Anti-mullerian Hormone,Testesterone,Esrtadiol,Testesterone/Esrtadiol Ratio as Predictive Values for TESA and TESE Outcome in Non Obstructive Azoospermia

March 13, 2020 updated by: Reham Ahmed Ashraf Fakhr Eldeen Hamoda, Assiut University
*Evaluate the predictive value of AMH, Testosterone,Estradiol,Testosterone Estradiol ratio for TESA and TESE outcome in non obstructive azoospermic patients.

Study Overview

Status

Unknown

Conditions

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 phenotype),and 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 Type

Observational

Enrollment (Anticipated)

50

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

20 years to 50 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Male

Sampling Method

Non-Probability Sample

Study Population

50 men within 20 to 50 years with non obstructive azoospermia undergoing TESA or TESE

Description

Inclusion Criteria:

  • a clinical diagnosis of NOA associated with primary couple's infertility;
  • age from 20 to 50 years old
  • freedom from any known systemic diseases affecting the previous hormonal levels such as liver cirrhosis .
  • hormonal therapy for at least two weeks prior to the surgery

Exclusion Criteria:

  • obstructive azoospermia
  • congenital bilateral absent vas

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Evaluate the predictive value of Anti-mullerian hormone,Testosterone,Estradiol,Testosterone/Estradiol ratio for TESA and TESE outcome in non obstructive azoospermia
Time Frame: baseline
baseline

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Assiut University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Anticipated)

December 1, 2020

Primary Completion (Anticipated)

December 1, 2021

Study Completion (Anticipated)

February 1, 2022

Study Registration Dates

First Submitted

March 10, 2020

First Submitted That Met QC Criteria

March 13, 2020

First Posted (Actual)

March 16, 2020

Study Record Updates

Last Update Posted (Actual)

March 16, 2020

Last Update Submitted That Met QC Criteria

March 13, 2020

Last Verified

March 1, 2020

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • prediction of TESA and TESE

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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