NCT04137965

Brief Summary

The purpose of this study is to evaluate testicular function measured as testosterone level and semen quality.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
140

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Nov 2022

Geographic Reach
1 country

1 active site

Status
unknown

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

October 18, 2019

Completed
6 days until next milestone

First Posted

Study publicly available on registry

October 24, 2019

Completed
3 years until next milestone

Study Start

First participant enrolled

November 1, 2022

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2023

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2023

Completed
Last Updated

February 24, 2023

Status Verified

February 1, 2023

Enrollment Period

10 months

First QC Date

October 18, 2019

Last Update Submit

February 23, 2023

Conditions

Testicular TorsionSpermatic Cord Torsion

Keywords

FertilityTesticular TorsionTesticular function

Outcome Measures

Primary Outcomes (2)

  • Sperm concentration

    Amount of motile sperm cells (\* 10\^6)

    8-17 years after surgical intervention

  • Testosterone level

    ng/ml

    8-17 years after surgical intervention

Secondary Outcomes (5)

  • Semen parameters as an indicator of overall testicular exocrine function

    8-17 years after surgical intervention

  • Hormone level as an indicator of testicular endocrine function

    8-17 years after surgical intervention

  • MAR test result correlated to the type of surgery

    8-17 years after surgical intervention

  • Difference in sperm morphology and motility correlated to the type of surgery and compared to control group

    8-17 years after surgical intervention

  • Paternity as a measure of fertility

    8-17 years after surgical intervention

Study Arms (2)

Testicular torsion group

Men having undergone surgery for testicular torsion between 01.01.2003 and 12.31.2012

Control group

Men without knowledge of their fertility status and who have never had their semen analyzed

Eligibility Criteria

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

Men with a verified testicular torsion operated at Herlev and Gentofte hospital between 01.01.2003 and 12.31.2012. This ensures atleast 5 years of follow up.

You may qualify if:

  • Men with a verified testicular torsion operated at Herlev and Gentofte hospital between 01.01.2003 and 12.31.2012

You may not qualify if:

  • Retentio testis
  • Varicocele
  • Previous treatment with chemo- or radiation therapy
  • Genetic disposition for infertility
  • Anejculation
  • Retrograde ejaculation

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Department of Growth and Reproduction

Copenhagen, 2100, Denmark

RECRUITING

MeSH Terms

Conditions

Spermatic Cord Torsion

Condition Hierarchy (Ancestors)

Genital Diseases, MaleGenital DiseasesUrogenital DiseasesMale Urogenital Diseases

Study Officials

  • Jens Sønksen, Professor

    Herlev and Gentofte Hospital

    STUDY DIRECTOR

Central Study Contacts

Frederik M Jacobsen

CONTACT

38688949frederik.moeller.jacobsen.01@regionh.dk

Trine Møller Rudlang, MD

CONTACT

Trine.møller.rudlang@regionh.dk

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

October 18, 2019

First Posted

October 24, 2019

Study Start

November 1, 2022

Primary Completion

September 1, 2023

Study Completion

December 1, 2023

Last Updated

February 24, 2023

Record last verified: 2023-02

Locations

DK(1)