Ignite Creation Date:
2024-05-06 @ 2:24 PM
Last Modification Date:
2024-10-26 @ 1:30 PM
Study NCT ID:
NCT04308486
Status:
UNKNOWN
Last Update Posted:
2020-03-16
First Post:
2020-03-10
Brief Title:
Anti-mullerian HormoneTestesteroneEsrtadiolTestesteroneEsrtadiol Ratio as Predictive Values for TESA and TESE Outcome in Non Obstructive Azoospermia
Sponsor:
Assiut University
Organization:
Assiut University
Study Overview
Official Title:
Anti-mullerian HormoneTestesteroneEsrtadiolTestesteroneEsrtadiol Ratio as Predictive Values for TESA and TESE Outcome in Non Obstructive Azoospermia
Status:
UNKNOWN
Status Verified Date:
2020-03
Last Known Status:
NOT_YET_RECRUITING
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:
Evaluate the predictive value of AMH TestosteroneEstradiolTestosterone Estradiol ratio for TESA and TESE outcome in non obstructive azoospermic patients
Detailed Description:
The relevance of male infertility has progressively grown with significant medical psychological and socio-economic implications With no sperm found at multiple semen analyses non-obstructive azoospermia NOA is the most severe form of infertility
The introduction to clinical practice of assisted reproduction techniques such as intra-cytoplasmic sperm injection ICSI made fatherhood possible for men with NOA The extraction of sperm from the testis through testicular sperm aspiration TESA testicular sperm extraction TESE or open biopsy can result in a favorable reproductive outcome Nevertheless all these procedures are invasive in nature with variable possibility of successful sperm extraction As a consequence a non-invasive test that could predict the presence of sperm in men with NOA would be of profound clinical importance
However the lack of useful predictive biomarkers suggestive for successful sperm retrieval at microTESE and TESA in NOA men still represents a relevant gap with a very negative return for the patient Indeed no significant association has been found between microTESEand TESA sperm retrieval outcomes and preoperative testicular volume baseline follicular stimulating hormone FSH levels basal level of Testosterone T or increased T level following treatments with aromatase inhibitors clomiphene citrate or human chorionic gonadotropin
Therefore it has been amust to identify novel and user-friendly prognostic factors reliably predicting surgical outcomes in NOA men in the real-life setting Among other variables some hormons can be subjected to studies for this purpose such as levels of testis-derived hormones which might be representative of the primary testicular failure as the Anti-Müllerian Hormone AMH which is suggestive for a Sertoli cells immature phenotypeand testosterone of biological relevance
An investigation from the early 1970s demonstrated that the human testis does indeed secrete estradiol within the spermatic vein at amean concentration that is 50 times greater than that inthe peripheral plasma These findings led to the hypothesis that local estrogen levels might be associated with the current stateof spermatogenesis or the total number of spermatogenic cells in the testis
The introduction to clinical practice of assisted reproduction techniques such as intra-cytoplasmic sperm injection ICSI made fatherhood possible for men with NOA The extraction of sperm from the testis through testicular sperm aspiration TESA testicular sperm extraction TESE or open biopsy can result in a favorable reproductive outcome Nevertheless all these procedures are invasive in nature with variable possibility of successful sperm extraction As a consequence a non-invasive test that could predict the presence of sperm in men with NOA would be of profound clinical importance
However the lack of useful predictive biomarkers suggestive for successful sperm retrieval at microTESE and TESA in NOA men still represents a relevant gap with a very negative return for the patient Indeed no significant association has been found between microTESEand TESA sperm retrieval outcomes and preoperative testicular volume baseline follicular stimulating hormone FSH levels basal level of Testosterone T or increased T level following treatments with aromatase inhibitors clomiphene citrate or human chorionic gonadotropin
Therefore it has been amust to identify novel and user-friendly prognostic factors reliably predicting surgical outcomes in NOA men in the real-life setting Among other variables some hormons can be subjected to studies for this purpose such as levels of testis-derived hormones which might be representative of the primary testicular failure as the Anti-Müllerian Hormone AMH which is suggestive for a Sertoli cells immature phenotypeand testosterone of biological relevance
An investigation from the early 1970s demonstrated that the human testis does indeed secrete estradiol within the spermatic vein at amean concentration that is 50 times greater than that inthe peripheral plasma These findings led to the hypothesis that local estrogen levels might be associated with the current stateof spermatogenesis or the total number of spermatogenic cells in the testis
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