ClinicalTrials.gg
Status unknownNCT03857828Updated Dec 21, 2020

Seminal Level of Clusterin Before Testicular Sperm Extraction

An observational study in Azoospermia, Nonobstructive, sponsored by Assiut University. Status unknown. Open to male participants aged 20 Years to 50 Years. Per ClinicalTrials.gov, last updated 2020-12-21.

Sponsored by Assiut University · Observational

The sponsor has not verified this record recently (last verified Dec 2020), so the status shown — last known as Not yet recruiting — may be out of date.
Study type
Observational
Model
Other
Time perspective
Prospective
Enrollment
88
Ages
20 Years to 50 Years
Sex
Male
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Study summary

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

Read the 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.

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Conditions studied

  • Azoospermia, Nonobstructive
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In context

Azoospermia, Nonobstructive

23 studies on the registry are indexed under Azoospermia, Nonobstructive; 7 are open to participants now.

This study's planned enrollment of 88 is close to the median of 94 across 10 observational studies indexed under Azoospermia, Nonobstructive.

Browse Azoospermia, Nonobstructive 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.

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

04

Who can participate

Ages eligible
20 Years to 50 Years
Sexes eligible
Male
Sampling method
Non-probability sample

Study population

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

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

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

Exclusion criteria

Exclusion Criteria:

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

Observational model
Other
Time perspective
Prospective
Enrollment
88 participants (estimated)
Patient registry
No

Interventions

  • Othersemen sample

    • seminal sample for measuring clusterin level.

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What researchers measure

Primary outcomes

  1. 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.

    Time frame: 1 hour

07

Study locations

No study locations are listed for this record.

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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Dec 21, 2020, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT03857828
Lead sponsor
Assiut University
Responsible party
Azza Sheshaey Hassan Abdelfadel Ahmad (Principal investigator, Assiut University) — Principal investigator
First posted
Feb 28, 2019
Start date
Dec 16, 2020 (estimated)
Primary completion
Dec 16, 2020 (estimated)
Completion
May 1, 2021 (estimated)
Last update
Dec 21, 2020

Study contacts

Azza Sheshaey, M.B.B.CH
Contact
azzaandel@yahoo.com
01096906812 ext. 0020
Emad Eldien Kamal, Ph.D
Contact
01004026100 ext. 0020

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 Dec 2020. You cannot join it, but the record below documents what was studied.

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