Testicular Proteins for Sperm Retrieval Prediction Protein1, Testis-Expressed Gene 101, and Lectin Galactoside-binding Protein in Predicting Surgical Sperm Retrieval in Men With Non-Obstructive Azoospermia

NCT06154954 | Unknown

• 1 other identifier: MD-2024
• Study Type: observational
• Target: 90
• Locations: 1 country
• Sites: 1

Brief Summary

Generally, azoospermia is characterized as obstructive (OA) or nonobstructive (NOA). Surgical spermatozoa retrieval results vary in success rates. Proposing Intracytoplasmic Sperm Injection (ICSI) to infertile couples with NOA depends on spermatogenesis, testicular histology, and the ability to extract live spermatozoa from testis biopsy pieces. Unfortunately, only 50% of testicular sperm extraction (TESE) results are positive (Zarezadeh et al., 2021). Repeating sperm retrieval can cause TESE-induced hypoganadism, including reduced testicular volume, erectile dysfunction, and testosterone deficiency (Eliveld et al., 2018; Okada et al., 2002; Ozturk et al., 2011; Altinkilic et al., 2017; Akbal et al., 2017; Binsaleh et al., 2017). The prognostic efficacy of hormonal, molecular, cytological, and biochemical indicators for effective sperm recovery is limited (Corona et al., 2019). Molecular, biochemical, clinical, and histopathological characteristics that identify NOA males with advanced spermatogenesis foci up to the spermatozoon stage are crucial for therapeutic purposes. Recent research suggests that seminal protein expression patterns change dramatically between azoospermic and fertile males (Zhang et al., 2021). TEX101 is a membrane protein only produced by testicular germ cells and shed into seminal plasma (SP). Research suggests that Tex101 malfunctions may impact male fertility (Jarvi et al., 2021). TEX101 is a germ cell mono-specific marker present on sperm, round spermatids, and spermatocytes. At a threshold of \>5 ng/mL, TEX101 can distinguish NOA with Sertoli-cell only syndrome from other testis histologies, such as hypospermatogenesis (67% specificity, 100% sensitivity) or maturation arrest (54% sensitivity, 100% specificity) (Drabovich et al., 2013). ECM1, an epididymal mono-specific marker, was below detection limits in males with OA semen but present in detectable levels. Research Template 3: Final Version: April 2019 NOA amounts in males. Clinical immunoassays of ECM1 and TEX101 can predict sperm retrieval outcomes for assisted reproduction and lower the cost of diagnosing azoospermia. ELISA confirms that the lectin galactoside-binding, soluble 3 binding protein (LGALS3BP) is expressed throughout the male genital tract. Its physiological role in cell-to-cell interaction through extracellular matrix suggests a possible role in spermatogenesis, particularly in the late stage, despite not being a germ-cell specific marker (Cannarella et al., 2020). Patients with a good result of TESE had significantly greater levels of LGALS3BP in the SP. A cut-off of 153 ng/mL was observed with 100% sensitivity and 45% specificity. Freour et al. (2013) identified a key issue in their analysis due to the small number of instances (n=40) with lower AUC values. Araujo and Bertolla (2021) propose that LGALS3BP may predict TESE success in NOA patients before ICSI.

Conditions

Non-obstructive Azoospermia

Outcome Measures

Primary Outcomes (1)

• Calculating the cut off level of the following markers a. ECM, b. TEX 101 and c. LAGALS3BP

  These proteins if present, they would provide the highest yield of sperms

  6 months

Interventions

Semen analysis DIAGNOSTIC_TEST

Semen analysis for extracellular matrix proteins analysis

Eligibility Criteria

• Age: 18 Years+
• Gender Eligibility Details: Males 46,XY
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Azoospermic patients whom are scheduled for TESE operation attending at Andrology clinic, Kasr Al Ainy hospital.

You may qualify if:

• Men with Non-obstructive azoospermia

You may not qualify if:

• Sex reversal syndrome.
• Macro-deletion on the Y chromosome (To those accepting the chromosomal study)
• AZF a, AZF b microdeletion (To those accepting the Y chromosome microdeletion analysis).
• Obstructive azoospermia.
• Undescended testis.
• Hypogonadotrophic Hypogonadism
• Testicular procedures and operations -

Sponsors & Collaborators

• Cairo University: lead

Study Sites (1)

Cairo University hospital, department of andrology

Cairo, 11451, Egypt

RECRUITING

MeSH Terms

Interventions

Semen Analysis

Intervention Hierarchy (Ancestors)

Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Investigative Techniques

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Lecturer

Study Record Dates

• First Submitted: November 24, 2023
• First Posted: December 4, 2023
• Study Start: June 1, 2022
• Primary Completion: December 30, 2023
• Study Completion: March 30, 2024
• Last Updated: December 4, 2023

Record last verified: 2023-11

Data Sharing

• IPD Sharing: Will not share

Locations

EG (1)