NCT06218446

Brief 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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
50

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Feb 2024

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

December 19, 2023

Completed
1 month until next milestone

First Posted

Study publicly available on registry

January 23, 2024

Completed
9 days until next milestone

Study Start

First participant enrolled

February 1, 2024

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2024

Completed
Last Updated

January 23, 2024

Status Verified

January 1, 2024

Enrollment Period

2 months

First QC Date

December 19, 2023

Last Update Submit

January 18, 2024

Conditions

Keywords

TransidentityPreservation of fertilityParenthoodRepresentationsReproductive health

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (6)

  • number of caregivers who raise the issue of gamete reuse during their consultations.

    Up to 2 months

  • number of members of the healthcare team who have changed their practice since the service began accepting transgender patients

    Up to 2 months

  • Number of patients who have developed a parental project following consultation with the psychologist.

    Up to 2 months

  • Number of patients who are aware of the law and their rights in terms of gamete preservation and use

    Up to 2 months

  • 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

  • +1 more secondary outcomes

Study Arms (2)

Patients

Care team

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

For patient : transgender patients consulting as part of a fertility preservation course For care teams : care teams from the biology and reproductive medicine department

You may qualify if:

  • 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

You may not qualify if:

  • No social security
  • Persons under guardianship

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

CECOS / service de Biologie de la Reproduction Hôpital Tenon

Paris, 75020, France

Location

MeSH Terms

Conditions

TranssexualismInfertility

Condition Hierarchy (Ancestors)

SexualitySexual BehaviorBehaviorGenital DiseasesUrogenital Diseases

Study Officials

  • Emilie MOREAU

    Assistance Publique - Hôpitaux de Paris

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 19, 2023

First Posted

January 23, 2024

Study Start

February 1, 2024

Primary Completion

April 1, 2024

Study Completion

April 1, 2024

Last Updated

January 23, 2024

Record last verified: 2024-01

Data Sharing

IPD Sharing
Will not share

Locations