Transgender Caregivers' and Patients' Representations of Parenthood as Part of a Fertility Preservation Pathway

Fertility Issues Clinical Trial

— TransFert  

Official title:

Transgender Caregivers' and Patients' Representations of Parenthood as Part of a Fertility Preservation Pathway

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06218446
• Other study ID #: APHP230413
• Secondary ID: 2023-A00509-36
• Status: Not yet recruiting
• Start date: February 2024
• Est. completion date: April 2024

Study information

• Verified date: January 2024
• Source: Assistance Publique - Hôpitaux de Paris
• Contact: Emilie MOREAU
• Phone: 00 33 6 87 13 08 31
• Email: Emilie.moreau[@]aphp.fr
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

This research aims to understand the impact of fertility preservation consultation on transgender patients' projection and how the possibility of preserving gametes influences transgender people's transition paths, parenthood projects and health and health of transgender people through qualitative interviews.

This research will also study the representations of members of medical and reproductive biology teams the possible use of stored gametes, and how these representations influence their clinical practice.

clinical practice. To answer the research question, we plan to include 30 patients who have consulted for fertility preservation at the at the CECOS of the Tenon hospital, located in the 20th arrondissement of Paris, and 20 members of the center's healthcare team.

care team.

Description:

Since the 2016 law, transgender people no longer need to provide "irreversible and medical proof of a physical transformation" in order to carry out a sex change at the Civil Registry, which puts an end to systematic sterilization and opens up the possibility of a hormonal-only transition. Yet hormonal treatments can have an impact on the fertility of transgender people, compromising a subsequent project for parenthood.

The Reproductive Biology department at Tenon, where the research will take place, now offers self-conservation of female and male gametes before hormone replacement treatments are introduced, or during a therapeutic window. Fertility preservation in transgender women relies primarily on sperm self-preservation. For transgender men, fertility preservation relies on cryopreservation of mature oocytes after ovarian stimulation.

In addition to assessing the psychic impact of care in order to prevent potential deleterious effects, psycho-sexological consultation offers an opportunity to express the desire for a child, a desire often inhibited for a long time, as well as information on the possibilities of reuse.

When it comes to research around the issue of fertility preservation for transgender people, there is often talk of problems concerning access to this care: the discriminatory practices of certain centers that refuse transgender people, the lack of training in transidentity issues for care teams, etc. The coercive weight of the law seems to be enough to evade the issue by moving it into the realm of legislation. And yet, in our clinical experience, the question of gamete reuse is a subject that merits research to determine the obstacles and levers for both caregivers and patients.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 50
• Est. completion date: April 2024
• Est. primary completion date: April 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Any transgender person undergoing fertility preservation in the department

• Any member of the reproductive biology and medicine services team

• Aged 18 and over, with or without children

• Informed and having signed consent to participate in the research project

Exclusion Criteria:

• No social security

• Persons under guardianship

Related Conditions & MeSH terms

• Fertility Issues
• Infertility
• Transgenderism

Locations

Country	Name	City	State
France	CECOS / service de Biologie de la Reproduction Hôpital Tenon	Paris

Sponsors (1)

Lead Sponsor	Collaborator
Assistance Publique - Hôpitaux de Paris

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of patients surveyed who developed or modified a gamete-use project following the fertility preservation consultation.	To understand the impact of the fertility preservation consultation on transgender patients' projection in terms of parenthood.	Up to 2 months
Secondary	number of caregivers who raise the issue of gamete reuse during their consultations.	To study the way in which caregivers perceive the possible use of preserved gametes, and how these perceptions influence their clinical practice.	Up to 2 months
Secondary	number of members of the healthcare team who have changed their practice since the service began accepting transgender patients	To study the way in which caregivers perceive the possible use of preserved gametes, and how these perceptions influence their clinical practice.; criteria:	Up to 2 months
Secondary	Number of patients who have developed a parental project following consultation with the psychologist.		Up to 2 months
Secondary	Number of patients who are aware of the law and their rights in terms of gamete preservation and use		Up to 2 months
Secondary	Number of patients who have modified the temporality of their transition (medical and/or administrative) because of their preservation path and/or their desire for parenthood.		Up to 2 months
Secondary	Number of patients for whom the intention to preserve their gametes is experienced as improving their transition path.		Up to 2 months