NCT06307639

Brief Summary

  • Measurement of PGK2 and ACRV1 levels in the semen of infertile males undergoing testicular sperm extraction (TESE).
  • Correlate seminal levels of PGK2 and ACRV1 with sperm retrieval results and histopathology analysis of testicular biopsy samples.

Trial Health

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
64

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Apr 2024

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 6, 2024

Completed
7 days until next milestone

First Posted

Study publicly available on registry

March 13, 2024

Completed
19 days until next milestone

Study Start

First participant enrolled

April 1, 2024

Completed
1.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2025

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2026

Completed
Last Updated

March 13, 2024

Status Verified

March 1, 2024

Enrollment Period

1.5 years

First QC Date

March 6, 2024

Last Update Submit

March 6, 2024

Conditions

Male Infertility Due to Azoospermia

Outcome Measures

Primary Outcomes (2)

  • Know more about the functional role of PGK2 and ACRV1 in the process of spermatogenesis.

    2 years

  • Detect if PGK2 and/or AVRV1 level can used as predictor for spermatogenesis in infertile men with non-obstructive azoospermia undergoing Testicular Sperm Extraction.

    2 years

Interventions

Measurement of PGK2 and ACRV1 levels in the semen of infertile males undergoing testicular sperm extraction (TESE).DIAGNOSTIC_TEST

Measurement of PGK2 and ACRV1 levels in the semen of infertile males undergoing testicular sperm extraction (TESE).

Eligibility Criteria

Age18 Years - 45 Years
Sexmale
Healthy VolunteersYes
Age GroupsAdult (18-64)
Sampling MethodNon-Probability Sample
Study Population

Infertile males with normal volume, functional (non-obstructive) azoospermia.

You may qualify if:

  • Infertile males with normal volume, functional (non-obstructive) azoospermia.
  • Age: 18-45 years

You may not qualify if:

  • Patients with proven obstructive azoospermia.
  • Cryptorchidism.
  • Testicular Agenesis and testicular atrophy.
  • Patient with exposure to gonadal toxins like chemotherapy, radiotherapy, and alkylating agents.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
PROSPECTIVE
Target Duration
3 Months
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant lecturer of Andrology ,Sexology and STIs

Study Record Dates

First Submitted

March 6, 2024

First Posted

March 13, 2024

Study Start

April 1, 2024

Primary Completion

October 1, 2025

Study Completion

April 1, 2026

Last Updated

March 13, 2024

Record last verified: 2024-03

Data Sharing

IPD Sharing
Will not share