NCT07286279

Brief Summary

The goal of this retrospective observational study is to learn whether certain clinical characteristics can help predict which infertile men may successfully have sperm retrieved using a less-invasive "mini-incision" version of micro-TESE. The study focuses on men with very low or absent sperm counts (non-obstructive azoospermia, cryptozoospermia, or severe OAT). The main questions it aims to answer are: Can sperm be successfully found using only a small, limited-dissection micro-TESE in some men? Which clinical factors (such as hormone levels or medical history) help identify men who may benefit from this less-invasive approach? Researchers will compare men who had successful sperm retrieval with the mini-incision alone to men who required a more extensive micro-TESE to see if certain characteristics predict which approach is likely to work.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
248

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Dec 2025

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

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

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

December 3, 2025

Completed
12 days until next milestone

Study Start

First participant enrolled

December 15, 2025

Completed
1 day until next milestone

First Posted

Study publicly available on registry

December 16, 2025

Completed
15 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2025

Completed
15 days until next milestone

Study Completion

Last participant's last visit for all outcomes

January 15, 2026

Completed
Last Updated

February 27, 2026

Status Verified

February 1, 2026

Enrollment Period

16 days

First QC Date

December 3, 2025

Last Update Submit

February 24, 2026

Conditions

Keywords

micro-TESEmale infertilitynon-obstructive azoospermiacryptozoospermiaoligoasthenoteratozoospermiamini-incision

Outcome Measures

Primary Outcomes (1)

  • Successful sperm retrieval rate defined as the presence of spermatozoa during limited dissection (mini-incision) micro-TESE

    At the time of limited dissection (mini-incision)

Secondary Outcomes (5)

  • Serum FSH levels

    At baseline

  • Serum testosterone levels

    At baseline

  • Testicular volume

    At baseline

  • Genetic abnormalities rate

    At baseline

  • Procedure conversion from limited to extensive micro-TESE rate

    At the time of limited dissection (mini-incision)

Eligibility Criteria

Age18 Years+
Sexmale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Men who underwent micro-TESE procedure from March 2015 to June 2025

You may qualify if:

  • Patients with cryptozoospermia or non obstructive azoospermia that underwent a micro-TESE

You may not qualify if:

  • Patients with a potentially reversible cause of cryptozoospermia (i.e., presence of a varicocele, febrile illness, or recent toxin exposure)
  • Patients with suspected partial genital tract obstruction (i.e post-vaso-vasostomy, post-vasoepididymostomy, and low volume cryptozoospermia with ejaculatory duct obstruction)
  • Patients who have previously undergone a micro-TESE, TESA or TESE procedure

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Clinique ovo

Montreal, Quebec, H4P 2S4, Canada

Location

MeSH Terms

Conditions

OligospermiaInfertility, Male

Condition Hierarchy (Ancestors)

Genital Diseases, MaleGenital DiseasesUrogenital DiseasesInfertilityMale Urogenital Diseases

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 3, 2025

First Posted

December 16, 2025

Study Start

December 15, 2025

Primary Completion

December 31, 2025

Study Completion

January 15, 2026

Last Updated

February 27, 2026

Record last verified: 2026-02

Data Sharing

IPD Sharing
Will not share

Locations