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Testicular Function After Testicular Torsion

H

Herlev and Gentofte Hospital

Status

Enrolling

Conditions

Testicular Torsion
Spermatic Cord Torsion

Study type

Observational

Funder types

Other

Identifiers

NCT04137965
Torsion study

Details and patient eligibility

About

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

Full 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

Enrollment

140 estimated patients

Sex

Male

Ages

18+ years old

Volunteers

No Healthy Volunteers

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

Trial design

140 participants in 2 patient groups

Testicular torsion group
Description:
Men having undergone surgery for testicular torsion between 01.01.2003 and 12.31.2012
Control group
Description:
Men without knowledge of their fertility status and who have never had their semen analyzed

Trial contacts and locations

1

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Central trial contact

Trine Møller Rudlang, MD; Frederik M Jacobsen

Data sourced from clinicaltrials.gov

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