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Seminal Level of Clusterin & Serum Testosterone/Estradiol Ratio Before Testicular Sperm Extraction

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. Identifier: NCT03857828
Recruitment Status : Not yet recruiting
First Posted : February 28, 2019
Last Update Posted : February 28, 2019
Information provided by (Responsible Party):
Azza Sheshaey Hassan Abdelfadel Ahmad, Assiut University

Brief Summary:

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

Measurement of testosterone/estradiol ratio in the serum of infertile males undergoing testicular sperm extraction.

Condition or disease Intervention/treatment
Azoospermia, Nonobstructive Other: Blood sample and 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.

Testosterone has long been known to be the dominant sex hormone in men. However, estrogen is found at detectable levels at multiple points of development and contributes to spermatogenesis.

In addition, an abnormal T/E ratio (<10) has been associated with decreased semen parameters.

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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Study Type : Observational
Estimated Enrollment : 50 participants
Observational Model: Other
Time Perspective: Prospective
Official Title: Seminal Level of Clusterin & Serum Testosterone/Estradiol Ratio in Infertile Men as a Predictor for Spermatogenesis Before Testicular Sperm Extraction
Estimated Study Start Date : April 1, 2019
Estimated Primary Completion Date : April 1, 2020
Estimated Study Completion Date : May 1, 2020

Resource links provided by the National Library of Medicine

Intervention Details:
  • Other: Blood sample and semen sample
    • Blood sample for measuring level of testosterone and estradiol E2.
    • serum sample for measuring clusterin level.

Primary Outcome Measures :
  1. The level of seminal clusterin & serum testosterone/estradiol E2 ratio before testicular sperm Extraction. [ Time Frame: 1 hour ]
    Measurement of seminal clusterin and serum testosterone/estradiol ratio 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.

Information from the National Library of Medicine

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Ages Eligible for Study:   20 Years to 50 Years   (Adult)
Sexes Eligible for Study:   Male
Gender Based Eligibility:   Yes
Sampling Method:   Non-Probability Sample
Study Population
Infertile Male patients (20 - 50 years ) with azoospermia undergoing testicular sperm extraction

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 .

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT03857828

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Contact: Azza Sheshaey, M.B.B.CH 01096906812 ext 0020
Contact: Emad Eldien Kamal, Ph.D 01004026100 ext 0020

Sponsors and Collaborators
Assiut University

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Responsible Party: Azza Sheshaey Hassan Abdelfadel Ahmad, Principal investigator, Assiut University Identifier: NCT03857828     History of Changes
Other Study ID Numbers: CLu & T/E2 before TESE
First Posted: February 28, 2019    Key Record Dates
Last Update Posted: February 28, 2019
Last Verified: February 2019

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Estradiol 3-benzoate
Estradiol 17 beta-cypionate
Polyestradiol phosphate
Infertility, Male
Genital Diseases, Male
Testosterone undecanoate
Testosterone enanthate
Testosterone 17 beta-cypionate
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Antineoplastic Agents, Hormonal
Antineoplastic Agents
Anabolic Agents
Contraceptive Agents
Reproductive Control Agents
Contraceptive Agents, Female