PregnancyNCT06710496
HISTOLOGICAL RESULTS IN TRANSGENDER INDIVIDUALS ASSIGNED TO FEMALES AT BIRTH UNDERGOING GENDER AFFIRMATION SURGERY AND IN TESTOSTERONE THERAPY
An observational study of Pregnancy and Smoking Behavior, run by IRCCS Azienda Ospedaliero-Universitaria di Bologna at 1 site in Italy.
Trial summary
The aim of this study is to report histological results of genital organs removed during gender affirmg surgery in transgender people assigned female at birth (AFAB), to increase the knowledge about the long-term effects of gender affirming hormone therapy with testosterone on these organs and to evaluate the… Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Pregnancy, Smoking Behavior, Testosterone Replacement Therapy
- What is being tested?
- analysis of medical records
- How many people
- 100 participants
- Where
- 1 siteItaly
- Study dates
- Dec 2024to Dec 2025
- 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
- Women only
- No healthy volunteers
- Adult, Older adult
Study population: transgender people assigned female at birth undergoing gender affirming surgery with hysterectomy and on testosterone therapy
Who may be able to join
- gender incongruence diagnosis
- people assigned female at birth
- age >18 years
- gender affirming surgery with hysterectomy
- testosterone therapy
Who cannot join
- previous gynecological surgery
- previous gynecological disorder diagnosis
Trial locations and contacts
1 site in 1 country.
Italy1 site
irccs azienda ospedaliero universitaria di Bologna
Bologna, Emilia-Romagna, 40138
Alessandra Lami, PhD Student, +393343097975, alessandra.lami@studio.unibo.it
About this study
The aim of this study is to report histological results of genital organs removed during gender affirmg surgery in transgender people assigned female at birth (AFAB), to increase the knowledge about the long-term effects of gender affirming hormone therapy with testosterone on these organs and to evaluate the incidence of benign and malign gynecological pathology in AFAB transgender people.
Read the detailed description
This retrospective, observational, single-center study aims to analyze histological data obtained from the analysis of ovaries, fallopian tubes, uterine body, endometrium, and cervix of assigned female at birth (AFAB) transgender individuals who underwent gender affirming surgey (GAS) with hysterectomy and bilateral adnexectomy or hysterectomy alone following the administration of exogenous Testosterone (T). Histological results of the genital organs removed during GAS can provide important information about the effects and safety of loong term T treatment on these organs. Data on this subject is scarce in the literature. For this reason, even today, pathologists have not been able to establish guidelines for describing the histological results obtained from these patients.Furthermore, this analysis will evaluate the incidence of benign and malignant gynecological pathology in AFAB transgender people.
- Conditions
- Pregnancy, Smoking Behavior, Testosterone Replacement Therapy, Drugs, Comorbidities and Coexisting Conditions, Gynecological Surgery
- Being tested
- analysis of medical records
- Keywords
- transgender, afab, histology
- Medical subject headings
- Smoking, Genital Diseases, Female
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
analysis of medical recordsOther
analysis of medical records of the patients
| Study group | Role | What they receive |
|---|---|---|
| AFAB TG | assigned female at birth transgender people undergoing gender affirming surgery during testosterone therapy Receives: Other: analysis of medical records |
What is being measured
The primary outcome is the main question the study is designed to answer.
histological description of genital organs
Measured: 6 months
Secondary outcomes (1)
prevalence of malignant and benign gynecological pathology
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Nov 2024
- Study startDec 2024 (estimated)
- Primary completionFeb 2025 (estimated)
- Study completionDec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PregnancyStudies of the same condition, open and under way.
- More trials run by IRCCS Azienda Ospedaliero-Universitaria di BolognaThe 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
- Other
- Time perspective
- Retrospective
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Maria Cristina Meriggiola, IRCCS Azienda Ospedaliero-Universitaria di Bologna
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06710496
- Sponsor's protocol ID
- ISTO-AFAB
- Status last verified
- Sep 2024
- First submitted
- 26 Nov 2024
- Last updated
- 29 Nov 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Nov 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- HISTOLOGICAL RESULTS IN TRANSGENDER INDIVIDUALS ASSIGNED TO FEMALES AT BIRTH UNDERGOING GENDER AFFIRMATION SURGERY AND IN TESTOSTERONE THERAPY
- ClinicalTrials.gov ID
- NCT06710496
- Acronym / sponsor ID
- ISTO-AFAB
- Conditions
- Pregnancy, Smoking Behavior, Testosterone Replacement Therapy, Drugs, Comorbidities and Coexisting Conditions, Gynecological Surgery
- Keywords
- transgender, afab, histology
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- IRCCS Azienda Ospedaliero-Universitaria di BolognaUniversity, hospital or other
- Study start
- Dec 2024 (estimated)
- Primary completion
- Feb 2025 (estimated)
- Study completion
- Dec 2025 (estimated)
- First posted
- 29 Nov 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.
The aim of this study is to report histological results of genital organs removed during gender affirmg surgery in transgender people assigned female at birth (AFAB), to increase the knowledge about the long-term effects of gender affirming hormone therapy with testosterone on these organs and to evaluate the incidence of benign and malign gynecological pathology in AFAB transgender people.
Detailed description
This retrospective, observational, single-center study aims to analyze histological data obtained from the analysis of ovaries, fallopian tubes, uterine body, endometrium, and cervix of assigned female at birth (AFAB) transgender individuals who underwent gender affirming surgey (GAS) with hysterectomy and bilateral adnexectomy or hysterectomy alone following the administration of exogenous Testosterone (T). Histological results of the genital organs removed during GAS can provide important information about the effects and safety of loong term T treatment on these organs. Data on this subject is scarce in the literature. For this reason, even today, pathologists have not been able to establish guidelines for describing the histological results obtained from these patients.Furthermore, this analysis will evaluate the incidence of benign and malignant gynecological pathology in AFAB transgender people.
Study design
- Observational model
- Other
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| AFAB TG | – | Other: analysis of medical recordsassigned female at birth transgender people undergoing gender affirming surgery during testosterone therapy |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- transgender people assigned female at birth undergoing gender affirming surgery with hysterectomy and on testosterone therapy
Key inclusion criteria (5 listed)
- gender incongruence diagnosis
- people assigned female at birth
- age >18 years
- gender affirming surgery with hysterectomy
- testosterone therapy
Key exclusion criteria (2 listed)
- previous gynecological surgery
- previous gynecological disorder diagnosis
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 |
|---|---|---|
| analysis of medical recordsanalysis of medical records of the patients | Other | AFAB TG |
Primary outcome
histological description of genital organs
Time frame: 6 months
1 secondary outcome
prevalence of malignant and benign gynecological pathology
Time frame: 6 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Nov 2024.
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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.
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 Pregnancy and Smoking Behavior, run by IRCCS Azienda Ospedaliero-Universitaria di Bologna at 1 site in Italy.
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 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 29 Nov 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 Italy. 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 Maria Cristina Meriggiola, Associate Professor (+390512144391, segreteria.meriggiola@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
histological description of genital organs (time frame: 6 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 29 Nov 2024.