The Determinants of Fertility Preservation in TRANSgender Patients.

NCT ID: NCT06074796

Last Updated: 2024-03-26

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Total Enrollment

230 participants

Study Classification

OBSERVATIONAL

Study Start Date

2023-09-25

Study Completion Date

2024-04-30

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Fertility Preservation Transgender Transgenderism

Study Design

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Observational Model Type

COHORT

Study Time Perspective

RETROSPECTIVE

Study Groups

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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.

No intervention.

Intervention Type BEHAVIORAL

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.

Interventions

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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.

Intervention Type BEHAVIORAL

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Central Hospital, Nancy, France

OTHER

Sponsor Role lead

Responsible Party

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Mikael AGOPIANTZ

head of the ART center, Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Mikael AGOPIANTZ, PHD MCU

Role: PRINCIPAL_INVESTIGATOR

CentralHNF Nancy Regional University Hospital

Locations

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Centre AMP Maternité Régionale de Nancy

Nancy, , France

Site Status RECRUITING

Countries

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France

Central Contacts

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Mikael Agopiantz Agopiantz, PHD

Role: CONTACT

0033671038224

Mikael Agopiantz, PHD

Role: CONTACT

0033671038224

Facility Contacts

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Mikael AGOPIANTZ, PHD MCU

Role: primary

0383344426

References

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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.

Reference Type BACKGROUND
PMID: 35309678 (View on PubMed)

Other Identifiers

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2023PI127-413

Identifier Type: -

Identifier Source: org_study_id

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