Testicular Function After Testicular Torsion

Recruiting

• Conditions: Testicular Torsion; Spermatic Cord Torsion

• Registration Number: NCT04137965
• Lead Sponsor: Herlev and Gentofte Hospital

Brief Summary

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 Timeline

• Study First Submitted: 2019-10-18
• Study First Submitted QC: 2019-10-22
• Study First Posted: 2019-10-24
• Study Start: 2022-11-01
• Status Verified: 2023-02
• Last Update Submitted: 2023-02-23
• Last Update Posted: 2023-02-24
• Primary Completion: 2023-09-01
• Study Completion: 2023-12-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: Male
• Target Recruitment: 140

Inclusion Criteria

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

Read More

Exclusion Criteria

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

Read More

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Testosterone level	8-17 years after surgical intervention	ng/ml
Sperm concentration	8-17 years after surgical intervention	Amount of motile sperm cells (\* 10\^6)

Secondary Outcome Measures

Name	Time	Method
Semen parameters as an indicator of overall testicular exocrine function	8-17 years after surgical intervention	Compared with results from control group
Hormone level as an indicator of testicular endocrine function	8-17 years after surgical intervention	Follicle stimulating hormone, luteinizing hormone, prolactin, testosterone, estradiol, inhibin B, sex hormone-binding globulin, albumin
MAR test result correlated to the type of surgery	8-17 years after surgical intervention	MAR test of sperm cells
Difference in sperm morphology and motility correlated to the type of surgery and compared to control group	8-17 years after surgical intervention	Morphology and motility (%)
Paternity as a measure of fertility	8-17 years after surgical intervention	Number of kids if any.

Trial Locations

Locations (1)

Department of Growth and Reproduction; 🇩🇰 Copenhagen, Denmark