Fertility PreservationPaFerNCT03836027
Fertility Desires and Reproductive Needs of Transgender People
An observational study of Fertility Preservation and Parenting, run by Central Hospital, Nancy, France at 1 site in France.
Trial summary
Majority of transgender and gender nonconforming people seeking medical care are in pubertal and reproductive age. Cross-sex hormones may compromise fertility especially when preceded by puberty blocking regimen. Our current understanding on reproductive needs of transgender persons is insufficient. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Fertility Preservation, Parenting, Gender Dysphoria
- How many people
- 100 participants
- Where
- 1 siteFrance
- Study dates
- 11 Apr 2019to 6 Apr 2021
- 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
- Adult, Older adult
Study population: Participation to the study will be proposed consecutively to all subjects, fulfilling inclusion criteria, attending in-office follow-up visit for gender dysphoria in the Department of Endocrinology, Diabetology and Nutrition of the University Hospital of Nancy
Who may be able to join
- Age ≥ 18 years
- Follow-up in the Department of Endocrinology, Diabetology and Nutrition of the University Hospital of Nancy
- Gender dysphoria according to the ICD 11
- Voluntary, informed consent to participate in research
- Compulsory affiliation to the social security system
Who cannot join
- -Refusal or incapacity to be involved in the study
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Fertility Preservation and Reproductive Needs of Transgender People: Desires, Attitude and Knowledge of Subjects With Gender Dysphoria
Majority of transgender and gender nonconforming people seeking medical care are in pubertal and reproductive age. Cross-sex hormones may compromise fertility especially when preceded by puberty blocking regimen. Our current understanding on reproductive needs of transgender persons is insufficient.
The guidelines of Endocrine Society and the World Professional Association for Transgender Health prompt the health professionals to provide information on fertility risk and fertility preservation options before initiating hormonal treatment. Currently, no clear tools are available for healthcare professionals. Among several challenges for clinical care are a low clinical awareness, a lack of suitable psycho-educational instruments addressing fertility values that can be used to facilitate discussion between transgender persons and healthcare providers, a lack of established methods for fertility preservation in prepubertal youth, and a lack of long-term data regarding reproductive function, psychological and societal outcomes in this population. Likewise, current data are sparse regarding the experience of transgender and gender nonconforming people with fertility preservation.
Our aim is to describe desires, attitudes and knowledge of transgender and gender nonconforming people regarding fertility preservation wishes and reproductive needs.
- Conditions
- Fertility Preservation, Parenting, Gender Dysphoria
- Being tested
- No intervention
- Medical subject headings
- Gender Dysphoria
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
No interventionOther
No intervention
What is being measured
The primary outcome is the main question the study is designed to answer.
Reproductive desires and attitudes of transgender and gender nonconforming people towards fertility preservation
A cross-sectional anonymous survey developed in the University Hospital of Nancy. Content validity of the questionnaire is endorsed by 2 endocrinologists specialized in transgender health (EF, VP). The first part provides general information on the characteristics of respondents (9 items). The second part concerns knowledge on fertility preservation (10 items), parental desires and constraints (8 items) and attitudes on fertility preservation issues (6 items). A descriptive analysis of the sample will be done using mean and standard deviation (or median and interquartile range) for quantitative variables, and counts and percentages for qualitative variables. The approval by the Institutional Review Board of the University Hospital of Nancy and the registration at French National Commission for Data Protection and Liberties are underway.
Measured: 1 year
Secondary outcomes (5)
Knowledge of subjects with gender dysphoria on the options of fertility preservation
Description of the construct and its evaluation is detailed in the section "primary outcome measure" as follows:
A cross-sectional anonymous survey developed in the University Hospital of Nancy. Content validity of the questionnaire is endorsed by 2 endocrinologists specialized in transgender health (EF, VP). The first part provides general information on the characteristics of respondents (9 items). The second part concerns knowledge on fertility preservation (10 items), parental desires and constraints (8 items) and attitudes on fertility preservation issues (6 items). A descriptive analysis of the sample will be done using mean and standard deviation (or median and interquartile range) for quantitative variables, and counts and percentages for qualitative variables. The approval by the Institutional Review Board of the University Hospital of Nancy and the registration at French National Commission for Data Protection and Liberties are underway.
