Clinical trial NCT04137965: Testicular Function After Testicular Torsion
Official title: Testicular Function After Testicular Torsion
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Testicular Torsion
Spermatic Cord Torsion
Keywords: Fertility
Testicular Torsion
Testicular function
Lead sponsor: Herlev and Gentofte Hospital
Sponsor class: OTHER
First posted: 2019-10-24
Enrollment: 140
Sex: MALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: CROSS_SECTIONAL
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.

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

Eligibility criteria: 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

Primary outcomes:
measure: Sperm concentration
timeFrame: 8-17 years after surgical intervention
measure: Testosterone level
timeFrame: 8-17 years after surgical intervention
Secondary outcomes:
measure: Semen parameters as an indicator of overall testicular exocrine function
timeFrame: 8-17 years after surgical intervention
measure: Hormone level as an indicator of testicular endocrine function
timeFrame: 8-17 years after surgical intervention
measure: MAR test result correlated to the type of surgery
timeFrame: 8-17 years after surgical intervention
measure: Difference in sperm morphology and motility correlated to the type of surgery and compared to control group
timeFrame: 8-17 years after surgical intervention
measure: Paternity as a measure of fertility
timeFrame: 8-17 years after surgical intervention
Other outcomes:
Locations:
city: Copenhagen
country: Denmark
facility: Department of Growth and Reproduction
Study officials:
affiliation: Herlev and Gentofte Hospital
name: Jens Sønksen, Professor
role: STUDY_DIRECTOR
References: