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The Determinants of Fertility Preservation in TRANSgender Patients.

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

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT06074796
Acronym
FP-TRANS
Enrollment
230
Registered
2023-10-10
Start date
2023-09-25
Completion date
2024-04-30
Last updated
2024-03-26

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Fertility Preservation, Transgender, Transgenderism

Keywords

transgender, fertility preservation, parenthood, social determinants

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.

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.

Interventions

BEHAVIORALNo 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.

Sponsors

Central Hospital, Nancy, France
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
RETROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to 60 Years
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

Design outcomes

Primary

MeasureTime frameDescription
significant result p < 0.05 of qualitative and quantitative dataStatistiques 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.

Countries

France

Contacts

Primary ContactMikael Agopiantz Agopiantz, PHD
mikael.agopiantz@gmail.com0033671038224
Backup ContactMikael Agopiantz, PHD
mikael.agopiantz@gmail.com0033671038224

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026