Ignite Creation Date:
2024-05-06 @ 6:53 PM
Last Modification Date:
2024-10-26 @ 2:57 PM
Study NCT ID:
NCT05829928
Status:
RECRUITING
Last Update Posted:
2024-03-05
First Post:
2023-04-13
Brief Title:
Testicular Tissue Cryopreservation in the Setting of Gender-Affirming Therapy
Sponsor:
University of Pittsburgh
Organization:
University of Pittsburgh
Study Overview
Official Title:
Testicular Tissue Cryopreservation in the Setting of Gender-Affirming Therapy
Status:
RECRUITING
Status Verified Date:
2024-03
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The goal of this study is to learn about fertility preservation in the gender-diverse community The main objectives it aims to understand are to
1 Optimize techniques for processing and cryopreserving testicular tissue
2 Determine presence and number of germ cells sperm precursors in the patients testicular tissue
3 Develop next generation cell- and tissue-based therapies for preserving fertility and treating infertility
1 Optimize techniques for processing and cryopreserving testicular tissue
2 Determine presence and number of germ cells sperm precursors in the patients testicular tissue
3 Develop next generation cell- and tissue-based therapies for preserving fertility and treating infertility
Detailed Description:
Fertility preservation is an important aspect of care for all patients who may have their fertility compromised secondary to disease medical treatments age or other circumstances including treatments for gender dysphoria An increasing number of gender diverse patients are presenting to fertility clinics for fertility preservation Studies indicate that parenthood is important for this patient population Therefore both the Endocrine Society and the World Professional Association for Transgender Health WPATH recommend that fertility preservation be discussed with all patients prior to initiation of medical treatments for gender dysphoria
For gender diverse patients medical treatment is primarily comprised of estradiol which is often preceded by GnRH agonists such as leuprolide acetate histrelin to reduce endogenous testosterone production There are theoretical concerns about the effects of long-standing hormonal treatment on the gonads and future fertility potential Regardless of the timing of initiation of hormone suppression andor estradiol therapy fertility preservation counseling is an essential aspect of their care Sperm preservation does require the individual to undergo their natal puberty and for many transgender patients this is undesirable and even contra-indicated from mental health standpoint as the suicide rate for transgender youth is 10-times the national average Testicular tissue cryopreservation is an alternative option for transgender patients who desire pubertal blockade and estradiol but have not yet initiated sperm production spermarche to preserve their fertility Spermarche typically occurs at sexual maturity rating SMR 4 and pubertal blockade is offered as early as SMR 2
For gender diverse patients medical treatment is primarily comprised of estradiol which is often preceded by GnRH agonists such as leuprolide acetate histrelin to reduce endogenous testosterone production There are theoretical concerns about the effects of long-standing hormonal treatment on the gonads and future fertility potential Regardless of the timing of initiation of hormone suppression andor estradiol therapy fertility preservation counseling is an essential aspect of their care Sperm preservation does require the individual to undergo their natal puberty and for many transgender patients this is undesirable and even contra-indicated from mental health standpoint as the suicide rate for transgender youth is 10-times the national average Testicular tissue cryopreservation is an alternative option for transgender patients who desire pubertal blockade and estradiol but have not yet initiated sperm production spermarche to preserve their fertility Spermarche typically occurs at sexual maturity rating SMR 4 and pubertal blockade is offered as early as SMR 2
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None