NCT06074796

The Determinants of Fertility Preservation in TRANSgender Patients.

The Determinants of Fertility Preservation in TRANSgender Patients (FP-TRANS).

• Status: Unknown
• Phase: —
• Study type: Observational
• Enrollment: 230 (estimated)
• Sponsor: Central Hospital, Nancy, France · Academic / Other
• Sex: All
• Age: 18 Years – 60 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

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.

Conditions

• Fertility Preservation
• Transgender
• Transgenderism

Interventions

Type	Name	Description
BEHAVIORAL	No intervention.	No intervention. This is a retrospective study. Data will have been collected in routine consultations as part of the transition process for transgender patients. Description of the collected informations : gender of destination, BMI, siblings, children, moral, previous hormone therapy, when the project was born, change of marital status desired or carried out, ALD status, psychiatric assessment, desire for future care for the transition course. Desire to preserve erectile function, parenthood desire, couple projections, type of couple, cryopreservation desired, done or not, desire of pregnancy, ultrasound count of antral follicles, initial hormone assays and tests : BMD, pelvic ultrasound? Data relating to stimulation and ovarian puncture and sperm collection.

Timeline

• Start date: 2023-09-25
• Primary completion: 2024-03-01
• Completion: 2024-04-01
• First posted: 2023-10-10
• Last updated: 2024-03-26

Locations

1 site across 1 country: France