Testicular TorsionNCT04137965
Testicular Function After Testicular Torsion
An observational study of Testicular Torsion and Spermatic Cord Torsion, run by Herlev and Gentofte Hospital at 1 site in Denmark.
Trial summary
The purpose of this study is to evaluate testicular function measured as testosterone level and semen quality. Read more about this study
- Who is it for?
- Ages 18 years and older, men only
- Conditions the study is for
- Testicular Torsion, Spermatic Cord Torsion
- How many people
- 140 participants
- Where
- 1 siteDenmark
- Study dates
- 1 Nov 2022to 1 Dec 2023
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Men only
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- Men with a verified testicular torsion operated at Herlev and Gentofte hospital between 01.01.2003 and 12.31.2012
Who cannot join
- Retentio testis
- Varicocele
- Previous treatment with chemo- or radiation therapy
- Genetic disposition for infertility
- Anejculation
- Retrograde ejaculation
Trial locations and contacts
1 site in 1 country.
Trine Møller Rudlang, MD contact
Denmark1 site, 1 recruiting
- Recruiting
Department of Growth and Reproduction
Copenhagen, 2100
Frederik Jacobsen, 20356670, frederik.m.j@icloud.com
Niels Jørgensen
About this study
The purpose of this study is to evaluate testicular function measured as testosterone level and semen quality.
Read the 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
- Conditions
- Testicular Torsion, Spermatic Cord Torsion
- Keywords
- Fertility, Testicular Torsion, Testicular function
- Medical subject headings
- Spermatic Cord Torsion
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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 being measured
The primary outcome is the main question the study is designed to answer.
Sperm concentration
Amount of motile sperm cells (* 10^6)
Measured: 8-17 years after surgical intervention
Testosterone level
ng/ml
Measured: 8-17 years after surgical intervention
Secondary outcomes (5)
Semen parameters as an indicator of overall testicular exocrine function
Compared with results from control group
Measured: 8-17 years after surgical intervention
Hormone level as an indicator of testicular endocrine function
Follicle stimulating hormone, luteinizing hormone, prolactin, testosterone, estradiol, inhibin B, sex hormone-binding globulin, albumin
Measured: 8-17 years after surgical intervention
MAR test result correlated to the type of surgery
MAR test of sperm cells
Measured: 8-17 years after surgical intervention
Difference in sperm morphology and motility correlated to the type of surgery and compared to control group
Morphology and motility (%)
Measured: 8-17 years after surgical intervention
Paternity as a measure of fertility
Number of kids if any.
Measured: 8-17 years after surgical intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Oct 2019
- Study start1 Nov 2022
- Primary completion1 Sep 2023 (estimated)
- Study completion1 Dec 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Testicular TorsionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Enrolment
- 140 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Herlev and Gentofte Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Frederik Møller Jacobsen, Herlev and Gentofte Hospital
- Investigators
- Jens Sønksen, Professor, Study director, Herlev and Gentofte Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04137965
- Sponsor's protocol ID
- Torsion study
- Status last verified
- Feb 2023
- First submitted
- 18 Oct 2019
- Last updated
- 24 Feb 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Feb 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Testicular Function After Testicular Torsion
- ClinicalTrials.gov ID
- NCT04137965
- Acronym / sponsor ID
- Torsion study
- Conditions
- Testicular Torsion, Spermatic Cord Torsion
- Keywords
- Fertility, Testicular Torsion, Testicular function
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 140 participants (estimated)
- Lead sponsor
- Herlev and Gentofte HospitalUniversity, hospital or other
- Study start
- 1 Nov 2022 (actual)
- Primary completion
- 1 Sep 2023 (estimated)
- Study completion
- 1 Dec 2023 (estimated)
- First posted
- 24 Oct 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to evaluate testicular function measured as testosterone level and semen quality.
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 design
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 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 |
Who may qualify
- Ages
- 18 years and older
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (1 listed)
- Men with a verified testicular torsion operated at Herlev and Gentofte hospital between 01.01.2003 and 12.31.2012
Key exclusion criteria (6 listed)
- Retentio testis
- Varicocele
- Previous treatment with chemo- or radiation therapy
- Genetic disposition for infertility
- Anejculation
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Sperm concentration
Time frame: 8-17 years after surgical intervention
Amount of motile sperm cells (* 10^6)
Testosterone level
Time frame: 8-17 years after surgical intervention
ng/ml
5 secondary outcomes
Semen parameters as an indicator of overall testicular exocrine function
Time frame: 8-17 years after surgical intervention
Hormone level as an indicator of testicular endocrine function
Time frame: 8-17 years after surgical intervention
MAR test result correlated to the type of surgery
Time frame: 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
Paternity as a measure of fertility
Time frame: 8-17 years after surgical intervention
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Feb 2023.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Trine Møller Rudlang, MD contact
Jens Sønksen, Professor study director
Herlev and Gentofte Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Testicular Torsion and Spermatic Cord Torsion, run by Herlev and Gentofte Hospital at 1 site in Denmark.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 24 Feb 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Denmark. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Frederik M Jacobsen (38688949, frederik.moeller.jacobsen.01@regionh.dk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Sperm concentration (time frame: 8-17 years after surgical intervention). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Feb 2023; AzTrials last refreshed its copy on 27 Oct 2026.