ClinicalTrials.gg
Sign In
Status unknownNCT04308486Updated Mar 16, 2020

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

An observational study in Non-obstructive Azoospermia, sponsored by Assiut University. Status unknown. Open to male participants aged 20 Years to 50 Years. Per ClinicalTrials.gov, last updated 2020-03-16.

Sponsored by Assiut University · Observational

The sponsor has not verified this record recently (last verified Mar 2020), so the status shown — last known as Not yet recruiting — may be out of date.
Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
50
Ages
20 Years to 50 Years
Sex
Male
01

Study summary

*Evaluate the predictive value of AMH, Testosterone,Estradiol,Testosterone Estradiol ratio for TESA and TESE outcome in non obstructive azoospermic patients.

Read the 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.
02

Conditions studied

  • Non-obstructive Azoospermia

Browse trials for

03

In context

Azoospermia

59 studies on the registry are indexed under Azoospermia; 17 are open to participants now.

This study's planned enrollment of 50 is below the median of 95 across 24 observational studies indexed under Azoospermia.

Browse Azoospermia studies →

Lead sponsor

Assiut University is the lead sponsor of 5,078 studies on the registry; 2,178 are open to participants now.

Of its 14 completed or terminated interventional studies of FDA-regulated products, 0 (0%) have results posted.

Browse Assiut University studies →

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
20 Years to 50 Years
Sexes eligible
Male
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

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

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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

Exclusion Criteria:

  • obstructive azoospermia
  • congenital bilateral absent vas
05

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
50 participants (estimated)
Patient registry
No
06

What researchers measure

Primary outcomes

  1. 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

07

Study locations

No study locations are listed for this record.

08

References and documents

Publications

  • Alfano M, Ventimiglia E, Locatelli I, Capogrosso P, Cazzaniga W, Pederzoli F, Frego N, Matloob R, Sacca A, Pagliardini L, Vigano P, Zerbi P, Nebuloni M, Pontillo M, Montorsi F, Salonia A. Anti-Mullerian Hormone-to-Testosterone Ratio is Predictive of Positive Sperm Retrieval in Men with Idiopathic Non-Obstructive Azoospermia. Sci Rep. 2017 Dec 15;7(1):17638. doi: 10.1038/s41598-017-17420-z. PubMed 29247212 ↗
  • Matuszczak E, Hermanowicz A, Komarowska M, Debek W. Serum AMH in Physiology and Pathology of Male Gonads. Int J Endocrinol. 2013;2013:128907. doi: 10.1155/2013/128907. Epub 2013 Oct 24. PubMed 24282408 ↗
  • Toulis KA, Iliadou PK, Venetis CA, Tsametis C, Tarlatzis BC, Papadimas I, Goulis DG. Inhibin B and anti-Mullerian hormone as markers of persistent spermatogenesis in men with non-obstructive azoospermia: a meta-analysis of diagnostic accuracy studies. Hum Reprod Update. 2010 Nov-Dec;16(6):713-24. doi: 10.1093/humupd/dmq024. Epub 2010 Jul 1. PubMed 20601364 ↗
09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Mar 16, 2020, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT04308486
Lead sponsor
Assiut University
Responsible party
Reham Ahmed Ashraf Fakhr Eldeen Hamoda (Doctor, Assiut University) — Principal investigator
First posted
Mar 16, 2020
Start date
Dec 2020 (estimated)
Primary completion
Dec 2021 (estimated)
Completion
Feb 2022 (estimated)
Last update
Mar 16, 2020

Study contacts

Reham Ahmed Ashraf, master student
Contact
salmasassojoe@gmail.com
01093001232
Emad Eldien Kamal Ali, Professror Doctor
Contact
emad@fertility-eg.com
01004026100

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Mar 2020. You cannot join it, but the record below documents what was studied.

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Other studies in this condition

Azoospermia →

Other studies from this sponsor

Assiut University →

Start the discussion