HPV as a Possible Cause of Azoospermia

HPV in Testis Tissue Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02329275
• Other study ID #: Lab.Reprod.Biol.- Odense.02
• Status: Completed
• Start date: December 2014
• Est. completion date: March 2018

Study information

• Verified date: January 2019
• Source: Odense University Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

Azoospermia is found in 5-20% of all men suffering from infertility, and in more than 20% azoospermia remains unexplained. The investigators suggest, that HPV may be an etiological factor in azoospermia and reduced sperm production.

The investigators plan to examine the occurrence of HPV in testicular tissue from 100 azoospermic men and to compare with the HPV occurrence in testicular tissue from a control group of 40 normal, healthy men undergoing vasectomy. Since HPV, in a recent Danish study, was detected on sperm in 16% of 188 randomly selected semen donors, the investigators also plan to examine the occurrence of HPV on sperm ejaculated during the last week before vasectomy. If HPV should be found in testicular tissue from men belonging to the control group, it will be highly relevant to compare with the HPV occurrence on sperm ejaculated from the men in concern.

A Linear Array HPV Genotyping Kit from Roche will be used for detection of HPV in testicular tissue and ejaculates. In total, with this test kit 37 HPV genotypes are examined for, including 13 high risk types.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 140
• Est. completion date: March 2018
• Est. primary completion date: December 2017
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Men with azoospermia (Group 1) and proven fertile men undergoing vasectomy (Group 2)

Exclusion Criteria:

• Men with testicular abnormalities (Group 2)

• Men who do not understand the purpose and possible consequences of the study (both groups)

Related Conditions & MeSH terms

• HPV in Testis Tissue

Intervention

Procedure:
• Testicular biopsy

Locations

Country	Name	City	State
Denmark	Fertility Clinic, Odense University Hospital	Odense

Sponsors (1)

Lead Sponsor	Collaborator
Odense University Hospital

Country where clinical trial is conducted

Denmark, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	HPV DNA in testicular tissue	In tissue from both azoospermic and proven fertile men	Two years
Secondary	HPV DNA in ejaculates	In ejaculates from the proven fertile men	Two years