Ignite Creation Date:
2024-10-26 @ 3:35 PM
Last Modification Date:
2024-10-26 @ 3:35 PM
Study NCT ID:
NCT06518746
Status:
RECRUITING
Last Update Posted:
None
First Post:
2024-07-03
Brief Title:
Gonadal Dysgenesis Tissue Cryopreservation for Fertility Preservation
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Gonadal Dysgenesis Tissue Cryopreservation for Fertility Preservation
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:
The Gonadal Dysgenesis Tissue Cryopreservation for Fertility Preservation study is open to a subset of patients with disorders of sex development DSD which is associated with the risk of malignancy and a high risk of infertility or sterility For these patients experimental gonadal tissue cryopreservation is the only fertility preservation option available The overall objective of this study is to determine the safety and efficacy of gonadal tissue cryopreservation as a method of preserving fertility andor restoring hormonal function in patients with gonadal dysgenesis who are at risk of decreased fertility potential or malignancy
Detailed Description:
Unlike the oncology population in which patients have inherently normal fertility potential and reproductive function individuals with DSD may have infertility caused by 1 abnormal gonadal development 2 gonadectomy performed for risk of malignancy 3 abnormal hormone production or 4 discordance or difference between gonadal type and gender identity Fertility potential differs according to the specific DSD diagnosis and can also be influenced by age genetic mosaicism andor risk of developing a gonadal malignancy
Abnormal gonadal development can result in gonadal failure either in infancy or progressively such that individuals may not undergo spontaneous puberty menarche or spermarche Progressive germ cell loss may occur throughout childhood In addition abnormal gonadal development in certain cellular environments leads to an increased risk of germ cell cancer Traditionally it was recommended to perform gonadectomy at the time of diagnosis in all DSD conditions with a risk of gonadal tumor formation The estimated tumor risk ranges from 2 in complete androgen insensitivity syndrome to 40 in partial androgen insensitivity syndrome Advances in stratification of tumor risk have led to a more diagnosis-specific assessment of risk but tumor risk remains a major concern
Thus the investigators are conducting a pilot study to assess the safety and efficacy of gonadal tissue cryopreservation as a method of preserving fertility andor restoring hormonal function in patients with gonadal dysgenesis who are at risk of decreased fertility potential or malignancy
Abnormal gonadal development can result in gonadal failure either in infancy or progressively such that individuals may not undergo spontaneous puberty menarche or spermarche Progressive germ cell loss may occur throughout childhood In addition abnormal gonadal development in certain cellular environments leads to an increased risk of germ cell cancer Traditionally it was recommended to perform gonadectomy at the time of diagnosis in all DSD conditions with a risk of gonadal tumor formation The estimated tumor risk ranges from 2 in complete androgen insensitivity syndrome to 40 in partial androgen insensitivity syndrome Advances in stratification of tumor risk have led to a more diagnosis-specific assessment of risk but tumor risk remains a major concern
Thus the investigators are conducting a pilot study to assess the safety and efficacy of gonadal tissue cryopreservation as a method of preserving fertility andor restoring hormonal function in patients with gonadal dysgenesis who are at risk of decreased fertility potential or malignancy
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None