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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.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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
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.

France1 site
  • University Hospital of Nancy

    Vandœuvre-lès-Nancy, 54000

Other trials in France

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.

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.

  1. 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)
  1. 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

  2. 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

  3. 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

  4. 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

  5. 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.

  1. First posted11 Feb 2019
  2. Study start11 Apr 2019
  3. Primary completion6 Apr 2021
  4. Study completion6 Apr 2021

Resources

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)
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

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.

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