HPV as a Possible Cause of Azoospermia

Completed

• Conditions: HPV in Testis Tissue
• Interventions: Procedure: Testicular biopsy

• Registration Number: NCT02329275
• Lead Sponsor: Odense University Hospital

Brief 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2014-12
• Study First Submitted: 2014-12-29
• Study First Submitted QC: 2014-12-29
• Study First Posted: 2014-12-31
• Primary Completion: 2017-12
• Study Completion: 2018-03
• Status Verified: 2019-01
• Last Update Submitted: 2019-01-16
• