Could miRNAs be Used as Markers for Distinguishing Undescended Testicles From Retractile Testicles

NCT07315737 | Completed

• 2 other identifiers: 2022/25A-2109
• Study Type: observational
• Target: 28
• Locations: 1 country
• Sites: 1

Brief Summary

Background: Undescended testicles (UDTs) are common in male infants. Untreated UDT poses risks such as infertility (IF), testicular cancer (TC), and testicular torsion (TT). Retractile testicles (RTs) sporadically ascend from the scrotum. UDT requires early surgical correction, whereas RT requires only periodic follow-up. Differentiating these conditions is challenging, making clinical biomarkers potentially useful. The aim of our study was to examine the use of miRNAs, which are difficult to differentiate, as biomarkers in the differential diagnosis of UDT and RT. Methods: This prospective study included 10 boys with UDT (operated), 9 with RT (followed), and 9 controls. Parent consent and serum samples were collected to evaluate miR-210, miR-34c, and miR-449a expression via real-time PCR. For group comparisons, one-way ANOVA was used for parametric data, and the Kruskal-Wallis test was used for nonparametric data, followed by the Dunn-Bonferroni correction for post hoc multiple comparisons. Spearman's rank correlation coefficient was used to analyse correlations. A p value \< 0.05 was considered significant.

Conditions

MIRAS; Testicular Abnominalies; Undescended Testes

Keywords

Cryptorchidism; Undescended testicle; Retractile testicle; miRNA; Infertility; Testicular cancer

Outcome Measures

Primary Outcomes (2)

• miRNA levels

  2Ct (target gene) - Ct (reference gene)

  Within study enrollement

• miRNA changes

  Differentiation of miRNA levels in three arms

  Rapid miRNA levels at study enrollement time.

Study Arms (3)

Undescended Testicle

Undescended testicle cases whose miRNA levels investigated

Diagnostic Test: miRNA

Retractile testicle

Retractile testicle cases whose miRNA levels investigated

Diagnostic Test: miRNA

Control

Healthy kids with testes in the scrotum whose miRNA levels investigated

Diagnostic Test: miRNA

Interventions

miRNA DIAGNOSTIC_TEST

miR-34c , miR-210 , miR-449a levels investigated.

Control; Retractile testicle; Undescended Testicle

Eligibility Criteria

• Age: 3 Months - 18 Years
• Gender Eligibility Details: The study depends on undescended testicle which is a pathology related to male gender
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

Control group: Healthy kids with both testes in scrotum. Undescended testis group: Kids with unilateral palpable undescended testis or bilateral palpable testes. Recractile testis group: Kids under monitorisation for unilateral retractile testis or bilateral retractile testes.

You may qualify if:

• Palpable (unilateral or bilateral) undescended testis cases
• Retractile testis cases; physician examinations were performed in three positions (supine, semisupine, standing), followed by a 1-month parental examination (twice daily).
• Healty kids less than 18 years old with palpable two testes palpable in scrotum.

You may not qualify if:

• Prior inguinal/scrotal surgery
• Defective datasets
• Unsuitable serum samples

Sponsors & Collaborators

• Dr. Mevlüt Keleş: lead

Study Sites (1)

Ordu University

Ordu, Altınordu, 52200, Turkey (Türkiye)

Location

Related Publications (24)

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Biospecimen

Retention: SAMPLES WITH DNA

Serum samples collected for miRNA analysis.

MeSH Terms

Conditions

Ataxia Neuropathy Spectrum; Cryptorchidism; Infertility; Testicular Neoplasms

Condition Hierarchy (Ancestors)

Testicular Diseases; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Male Urogenital Diseases; Urogenital Abnormalities; Congenital Abnormalities; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Gonadal Disorders; Endocrine System Diseases; Endocrine Gland Neoplasms; Neoplasms by Site; Neoplasms; Genital Neoplasms, Male; Urogenital Neoplasms

Study Officials

• Benli

  Ordu University

  STUDY CHAIR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Assistant professor

Study Record Dates

• First Submitted: November 23, 2025
• First Posted: January 2, 2026
• Study Start: March 1, 2022
• Primary Completion: March 31, 2023
• Study Completion: April 30, 2023
• Last Updated: January 2, 2026

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)