TransgenderismTransFertNCT06218446
Transgender Caregivers' and Patients' Representations of Parenthood as Part of a Fertility Preservation Pathway
An observational study of Transgenderism and Fertility Issues, run by Assistance Publique - Hôpitaux de Paris at 1 site in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Transgenderism, Fertility Issues
- How many people
- 50 participants
- Where
- 1 siteFrance
- Study dates
- Feb 2024to 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 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
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
Who may be able to join
- 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
Who cannot join
- No social security
- Persons under guardianship
Trial locations and contacts
1 site in 1 country.
France1 site
CECOS / service de Biologie de la Reproduction Hôpital Tenon
Paris, 75020
Emilie MOREAU, 00 33 6 87 13 08 31, Emilie.moreau@aphp.fr
Alix BERANGER, 00 33 6 78 10 74 52, alix.beranger@aphp.fr
About this study
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.
Read more
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.
Read the detailed description
Since the 2016 law, transgender people no longer need to provide "irreversible and medical proof of a physical transformation" in order to carry out a sex change at the Civil Registry, which puts an end to systematic sterilization and opens up the possibility of a hormonal-only transition. Yet hormonal treatments can have an impact on the fertility of transgender people, compromising a subsequent project for parenthood.
The Reproductive Biology department at Tenon, where the research will take place, now offers self-conservation of female and male gametes before hormone replacement treatments are introduced, or during a therapeutic window. Fertility preservation in transgender women relies primarily on sperm self-preservation. For transgender men, fertility preservation relies on cryopreservation of mature oocytes after ovarian stimulation.
In addition to assessing the psychic impact of care in order to prevent potential deleterious effects, psycho-sexological consultation offers an opportunity to express the desire for a child, a desire often inhibited for a long time, as well as information on the possibilities of reuse.
When it comes to research around the issue of fertility preservation for transgender people, there is often talk of problems concerning access to this care: the discriminatory practices of certain centers that refuse transgender people, the lack of training in transidentity issues for care teams, etc. The coercive weight of the law seems to be enough to evade the issue by moving it into the realm of legislation. And yet, in our clinical experience, the question of gamete reuse is a subject that merits research to determine the obstacles and levers for both caregivers and patients.
- Conditions
- Transgenderism, Fertility Issues
- Keywords
- Transidentity, Preservation of fertility, Parenthood, Representations, Reproductive health
- Medical subject headings
- Transsexualism, Infertility
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Patients | Not described | |
| Care team | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Up to 2 months
Secondary outcomes (6)
number of caregivers who raise the issue of gamete reuse during their consultations.
To study the way in which caregivers perceive the possible use of preserved gametes, and how these perceptions influence their clinical practice.
Measured: Up to 2 months
number of members of the healthcare team who have changed their practice since the service began accepting transgender patients
To study the way in which caregivers perceive the possible use of preserved gametes, and how these perceptions influence their clinical practice.
criteria:
Measured: Up to 2 months
Number of patients who have developed a parental project following consultation with the psychologist.
Measured: Up to 2 months
Number of patients who are aware of the law and their rights in terms of gamete preservation and use
Measured: 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.
Measured: Up to 2 months
Number of patients for whom the intention to preserve their gametes is experienced as improving their transition path.
Measured: Up to 2 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jan 2024
- Study startFeb 2024 (estimated)
- Primary completionApr 2024 (estimated)
- Study completionApr 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for TransgenderismStudies of the same condition, open and under way.
- More trials run by Assistance Publique - Hôpitaux de ParisThe 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
- Prospective
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assistance Publique - Hôpitaux de Paris
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Emilie MOREAU, Principal investigator, Assistance Publique - Hôpitaux de Paris
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06218446
- Sponsor's protocol ID
- APHP230413
- Other IDs
- 2023-A00509-36
- Acronym
- TransFert
- Status last verified
- Jan 2024
- First submitted
- 19 Dec 2023
- Last updated
- 23 Jan 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Jan 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Transgender Caregivers' and Patients' Representations of Parenthood as Part of a Fertility Preservation Pathway
- ClinicalTrials.gov ID
- NCT06218446
- Acronym / sponsor ID
- TransFert / APHP230413
- Conditions
- Transgenderism, Fertility Issues
- Keywords
- Transidentity, Preservation of fertility, Parenthood, Representations, Reproductive health
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Assistance Publique - Hôpitaux de ParisUniversity, hospital or other
- Study start
- Feb 2024 (estimated)
- Primary completion
- Apr 2024 (estimated)
- Study completion
- Apr 2024 (estimated)
- First posted
- 23 Jan 2024 (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.
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.
Detailed description
Since the 2016 law, transgender people no longer need to provide "irreversible and medical proof of a physical transformation" in order to carry out a sex change at the Civil Registry, which puts an end to systematic sterilization and opens up the possibility of a hormonal-only transition. Yet hormonal treatments can have an impact on the fertility of transgender people, compromising a subsequent project for parenthood.
The Reproductive Biology department at Tenon, where the research will take place, now offers self-conservation of female and male gametes before hormone replacement treatments are introduced, or during a therapeutic window. Fertility preservation in transgender women relies primarily on sperm self-preservation. For transgender men, fertility preservation relies on cryopreservation of mature oocytes after ovarian stimulation.
In addition to assessing the psychic impact of care in order to prevent potential deleterious effects, psycho-sexological consultation offers an opportunity to express the desire for a child, a desire often inhibited for a long time, as well as information on the possibilities of reuse.
When it comes to research around the issue of fertility preservation for transgender people, there is often talk of problems concerning access to this care: the discriminatory practices of certain centers that refuse transgender people, the lack of training in transidentity issues for care teams, etc. The coercive weight of the law seems to be enough to evade the issue by moving it into the realm of legislation. And yet, in our clinical experience, the question of gamete reuse is a subject that merits research to determine the obstacles and levers for both caregivers and patients.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Patients | – | – |
| Care team | – | – |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- 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
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (2 listed)
- No social security
- Persons under guardianship
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Number of patients surveyed who developed or modified a gamete-use project following the fertility preservation consultation.
Time frame: Up to 2 months
To understand the impact of the fertility preservation consultation on transgender patients' projection in terms of parenthood.
6 secondary outcomes
number of caregivers who raise the issue of gamete reuse during their consultations.
Time frame: Up to 2 months
number of members of the healthcare team who have changed their practice since the service began accepting transgender patients
Time frame: Up to 2 months
Number of patients who have developed a parental project following consultation with the psychologist.
Time frame: Up to 2 months
Number of patients who are aware of the law and their rights in terms of gamete preservation and use
Time frame: 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.
Time frame: Up to 2 months
Number of patients for whom the intention to preserve their gametes is experienced as improving their transition path.
Time frame: Up to 2 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Jan 2024.
- Individual participant dataSharing planned: No
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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.
Emilie MOREAU principal investigator
Assistance Publique - Hôpitaux de Paris
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 Transgenderism and Fertility Issues, run by Assistance Publique - Hôpitaux de Paris 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 4 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 23 Jan 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 Emilie MOREAU (00 33 6 87 13 08 31, Emilie.moreau@aphp.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of patients surveyed who developed or modified a gamete-use project following the fertility preservation consultation. (time frame: Up to 2 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 23 Jan 2024.