Clinical trial NCT06074796: The Determinants of Fertility Preservation in TRANSgender Patients.
Official title: The Determinants of Fertility Preservation in TRANSgender Patients (FP-TRANS).
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Fertility Preservation
Transgender
Transgenderism
Keywords: transgender
fertility preservation
parenthood
social determinants
Lead sponsor: Central Hospital, Nancy, France
Sponsor class: OTHER
First posted: 2023-10-10
Enrollment: 230
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Adult 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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: significant result p < 0.05 of qualitative and quantitative data
timeFrame: Statistiques Will be done by December 2023.
Secondary outcomes:
Other outcomes:
Locations:
city: Nancy
country: France
facility: Centre AMP Maternité Régionale de Nancy
Study officials:
affiliation: CentralHNF Nancy Regional University Hospital
name: Mikael AGOPIANTZ, PHD MCU
role: PRINCIPAL_INVESTIGATOR
References:
citation: Mattelin E, Strandell A, Bryman I. Fertility preservation and fertility treatment in transgender adolescents and adults in a Swedish region, 2013-2018. Hum Reprod Open. 2022 Feb 21;2022(2):hoac008. doi: 10.1093/hropen/hoac008. eCollection 2022.