NCT06154954: Genomics

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

Status unknown Last updated 4 December 2023

What this trial tests

trial testing Semen analysis in Non-obstructive Azoospermia in 90 participants. Status unknown.

Timeline

1 June 2022

Primary endpoint
30 December 2023

30 March 2024

Quick facts

Lead sponsor	Cairo University
Status	Status unknown
Study type	OBSERVATIONAL
Enrollment	90
Start date	1 June 2022
Primary completion	30 December 2023
Estimated completion	30 March 2024
Sites	1 location across Egypt

Drugs / interventions tested

• Semen analysis

Conditions studied

• Non-obstructive Azoospermia — all drugs for Non-obstructive Azoospermia →

Sponsor

Cairo University

Who can join

18 and older, male only, with Non-obstructive Azoospermia. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

No peer-reviewed publications indexed yet for this trial.