.05 of qualitative and quantitative data
时间窗: Statistiques Will be done by December 2023.
The significance of statistical tests (significant result p \< 0.05) will show whether or not there are emerging determinants in each of the 2 groups: fertility preservation done / not done. Qualitative data will be available in the medical files created during the appointments of transgender patients who have consulted the Reproductive Medicine Department.
次要结局
未报告次要终点
研究者
Mikael AGOPIANTZ
head of the ART center, Principal Investigator
Central Hospital, Nancy, France