Testicular Function After Testicular Torsion

Testicular Torsion Clinical Trial

Official title:

Testicular Function After Testicular Torsion

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04137965
• Other study ID #: Torsion study
• Status: Recruiting
• Start date: November 1, 2022
• Est. completion date: December 1, 2023

Study information

• Verified date: February 2023
• Source: Herlev and Gentofte Hospital
• Contact: Frederik M Jacobsen
• Phone: 38688949
• Email: frederik.moeller.jacobsen.01[@]regionh.dk
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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

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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 140
• Est. completion date: December 1, 2023
• Est. primary completion date: September 1, 2023
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Spermatic Cord Torsion
• Testicular Torsion

Locations

Country	Name	City	State
Denmark	Department of Growth and Reproduction	Copenhagen

Sponsors (1)

Lead Sponsor	Collaborator
Herlev and Gentofte Hospital

Country where clinical trial is conducted

Denmark, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Sperm concentration	Amount of motile sperm cells (* 10^6)	8-17 years after surgical intervention
Primary	Testosterone level	ng/ml	8-17 years after surgical intervention
Secondary	Semen parameters as an indicator of overall testicular exocrine function	Compared with results from control group	8-17 years after surgical intervention
Secondary	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
Secondary	MAR test result correlated to the type of surgery	MAR test of sperm cells	8-17 years after surgical intervention
Secondary	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
Secondary	Paternity as a measure of fertility	Number of kids if any.	8-17 years after surgical intervention