Ignite Creation Date:
2024-10-25 @ 8:03 PM
Last Modification Date:
2024-10-26 @ 3:36 PM
Study NCT ID:
NCT06530992
Status:
RECRUITING
Last Update Posted:
None
First Post:
2024-07-23
Brief Title:
The Effect of Tucking on Semen Quality of Adult Trans Women
Sponsor:
None
Organization:
None
Study Overview
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
Status:
RECRUITING
Status Verified Date:
2024-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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 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 millml 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 participants 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
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 participants 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
Detailed Description:
None
Study Oversight
Has Oversight DMC:
Is a FDA Regulated Drug?:
Is a FDA Regulated Device?:
Is an Unapproved Device?:
Is a PPSD?:
Is a US Export?:
Is an FDA AA801 Violation?: