NCT04308486

Brief Summary

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

Trial Health

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
50

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Dec 2020

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 10, 2020

Completed
6 days until next milestone

First Posted

Study publicly available on registry

March 16, 2020

Completed
9 months until next milestone

Study Start

First participant enrolled

December 1, 2020

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2021

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2022

Completed
Last Updated

March 16, 2020

Status Verified

March 1, 2020

Enrollment Period

1 year

First QC Date

March 10, 2020

Last Update Submit

March 13, 2020

Conditions

Non-obstructive Azoospermia

Outcome Measures

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

    baseline

Eligibility Criteria

Age20 Years - 50 Years
Sexmale
Healthy VolunteersNo
Age GroupsAdult (18-64)
Sampling MethodNon-Probability Sample
Study Population

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

You may qualify if:

  • 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

You may not qualify if:

  • obstructive azoospermia
  • congenital bilateral absent vas

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (3)

  • 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.

    PMID: 29247212BACKGROUND

  • 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.

    PMID: 24282408BACKGROUND

  • 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.

    PMID: 20601364BACKGROUND

Central Study Contacts

Reham Ahmed Ashraf, master student

CONTACT

01093001232salmasassojoe@gmail.com

Emad Eldien Kamal Ali, Professror Doctor

CONTACT

01004026100emad@fertility-eg.com

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Doctor

Study Record Dates

First Submitted

March 10, 2020

First Posted

March 16, 2020

Study Start

December 1, 2020

Primary Completion

December 1, 2021

Study Completion

February 1, 2022

Last Updated

March 16, 2020

Record last verified: 2020-03