TransgenderNCT06530992
The Effect of Tucking on Semen Quality of Adult Trans Women
An observational study of Transgender and Gender Incongruence, run by Medical University Innsbruck at 1 site in Austria.
Trial summary
Because gender-affirming hormone therapy (GAHT) can lead to fertility impairment, current guidelines and treatment recommendations require that patients be informed about the possibility of fertility preservation prior to initiating GAHT. Read more about this study
- Who is it for?
- Ages 18 to 50 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Transgender, Gender Incongruence, Fertility Issues
- What is being tested?
- tucking break
- How many people
- 40 participants
- Where
- 1 siteAustria
- Study dates
- 17 Jul 2024to Dec 2029
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 50 years
- Men only
- Healthy volunteers accepted
- Adult
Study population: Female transgender patients between the ages of 18 to 50 years of age who are seen at the University Clinic for Gyn. Endocrinology and Reproductive Medicine of the Medical University of Innsbruck. Patients must have met the eligibility and readiness criteria for gender-affirming hormone therapy.
Who may be able to join
- Female transgender patients between the ages of 18 to 50 years of age who are seen at the University Clinic for Gyn. Endocrinology and Reproductive Medicine of the Medical University of Innsbruck. Patients must have met the eligibility and readiness criteria for gender-affirming hormone therapy
Who cannot join
- Ongoing GAHT gender affirming genital surgery Hypogonadism Diabetes mellitus Cystic Fibrosis Varicocele Cryptorchism Post-sterilization Incapacity to consent
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Austria1 site, 1 recruiting
- Recruiting
University clinic for Gynecological Endocrinology and Reproductive Medicine Department of Gynecology Medical University of Innsbruck
Innsbruck
Katharina Feil, MD
About this study
Official title: The Effect of Tucking on Semen Quality of Adult Trans Women Compared to Semen Quality of Trans Women Who do Not Tuck - a Case Control Study
Because gender-affirming hormone therapy (GAHT) can lead to fertility impairment, current guidelines and treatment recommendations require that patients be informed about the possibility of fertility preservation prior to initiating GAHT. A recent review by our working group analyzed the current data on fertility and fertility preservation in transgender and gender diverse people. Several studies were identified that evaluated semen quality before and during GAHT in trans women compared to reproductive men. All studies showed a significant reduction in semen quality even before GAHT. In addition, one study found evidence that constant wearing of tight underwear and tucking was associated with a reduction in motile sperm concentration to <5 mill/ml. Tucking is a method of avoiding crotch bulge through the penis and testicles by placing the penis backwards between the legs and optionally pushing the testicles into the groin canals. These positions are fixed with tight-fitting underwear or gaffs. Whether tucking or the wearing of tight underwear is the determining factor for impaired semen quality even before the start of GAHT and whether there is reversibility remains unclear and will be investigated in the present study.
The study is designed as a prospective case-control study with a total sample size of n = 40 trans women. All patients with gender incongruence presenting to the University Clinic for Gynecology, Endocrinology and Reproduction Innsbruck before starting GAHT are eligible to participate. Trans women (n = 20) who practice tucking or wear tight underwear will be included and trans women (n = 20) who do not practice tucking will be included as a control group. At Time 1, after 2-7 days of abstinence, all participants will provide a semen sample for a spermiogram, a venous blood sample will be taken, and quality of life will be assessed using a questionnaire. The frequency and duration of tucking or wearing tight underwear, ejaculation frequency, demographic data such as BMI, nicotine use, alcohol and drug use, medication use, underlying medical conditions, previous surgeries, etc. are also recorded.
Read more
Participants in the study group are then asked to abstain tucking for at least 73 days. After 2-7 days of sperm abstinence, another semen sample is taken at time 2, a venous blood sample is taken, and quality of life is assessed. At this point, depending on the participant's wishes, there is the option of sperm cryopreservation for fertility preservation prior to starting GAHT.
Spermiograms are performed under standardized conditions according to current WHO guidelines.
- Conditions
- Transgender, Gender Incongruence, Fertility Issues
- Being tested
- tucking break
- Medical subject headings
- Gender Dysphoria, Infertility
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
tucking breakOther
All participants will provide a semen sample for sperm analysis after 2-7 days of abstinence from ejaculation, a venous blood sample will be taken at the same time, and quality of life will be assessed using a questionnaire.
Participants in the study group are then asked to refrain from tucking or wearing tight underwear for at least 73 days. At least 73 days (10.5 weeks) after the first spermiogram, another semen collection is scheduled after 2-7 days of abstinence from ejaculation for the preparation of a spermiogram, a venous blood sample is taken at the same time, and quality of life is assessed in all participants. At this point, depending on the participant's wishes, it is possible to perform sperm cryopreservation for fertility preservation before starting gender affirming hormonal treatment.
| Study group | Role | What they receive |
|---|---|---|
| tucking | trans women who practice tucking Receives: Other: tucking break | |
| no tucking | trans women who do not practice tucking |
What is being measured
The primary outcome is the main question the study is designed to answer.
semen concentration
Semen quality defined by semen concentration, motility and total volume with and without tucking
Measured: 3 months
semen motility
Semen quality defined by semen concentration, motility and total volume with and without tucking
Measured: 3 months
semen total volume
Semen quality defined by semen concentration, motility and total volume with and without tucking
Measured: 3 months
Secondary outcomes (5)
LH
hormone levels with and without tucking
Measured: 3 months
FSH
hormone levels with and without tucking
Measured: 3 months
estradiol
hormone levels with and without tucking
Measured: 3 months
testosterone
hormone levels with and without tucking
Measured: 3 months
quality of life assessment
measured with the questionnaire "iTransQoL"
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Jul 2024
- Study start17 Jul 2024
- Primary completionJul 2029 (estimated)
- Study completionDec 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for TransgenderStudies of the same condition, open and under way.
