The Determinants of Fertility Preservation in TRANSgender Patients.
FP-TRANS
1 other identifier
observational
230
1 country
1
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
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Sep 2023
Shorter than P25 for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
September 25, 2023
CompletedFirst Submitted
Initial submission to the registry
October 4, 2023
CompletedFirst Posted
Study publicly available on registry
October 10, 2023
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 1, 2024
CompletedStudy Completion
Last participant's last visit for all outcomes
April 1, 2024
CompletedMarch 26, 2024
March 1, 2024
5 months
October 4, 2023
March 25, 2024
Conditions
Keywords
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.
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.
Eligibility Criteria
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
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
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Mikael AGOPIANTZ, PHD MCU
CentralHNF Nancy Regional University Hospital
Central Study Contacts
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