Seminal Level of Clusterin Before Testicular Sperm Extraction

Seminal Level of Clusterin in Infertile Men as a Predictor for Spermatogenesis Before Testicular Sperm Extraction

Measurement of clusterin level in the semen of infertile males undergoing testicular sperm extraction.

Study Overview

• Status: Unknown
• Conditions: Azoospermia, Nonobstructive
• Intervention / Treatment: Other: semen sample

Detailed Description

Clusterin, known as apolipoprotein J, sulphated glycoprotein-2 or testosterone - repressed prostate message-2.

It plays important roles in several pathophysiological processes, including tissue remodelling, lipid transport, reproduction, complement regulation and apoptotic cell death .

As clusterin expression is markedly upregulated in various normal and malignant tissues undergoing apoptosis, it has been regarded as a marker for cell death.

There is a conflicting findings concerning the relationship between elevated clusterin expression and enhanced induction of apoptosis; that is, clusterin has appeared to have a powerful anti-apoptotic function through a chaperone-like activity.

In addition to the anti-apoptotic activity, seminal clusterin was reported to promote a tolerogenic response to male antigens, thereby contributing to female tolerance to seminal antigens.

In the testis, clusterin is secreted by Sertoli cells into the fluid of the seminiferous epithelium and deposited onto the membranes of elongating spermatids and mature spermatozoa.

To date, however, there has been little information with respect to the functional roles of clusterin in the male reproductive tract under physiological conditions.

In particular, it remains controversial as to whether or not clusterin helps assist the normal spermatogenesis.

Nonobstructive azoospermia (NOA) males are characterised by impaired spermatogenesis.

Although NOA patients have impaired global spermatogenic function, focal areas of spermatogenesis may still exist in their testes.

Focal spermatogenesis could possibly be obtained by testicular sperm extraction (TESE) technique .

A number of factors have been suggested to be of predictive value for patients with a good chance to retrieve sperm cell such as testicular volume, serum FSH levels , serum total testosterone and serum inhibin B levels.

• Study Type: Observational
• Enrollment (Anticipated): 88

Contacts and Locations

• Study Contact: Name: Azza Sheshaey, M.B.B.CH; Phone Number: 0020 01096906812; Email: azzaandel@yahoo.com
• Study Contact Backup: Name: Emad Eldien Kamal, Ph.D; Phone Number: 0020 01004026100

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years to 50 years (ADULT)
• Accepts Healthy Volunteers: N/A
• Genders Eligible for Study: Male

• Sampling Method: Non-Probability Sample

Study Population

Infertile Male patients (20 - 50 years ) with azoospermia undergoing testicular sperm extraction

Description

Inclusion Criteria:

• Infertile males , Azoospermia undergoing TESE as a preliminary step for ICSI .
• Age: 20-50 year

Exclusion Criteria:

• males <20 years and >50years
• Cryptorchidism .
• Testicular Agenesis and testicular atrophy .

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
The level of seminal clusterin before testicular sperm Extraction.	Measurement of seminal clusterin by enzyme-linked immunosorbent assay (ELISA) and correlate them with the outcome of testicular sperm extraction to recognize predictors for spermatogenesis before testicular sperm extraction.	1 hour

Collaborators and Investigators

• Sponsor: Assiut University

Study record dates

Study Major Dates

• Study Start (ANTICIPATED): December 16, 2020
• Primary Completion (ANTICIPATED): December 16, 2020
• Study Completion (ANTICIPATED): May 1, 2021

Study Registration Dates

• First Submitted: February 26, 2019
• First Submitted That Met QC Criteria: February 27, 2019
• First Posted (ACTUAL): February 28, 2019

Study Record Updates

• Last Update Posted (ACTUAL): December 21, 2020
• Last Update Submitted That Met QC Criteria: December 17, 2020
• Last Verified: December 1, 2020

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Infertility, Male; Infertility; Azoospermia
• Other Study ID Numbers: CLu before 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