The Determinants of Fertility Preservation in TRANSgender Patients.

Transgenderism Clinical Trial

— FP-TRANS  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06074796
• Other study ID #: 2023PI127-413
• Status: Recruiting
• Start date: September 25, 2023
• Est. completion date: April 2024

Study information

• Verified date: March 2024
• Source: Central Hospital, Nancy, France
• Contact: Mikael Agopiantz Agopiantz, PHD
• Phone: 0033671038224
• Email: mikael.agopiantz[@]gmail.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 230
• Est. completion date: April 2024
• Est. primary completion date: March 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 60 Years

Eligibility

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

Related Conditions & MeSH terms

• Fertility Preservation
• Transgender
• Transgenderism

Intervention

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.

Locations

Country	Name	City	State
France	Centre AMP Maternité Régionale de Nancy	Nancy

Sponsors (1)

Lead Sponsor	Collaborator
Central Hospital, Nancy, France

Country where clinical trial is conducted

France, 

References & Publications (1)

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	significant result p < 0.05 of qualitative and quantitative data	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.	Statistiques Will be done by December 2023.