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

Sponsor
Central Hospital, Nancy, France (Other)
Overall Status
Recruiting
CT.gov ID
NCT06074796
Collaborator
(none)
230
1
3.2
72.9

Study Details

Study Description

Brief 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.

Condition or Disease Intervention/Treatment Phase
  • Behavioral: No intervention.

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.

Study Design

Study Type:
Observational
Anticipated Enrollment :
230 participants
Observational Model:
Cohort
Time Perspective:
Retrospective
Official Title:
The Determinants of Fertility Preservation in TRANSgender Patients (FP-TRANS).
Actual Study Start Date :
Sep 25, 2023
Anticipated Primary Completion Date :
Nov 3, 2023
Anticipated Study Completion Date :
Dec 30, 2023

Arms and Interventions

Arm Intervention/Treatment
Transgender patients

Patients included are transgender patients who have had routine consultations as part of the transition process for transgender patients, done in the reproductive medicine department of the regional university hospital centre in Nancy. Exclusion criteria : minors, patients under guardianship or trusteeship. French laws allow embryo transfer until 45 years for women and sperm reuse up to 60 years for men, so patients older have been excluded.

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.

Outcome Measures

Primary Outcome Measures

  1. significant result p < 0.05 of qualitative and quantitative data [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.

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 60 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
Inclusion Criteria:
  • Transgender patients who consulted the Assisted Reproductive Technology centre of the Nancy Regional University Hospital, between 1st January 2020 and 30th June 2023. The consultations occurred for the start of transition care, for follow-up or for a parenting project for transgender patients.
Exclusion Criteria:
  • minors

  • patients under guardianship or under tutelage

Contacts and Locations

Locations

Site City State Country Postal Code
1 Centre AMP Maternité Régionale de Nancy Nancy France 54000

Sponsors and Collaborators

  • Central Hospital, Nancy, France

Investigators

  • Principal Investigator: Mikael AGOPIANTZ, PHD MCU, CentralHNF Nancy Regional University Hospital

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Mikael AGOPIANTZ, MCU Dr AGOPIANTZ Mikaël, Central Hospital, Nancy, France
ClinicalTrials.gov Identifier:
NCT06074796
Other Study ID Numbers:
  • 2023PI127-413
First Posted:
Oct 10, 2023
Last Update Posted:
Oct 10, 2023
Last Verified:
Oct 1, 2023
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Mikael AGOPIANTZ, MCU Dr AGOPIANTZ Mikaël, Central Hospital, Nancy, France

Study Results

No Results Posted as of Oct 10, 2023