Testicular Function After Testicular Torsion

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

Study Overview

• Status: Recruiting
• Conditions: Testicular Torsion; Spermatic Cord Torsion

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: Observational
• Enrollment (Anticipated): 140

Contacts and Locations

• Study Contact: Name: Frederik M Jacobsen; Phone Number: 38688949; Email: frederik.moeller.jacobsen.01@regionh.dk
• Study Contact Backup: Name: Trine Møller Rudlang, MD; Email: Trine.møller.rudlang@regionh.dk

Study Locations

• Denmark
  • Copenhagen, Denmark, 2100
    • Recruiting
    • Department of Growth and Reproduction
    • Contact: Frederik Jacobsen; Phone Number: 20356670; Email: frederik.m.j@icloud.com
    • Contact: Niels Jørgensen

Participation Criteria

Eligibility Criteria

• 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

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort
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

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Semen parameters as an indicator of overall testicular exocrine function	Compared with results from control group	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	8-17 years after surgical intervention
MAR test result correlated to the type of surgery	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	Morphology and motility (%)	8-17 years after surgical intervention
Paternity as a measure of fertility	Number of kids if any.	8-17 years after surgical intervention

Collaborators and Investigators

• Sponsor: Herlev and Gentofte Hospital
• Investigators: Study Director: Jens Sønksen, Professor, Herlev and Gentofte Hospital

Study record dates

Study Major Dates

• Study Start (Actual): November 1, 2022
• Primary Completion (Anticipated): September 1, 2023
• Study Completion (Anticipated): December 1, 2023

Study Registration Dates

• First Submitted: October 18, 2019
• First Submitted That Met QC Criteria: October 22, 2019
• First Posted (Actual): October 24, 2019

Study Record Updates

• Last Update Posted (Actual): February 24, 2023
• Last Update Submitted That Met QC Criteria: February 23, 2023
• Last Verified: February 1, 2023

More Information

Terms related to this study

• Keywords: Fertility; Testicular Torsion; Testicular function
• Additional Relevant MeSH Terms: Spermatic Cord Torsion
• Other Study ID 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