Testicular Function After Testicular Torsion

NCT ID: NCT04137965

Last Updated: 2023-02-24

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

140 participants

Study Classification

OBSERVATIONAL

Study Start Date

2022-11-01

Study Completion Date

2023-12-01

Brief Summary

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

Detailed Description

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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

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Testicular Torsion Spermatic Cord Torsion

Study Design

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Observational Model Type

CASE_CONTROL

Study Time Perspective

CROSS_SECTIONAL

Study Groups

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Testicular torsion group

Men having undergone surgery for testicular torsion between 01.01.2003 and 12.31.2012

No interventions assigned to this group

Control group

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

No interventions assigned to this group

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

No

Sponsors

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Herlev and Gentofte Hospital

OTHER

Sponsor Role lead

Responsible Party

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Frederik Møller Jacobsen

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Jens Sønksen, Professor

Role: STUDY_DIRECTOR

Herlev and Gentofte Hospital

Locations

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Department of Growth and Reproduction

Copenhagen, , Denmark

Site Status RECRUITING

Countries

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Denmark

Central Contacts

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Frederik M Jacobsen

Role: CONTACT

Trine Møller Rudlang, MD

Role: CONTACT

Facility Contacts

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Frederik Jacobsen

Role: primary

Niels Jørgensen

Role: backup

Other Identifiers

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Torsion study

Identifier Type: -

Identifier Source: org_study_id

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