Testicular Function After Testicular Torsion

February 23, 2023 updated by: Frederik Møller Jacobsen, Herlev and Gentofte Hospital
The purpose of this study is to evaluate testicular function measured as testosterone level and semen quality.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Detailed Description

Men having undergone surgery for testicular torsion between 01.01.2003 - 12.31.2012 will receive a invitation to participate in this study. It is expected that 110 patients can be identified and about 65% of them will participate. These men will undergo a andrological evaluation, deliver a semen sample, have a blood sample taken and undergo a testicular ultrasound.

Control group:

Men attending the fertility counseling at Herlev hospital will be offered participation in this study. The fertility counseling demands that men who contact the clinic have never had their sperm analyzed, have not tried to get pregnant with their partner for more than a year and that they have no prior knowledge of their fertility.

Primary endpoint:

  • Semen quality measured as sperm concentration
  • Total testosterone level

Secondary endpoint:

Semen parameters

  • Semen volume (ml)
  • Sperm concentration (x 106/ml)
  • Sperm motility (%) (både klasse AB og ABC)
  • sperm morphology
  • IgA-bound spermatozoa (%)
  • IgG-bound spermatozoa (%)

Hormones

  • FSH
  • LH
  • PRL
  • Testosterone
  • Estradiol
  • Inhibin B
  • Insulin-like peptide 3
  • SHBG

Data points:

  • Paternity
  • Time to pregnancy
  • Partner (yes/no)
  • Any fertility treatment?
  • Pain? (VAS score)
  • Symptoms of testesterone deficiency symptoms
  • Andrological evaluation
  • Testicular ultrasound
  • Testicular torsion events in the family
  • Date of surgery
  • Date of follow up meeting
  • Surgery details

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Anticipated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
140

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Contact Backup

Study Locations

  • Denmark
      • Copenhagen, Denmark, 2100
        • Recruiting
        • Department of Growth and Reproduction
        • Contact:
        • Contact:
          • Niels Jørgensen

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Male

Sampling Method

Probability 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.

Description

Inclusion Criteria:

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

Exclusion Criteria:

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
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

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Sperm concentration
Time Frame: 8-17 years after surgical intervention
Amount of motile sperm cells (* 10^6)
8-17 years after surgical intervention
Testosterone level
Time Frame: 8-17 years after surgical intervention
ng/ml
8-17 years after surgical intervention

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Semen parameters as an indicator of overall testicular exocrine function
Time Frame: 8-17 years after surgical intervention
Compared with results from control group
8-17 years after surgical intervention
Hormone level as an indicator of testicular endocrine function
Time Frame: 8-17 years after surgical intervention
Follicle stimulating hormone, luteinizing hormone, prolactin, testosterone, estradiol, inhibin B, sex hormone-binding globulin, albumin
8-17 years after surgical intervention
MAR test result correlated to the type of surgery
Time Frame: 8-17 years after surgical intervention
MAR test of sperm cells
8-17 years after surgical intervention
Difference in sperm morphology and motility correlated to the type of surgery and compared to control group
Time Frame: 8-17 years after surgical intervention
Morphology and motility (%)
8-17 years after surgical intervention
Paternity as a measure of fertility
Time Frame: 8-17 years after surgical intervention
Number of kids if any.
8-17 years after surgical intervention

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Herlev and Gentofte Hospital

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Study Director: Jens Sønksen, Professor, Herlev and Gentofte Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
November 1, 2022

Primary Completion (Anticipated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
September 1, 2023

Study Completion (Anticipated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 1, 2023

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
October 18, 2019

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
October 22, 2019

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
October 24, 2019

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
February 24, 2023

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 23, 2023

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
February 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • Torsion study

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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