An observational study in Transgender, Gender Incongruence and Fertility Issues, sponsored by Medical University Innsbruck. Recruiting at 1 site in Austria. Open to male participants aged 18 Years to 50 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2024-07-31.
Sponsored by Medical University Innsbruck · Observational
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.
2,506 studies on the registry are indexed under Infertility; 407 are open to participants now.
This study's planned enrollment of 40 is below the median of 200 across 714 observational studies indexed under Infertility.
Browse Infertility studies →Medical University Innsbruck is the lead sponsor of 182 studies on the registry; 49 are open to participants now.
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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:
trans women who practice tucking
Other: tucking break
trans women who do not 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.
semen concentration
Semen quality defined by semen concentration, motility and total volume with and without tucking
Time frame: 3 months
semen motility
Semen quality defined by semen concentration, motility and total volume with and without tucking
Time frame: 3 months
semen total volume
Semen quality defined by semen concentration, motility and total volume with and without tucking
Time frame: 3 months
LH
hormone levels with and without tucking
Time frame: 3 months
FSH
hormone levels with and without tucking
Time frame: 3 months
estradiol
hormone levels with and without tucking
Time frame: 3 months
testosterone
hormone levels with and without tucking
Time frame: 3 months
quality of life assessment
measured with the questionnaire "iTransQoL"
Time frame: 3 months
Plan to share: Undecided
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Medical University Innsbruck