Measured: 1 year
generic quality of life: physical functioning, limitations due to physical state, pain, mental health, limitations due to mental state, social health, vitality and global health
Questionnaire (Short form 36 health survey) The SF-36 is a generic quality of life self-questionnaire with 36 items grouped in 8 dimensions (physical functioning, limitations due to physical state, pain, mental health, limitations due to mental state, social health, vitality and global health). For each dimension a quality of life score is calculated and normalized between 0 (worst possible QoL) and 100 (best QoL possible).
Measured: 1 year
Anxiety: State-Trait Anxiety Inventory, STAI-Y
- The STAI-Y assesses anxiety as a personality trait and as a specific emotional response to a situation. The first part, STAI-Y-1, consists of 20 sentences assessing the current emotional state of the subject. The second part, STAI-Y-2, consists of 20 sentences assessing the subject's usual emotional state.
- Each answer to an item in the STAI-Y is scored from 1 to 4, with 1 indicating the lowest degree of anxiety and 4 the highest degree of anxiety.
- In the STAI-Y-1, the subject indicates the intensity of his feelings on a 4-point Likert scale ranging from "not at all" to "many". In the STAI-Y-2, the subject indicates on a 4-point Likert scale ranging from "almost never" to "almost always", a frequency at which he usually feels the symptoms listed.
- To obtain the score for the STAI-Y-1, the scores for the 20 items (1 to 20) are summed. To obtain the STAI-Y-2 score, the scores for the 20 items (21 to 40) are summed. Each score can therefore vary from 20 to 80.
Measured: 1 year
Self-esteem : Physical self inventory, 25 items (PSI-25)
- The PSI-25 is an inventory of self-esteem relating to the body domain.
- This tool consists of 6 scales: at the general level, the overall self-esteem scale, at the physical domain level: the perceived physical value scale, and at the subdomain level, 4 subscales: the fitness, athletic competence, physical appearance and strength. It has 25 items
- The subject responds on the Likert scale in 6 increasing degrees (it looks like me 1: not at all, 2: very little, 3: a little, 4: enough, 5: a lot, 6: quite).
- The score ranges from 5 to 30 for each scale, total score is averaged.
Measured: 1 year
Depression: Center for Epidemiologic Studies Depression Scale, CES-D
- The CES-D assesses the frequency and severity of depressive symptoms presented by the general population. The questionnaire has 20 items.
- The subject indicates on a 4-point Likert scale ranging from "almost never" to "almost always", a frequency at which he usually feels the symptoms listed.
- Score is calculated from 0 to 60 (maximum score indicating strong expression of symptoms)
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Feb 2019
- Study start11 Apr 2019
- Primary completion6 Apr 2021
- Study completion6 Apr 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- Prospective
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- Central Hospital, Nancy, France
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03836027
- Sponsor's protocol ID
- 2018-A03374-51
- Acronym
- PaFer
- Status last verified
- Jul 2020
- First submitted
- 28 Jan 2019
- Last updated
- 9 Feb 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 9 Feb 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Fertility Preservation and Reproductive Needs of Transgender People: Desires, Attitude and Knowledge of Subjects With Gender Dysphoria
- ClinicalTrials.gov ID
- NCT03836027
- Acronym / sponsor ID
- PaFer / 2018-A03374-51
- Conditions
- Fertility Preservation, Parenting, Gender Dysphoria
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- Central Hospital, Nancy, FranceUniversity, hospital or other
- Study start
- 11 Apr 2019 (actual)
- Primary completion
- 6 Apr 2021 (actual)
- Study completion
- 6 Apr 2021 (actual)
- First posted
- 11 Feb 2019 (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.
Majority of transgender and gender nonconforming people seeking medical care are in pubertal and reproductive age. Cross-sex hormones may compromise fertility especially when preceded by puberty blocking regimen. Our current understanding on reproductive needs of transgender persons is insufficient.