- More trials run by Medical University InnsbruckThe 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
- Case-control
- Time perspective
- Prospective
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Medical University Innsbruck
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06530992
- Sponsor's protocol ID
- 1162/2024V2.0
- Status last verified
- Jul 2024
- First submitted
- 23 Jul 2024
- Last updated
- 31 Jul 2024
- Results posted
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 31 Jul 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Tucking on Semen Quality of Adult Trans Women Compared to Semen Quality of Trans Women Who do Not Tuck - a Case Control Study
- ClinicalTrials.gov ID
- NCT06530992
- Acronym / sponsor ID
- 1162/2024V2.0
- Conditions
- Transgender, Gender Incongruence, Fertility Issues
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Medical University InnsbruckUniversity, hospital or other
- Study start
- 17 Jul 2024 (actual)
- Primary completion
- Jul 2029 (estimated)
- Study completion
- Dec 2029 (estimated)
- First posted
- 31 Jul 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.
Because gender-affirming hormone therapy (GAHT) can lead to fertility impairment, current guidelines and treatment recommendations require that patients be informed about the possibility of fertility preservation prior to initiating GAHT. A recent review by our working group analyzed the current data on fertility and fertility preservation in transgender and gender diverse people. Several studies were identified that evaluated semen quality before and during GAHT in trans women compared to reproductive men. All studies showed a significant reduction in semen quality even before GAHT. In addition, one study found evidence that constant wearing of tight underwear and tucking was associated with a reduction in motile sperm concentration to <5 mill/ml. Tucking is a method of avoiding crotch bulge through the penis and testicles by placing the penis backwards between the legs and optionally pushing the testicles into the groin canals. These positions are fixed with tight-fitting underwear or gaffs. Whether tucking or the wearing of tight underwear is the determining factor for impaired semen quality even before the start of GAHT and whether there is reversibility remains unclear and will be investigated in the present study.
The study is designed as a prospective case-control study with a total sample size of n = 40 trans women. All patients with gender incongruence presenting to the University Clinic for Gynecology, Endocrinology and Reproduction Innsbruck before starting GAHT are eligible to participate. Trans women (n = 20) who practice tucking or wear tight underwear will be included and trans women (n = 20) who do not practice tucking will be included as a control group. At Time 1, after 2-7 days of abstinence, all participants will provide a semen sample for a spermiogram, a venous blood sample will be taken, and quality of life will be assessed using a questionnaire. The frequency and duration of tucking or wearing tight underwear, ejaculation frequency, demographic data such as BMI, nicotine use, alcohol and drug use, medication use, underlying medical conditions, previous surgeries, etc. are also recorded.
Participants in the study group are then asked to abstain tucking for at least 73 days. After 2-7 days of sperm abstinence, another semen sample is taken at time 2, a venous blood sample is taken, and quality of life is assessed. At this point, depending on the participant's wishes, there is the option of sperm cryopreservation for fertility preservation prior to starting GAHT.
Spermiograms are performed under standardized conditions according to current WHO guidelines.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| tucking | – | Other: tucking breaktrans women who practice tucking |
| no tucking | – | –trans women who do not practice tucking |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- Female transgender patients between the ages of 18 to 50 years of age who are seen at the University Clinic for Gyn. Endocrinology and Reproductive Medicine of the Medical University of Innsbruck. Patients must have met the eligibility and readiness criteria for gender-affirming hormone therapy.
Key inclusion criteria (1 listed)
- Female transgender patients between the ages of 18 to 50 years of age who are seen at the University Clinic for Gyn. Endocrinology and Reproductive Medicine of the Medical University of Innsbruck. Patients must have met the eligibility and readiness criteria for gender-affirming hormone therapy
Key exclusion criteria (1 listed)
- Ongoing GAHT gender affirming genital surgery Hypogonadism Diabetes mellitus Cystic Fibrosis Varicocele Cryptorchism Post-sterilization Incapacity to consent
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 |
|---|---|---|
| tucking breakAll participants will provide a semen sample for sperm analysis after 2-7 days of abstinence from ejaculation, a venous blood sample will be taken at the same time, and quality of life will be assessed using a questionnaire. Participants in the study group are then asked to refrain from tucking or wearing tight underwear for at least 73 days. At least 73 days (10.5 weeks) after the first spermiogram, another semen collection is scheduled after 2-7 days of abstinence from ejaculation for the preparation of a spermiogram, a venous blood sample is taken at the same time, and quality of life is assessed in all participants. At this point, depending on the participant's wishes, it is possible to perform sperm cryopreservation for fertility preservation before starting gender affirming hormonal treatment. | Other | tucking |
Primary outcome
semen concentration
Time frame: 3 months
Semen quality defined by semen concentration, motility and total volume with and without tucking
semen motility
Time frame: 3 months
Semen quality defined by semen concentration, motility and total volume with and without tucking
semen total volume
Time frame: 3 months
Semen quality defined by semen concentration, motility and total volume with and without tucking
5 secondary outcomes
LH
Time frame: 3 months
FSH
Time frame: 3 months
estradiol
Time frame: 3 months
testosterone
Time frame: 3 months
quality of life assessment
Time frame: 3 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Jul 2024.
- Individual participant dataSharing planned: Undecided
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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.
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 Transgender and Gender Incongruence, run by Medical University Innsbruck at 1 site in Austria.
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 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: looking for participants now, as of the sponsor's last update on 31 Jul 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 Austria. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Katharina Feil, MD (+4351250425657, katharina.feil@i-med.ac.at), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
semen concentration (time frame: 3 months). The study lists 3 primary outcomes in all. 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 31 Jul 2024.