NCT06074796

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.

Trial Health

57
Monitor

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
230

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Sep 2023

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
recruiting

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

Study Start

First participant enrolled

September 25, 2023

Completed
9 days until next milestone

First Submitted

Initial submission to the registry

October 4, 2023

Completed
6 days until next milestone

First Posted

Study publicly available on registry

October 10, 2023

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2024

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2024

Completed
Last Updated

March 26, 2024

Status Verified

March 1, 2024

Enrollment Period

5 months

First QC Date

October 4, 2023

Last Update Submit

March 25, 2024

Conditions

Keywords

transgenderfertility preservationparenthoodsocial determinants

Outcome Measures

Primary Outcomes (1)

  • 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.

Study Arms (1)

Transgender patients

Patients included are transgender patients who have had routine consultations as part of the transition process for transgender patients, done in the reproductive medicine department of the regional university hospital centre in Nancy. Exclusion criteria : minors, patients under guardianship or trusteeship. French laws allow embryo transfer until 45 years for women and sperm reuse up to 60 years for men, so patients older have been excluded.

Behavioral: No intervention.

Interventions

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.

Transgender patients

Eligibility Criteria

Age18 Years - 60 Years
Sexall(Gender-based eligibility)
Gender Eligibility Detailstransgender patients
Healthy VolunteersNo
Age GroupsAdult (18-64)
Sampling MethodNon-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.

You may qualify if:

  • 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.

You may not qualify if:

  • minors
  • patients under guardianship or under tutelage

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Centre AMP Maternité Régionale de Nancy

Nancy, 54000, France

RECRUITING

Related 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.

    PMID: 35309678BACKGROUND

MeSH Terms

Conditions

Transsexualism

Condition Hierarchy (Ancestors)

SexualitySexual BehaviorBehavior

Study Officials

  • Mikael AGOPIANTZ, PHD MCU

    CentralHNF Nancy Regional University Hospital

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Mikael Agopiantz Agopiantz, PHD

CONTACT

Mikael Agopiantz, PHD

CONTACT

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
head of the ART center, Principal Investigator

Study Record Dates

First Submitted

October 4, 2023

First Posted

October 10, 2023

Study Start

September 25, 2023

Primary Completion

March 1, 2024

Study Completion

April 1, 2024

Last Updated

March 26, 2024

Record last verified: 2024-03

Data Sharing

IPD Sharing
Will not share

Locations