The guidelines of Endocrine Society and the World Professional Association for Transgender Health prompt the health professionals to provide information on fertility risk and fertility preservation options before initiating hormonal treatment. Currently, no clear tools are available for healthcare professionals. Among several challenges for clinical care are a low clinical awareness, a lack of suitable psycho-educational instruments addressing fertility values that can be used to facilitate discussion between transgender persons and healthcare providers, a lack of established methods for fertility preservation in prepubertal youth, and a lack of long-term data regarding reproductive function, psychological and societal outcomes in this population. Likewise, current data are sparse regarding the experience of transgender and gender nonconforming people with fertility preservation.
Our aim is to describe desires, attitudes and knowledge of transgender and gender nonconforming people regarding fertility preservation wishes and reproductive needs.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- Participation to the study will be proposed consecutively to all subjects, fulfilling inclusion criteria, attending in-office follow-up visit for gender dysphoria in the Department of Endocrinology, Diabetology and Nutrition of the University Hospital of Nancy
Key inclusion criteria (5 listed)
- Age ≥ 18 years
- Follow-up in the Department of Endocrinology, Diabetology and Nutrition of the University Hospital of Nancy
- Gender dysphoria according to the ICD 11
- Voluntary, informed consent to participate in research
- Compulsory affiliation to the social security system
Key exclusion criteria (1 listed)
- -Refusal or incapacity to be involved in the study
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 interventionNo intervention | Other | – |
Primary outcome
Reproductive desires and attitudes of transgender and gender nonconforming people towards fertility preservation
Time frame: 1 year
A cross-sectional anonymous survey developed in the University Hospital of Nancy. Content validity of the questionnaire is endorsed by 2 endocrinologists specialized in transgender health (EF, VP). The first part provides general information on the characteristics of respondents (9 items). The second part concerns knowledge on fertility preservation (10 items), parental desires and constraints (8 items) and attitudes on fertility preservation issues (6 items). A descriptive analysis of the sample will be done using mean and standard deviation (or median and interquartile range) for quantitative variables, and counts and percentages for qualitative variables. The approval by the Institutional Review Board of the University Hospital of Nancy and the registration at French National Commission for Data Protection and Liberties are underway.
5 secondary outcomes
Knowledge of subjects with gender dysphoria on the options of fertility preservation
Time frame: 1 year
generic quality of life: physical functioning, limitations due to physical state, pain, mental health, limitations due to mental state, social health, vitality and global health
Time frame: 1 year
Anxiety: State-Trait Anxiety Inventory, STAI-Y
Time frame: 1 year
Self-esteem : Physical self inventory, 25 items (PSI-25)
Time frame: 1 year
Depression: Center for Epidemiologic Studies Depression Scale, CES-D
Time frame: 1 year
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Feb 2022.
- Individual participant dataSharing planned: Yes
Related trials for Fertility Preservation
Active, not recruiting
Ovarian Tissue Cryopreservation in Children
Cancer
Not yet recruitingObservational study
Perceptions and Acceptance of Grafting of Cryopreserved Testicular Tissue
Fertility, Testicular Tissue Cryopreserved
RecruitingObservational study
Gonadal Tissue Freezing for Fertility Preservation in Individuals at Risk for Ovarian Dysfunction, Premature Ovarian Insufficiency and Clinically Indicated Gonadectomy
Turner Syndrome, Post-menarcheal Adolescents
RecruitingObservational study
Follicular Flushing Versus Direct Aspiration in Transabdominal Oocyte Retrieval
Fertility Preservation
Recruiting
Investigating the Efficacy of a Paediatric Fertility Preservation Decision Aid in Parents and Adolescents and Young Adults (CAYA) Cancer Survivors
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.
The record lists no contact. Use the official record to reach the sponsor.
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 Parenting, 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 5 inclusion and 1 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: finished, as of the sponsor's last update on 9 Feb 2022. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Reproductive desires and attitudes of transgender and gender nonconforming people towards fertility preservation (time frame: 1 year). 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 9 Feb 2022.