Fertility PreservationFP-TRANSNCT06074796
The Determinants of Fertility Preservation in TRANSgender Patients.
An observational study of Fertility Preservation and Transgender, run by Central Hospital, Nancy, France at 1 site in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Fertility Preservation, Transgender, Transgenderism
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 230 participants
- Where
- 1 siteFrance
- Study dates
- 25 Sep 2023to Apr 2024
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 60 years
- All sexes
- No healthy volunteers
- Adult
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.
Who may be able to join
- 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.
Who cannot join
- minors
- patients under guardianship or under tutelage
Trial locations and contacts
1 site in 1 country.
France1 site, 1 recruiting
- Recruiting
Centre AMP Maternité Régionale de Nancy
Nancy, 54000
Mikael AGOPIANTZ, PHD MCU, 0383344426, m.agopiantz@chru-nancy.fr
Mikael AGOPIANTZ, PHD MCU
About this study
Official title: The Determinants of Fertility Preservation in TRANSgender Patients (FP-TRANS).
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.
Read more
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.
Read the detailed description
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
- Fertility Preservation, Transgender, Transgenderism
- Being tested
- No intervention.
- Keywords
- transgender, fertility preservation, parenthood, social determinants
- Medical subject headings
- Transsexualism
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
No intervention.Behavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Behavioral: No intervention. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Statistiques Will be done by December 2023.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Oct 2023
- Study start25 Sep 2023
- Primary completionMar 2024 (estimated)
- Study completionApr 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Fertility PreservationStudies of the same condition, open and under way.
- More trials run by Central Hospital, Nancy, FranceThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 230 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Central Hospital, Nancy, France
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mikael AGOPIANTZ, Central Hospital, Nancy, France
- Investigators
- Mikael AGOPIANTZ, PHD MCU, Principal investigator, CentralHNF Nancy Regional University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06074796
- Sponsor's protocol ID
- 2023PI127-413
- Acronym
- FP-TRANS
- Status last verified
- Mar 2024
- First submitted
- 4 Oct 2023
- Last updated
- 26 Mar 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 35309678
Study at a glance
From the registry record, last updated by the sponsor on 26 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Determinants of Fertility Preservation in TRANSgender Patients (FP-TRANS).
- ClinicalTrials.gov ID
- NCT06074796
- Acronym / sponsor ID
- FP-TRANS / 2023PI127-413
- Conditions
- Fertility Preservation, Transgender, Transgenderism
- Keywords
- transgender, fertility preservation, parenthood, social determinants
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 230 participants (estimated)
- Lead sponsor
- Central Hospital, Nancy, FranceUniversity, hospital or other
- Study start
- 25 Sep 2023 (actual)
- Primary completion
- Mar 2024 (estimated)
- Study completion
- Apr 2024 (estimated)
- First posted
- 10 Oct 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
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.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Transgender patients | – | Behavioral: No intervention.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. |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
- 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.
Key inclusion criteria (1 listed)
- 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.
Key exclusion criteria (2 listed)
- minors
- patients under guardianship or under tutelage
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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. | Behavioural | Transgender patients |
Primary outcome
significant result p < 0.05 of qualitative and quantitative data
Time frame: Statistiques Will be done by December 2023.
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.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Mar 2024.
- Background: PubMed 35309678Mattelin 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.
- Individual participant dataSharing planned: No
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Unmet Fertility Information Needs
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Mikael AGOPIANTZ, PHD MCU principal investigator
CentralHNF Nancy Regional University Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Fertility Preservation and Transgender, run by Central Hospital, Nancy, France at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 26 Mar 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Mikael Agopiantz Agopiantz, PHD (0033671038224, mikael.agopiantz@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
significant result p < 0.05 of qualitative and quantitative data (time frame: Statistiques Will be done by December 2023.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06074796, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Mar 2024.