Azoospermia, NonobstructiveNCT03857828
Seminal Level of Clusterin Before Testicular Sperm Extraction
An observational study of Azoospermia, Nonobstructive, run by Assiut University.
Trial summary
Measurement of clusterin level in the semen of infertile males undergoing testicular sperm extraction. Read more about this study
- Who is it for?
- Ages 20 to 50 years, men only
- Conditions the study is for
- Azoospermia, Nonobstructive
- What is being tested?
- semen sample
- How many people
- 88 participants
- Where
- No sites listed yet
- Study dates
- 16 Dec 2020to 1 May 2021
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 50 years
- Men only
- Adult
Study population: Infertile Male patients (20 - 50 years ) with azoospermia undergoing testicular sperm extraction
Who may be able to join
- Infertile males , Azoospermia undergoing TESE as a preliminary step for ICSI .
- Age: 20-50 year
Who cannot join
- males <20 years and >50years
- Cryptorchidism .
- Testicular Agenesis and testicular atrophy .
Trial locations and contacts
No sites are listed yet.
Emad Eldien Kamal, Ph.D contact
About this study
Official title: 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.
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.
- Conditions
- Azoospermia, Nonobstructive
- Being tested
- semen sample
- Medical subject headings
- Azoospermia, Nonobstructive
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
semen sampleOther
- seminal sample for measuring clusterin level.
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 1 hour
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Feb 2019
- Study start16 Dec 2020 (estimated)
- Primary completion16 Dec 2020 (estimated)
- Study completion1 May 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Azoospermia, NonobstructiveStudies of the same condition, open and under way.
- More trials run by Assiut UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Prospective
- Enrolment
- 88 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Azza Sheshaey Hassan Abdelfadel Ahmad, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03857828
- Sponsor's protocol ID
- CLu before TESE
- Status last verified
- Dec 2020
- First submitted
- 26 Feb 2019
- Last updated
- 21 Dec 2020
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Dec 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Seminal Level of Clusterin in Infertile Men as a Predictor for Spermatogenesis Before Testicular Sperm Extraction
- ClinicalTrials.gov ID
- NCT03857828
- Acronym / sponsor ID
- CLu before TESE
- Conditions
- Azoospermia, Nonobstructive
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 88 participants (estimated)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- 16 Dec 2020 (estimated)
- Primary completion
- 16 Dec 2020 (estimated)
- Study completion
- 1 May 2021 (estimated)
- First posted
- 28 Feb 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Other
- Time perspective
- Prospective
Who may qualify
- Ages
- 20 to 50 years
- Sex
- Male only
- Age groups
- Adult
- Study population
- Infertile Male patients (20 - 50 years ) with azoospermia undergoing testicular sperm extraction
Key inclusion criteria (2 listed)
- Infertile males , Azoospermia undergoing TESE as a preliminary step for ICSI .
- Age: 20-50 year
Key exclusion criteria (3 listed)
- males <20 years and >50years
- Cryptorchidism .
- Testicular Agenesis and testicular atrophy .
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| semen sample• seminal sample for measuring clusterin level. | Other | – |
Primary outcome
The level of seminal clusterin before testicular sperm Extraction.
Time frame: 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.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Dec 2020.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Emad Eldien Kamal, Ph.D contact
Questions about this trial
What is this clinical trial studying?
An observational study of Azoospermia, Nonobstructive, run by Assiut University.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 21 Dec 2020. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Azza Sheshaey, M.B.B.CH (01096906812 ext. 0020, azzaandel@yahoo.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The level of seminal clusterin before testicular sperm Extraction. (time frame: 1 hour). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Dec 2020.