- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06530992
The Effect of Tucking on Semen Quality of Adult Trans Women
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.
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 Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Estimated)
Contacts and Locations
Study Contact
- Name: Katharina Feil, MD
- Phone Number: +4351250425657
- Email: katharina.feil@i-med.ac.at
Study Locations
-
-
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Innsbruck, Austria
- Recruiting
- University clinic for Gynecological Endocrinology and Reproductive Medicine Department of Gynecology Medical University of Innsbruck
-
Contact:
- Katharina Feil, MD
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
Accepts Healthy Volunteers
Sampling Method
Study Population
Description
Inclusion Criteria:
- 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
Exclusion Criteria:
- Ongoing GAHT gender affirming genital surgery Hypogonadism Diabetes mellitus Cystic Fibrosis Varicocele Cryptorchism Post-sterilization Incapacity to consent
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
|---|---|
|
tucking
trans women who practice tucking
|
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. |
|
no tucking
trans women who do not practice tucking
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
semen concentration
Time Frame: 3 months
|
Semen quality defined by semen concentration, motility and total volume with and without tucking
|
3 months
|
|
semen motility
Time Frame: 3 months
|
Semen quality defined by semen concentration, motility and total volume with and without tucking
|
3 months
|
|
semen total volume
Time Frame: 3 months
|
Semen quality defined by semen concentration, motility and total volume with and without tucking
|
3 months
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
LH
Time Frame: 3 months
|
hormone levels with and without tucking
|
3 months
|
|
FSH
Time Frame: 3 months
|
hormone levels with and without tucking
|
3 months
|
|
estradiol
Time Frame: 3 months
|
hormone levels with and without tucking
|
3 months
|
|
testosterone
Time Frame: 3 months
|
hormone levels with and without tucking
|
3 months
|
|
quality of life assessment
Time Frame: 3 months
|
measured with the questionnaire "iTransQoL"
|
3 months
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 1162/2024V2.0
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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