Seminal Level of Clusterin Before Testicular Sperm Extraction

• Conditions: Azoospermia, Nonobstructive

• Registration Number: NCT03857828
• Lead Sponsor: Assiut University

Brief Summary

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

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 Timeline

• Study First Submitted: 2019-02-26
• Study First Submitted QC: 2019-02-27
• Study First Posted: 2019-02-28
• Status Verified: 2020-12
• Study Start: 2020-12-16
• Primary Completion: 2020-12-16
• Last Update Submitted: 2020-12-17
• Last Update Posted: 2020-12-21
• Study Completion: 2021-05-01

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: Male
• Target Recruitment: 88

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
The level of seminal clusterin before testicular sperm Extraction.	1 hour	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.