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Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT03857828
Other study ID # CLu before TESE
Secondary ID
Status Not yet recruiting
Phase
First received
Last updated
Start date December 16, 2020
Est. completion date May 1, 2021

Study information

Verified date December 2020
Source Assiut University
Contact Azza Sheshaey, M.B.B.CH
Phone 01096906812
Email azzaandel@yahoo.com
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

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


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.


Recruitment information / eligibility

Status Not yet recruiting
Enrollment 88
Est. completion date May 1, 2021
Est. primary completion date December 16, 2020
Accepts healthy volunteers
Gender Male
Age group 20 Years to 50 Years
Eligibility 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


Related Conditions & MeSH terms


Intervention

Other:
semen sample
• seminal sample for measuring clusterin level.

Locations

Country Name City State
n/a

Sponsors (1)

Lead Sponsor Collaborator
Assiut University

Outcome

Type Measure Description Time frame Safety issue
Primary 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
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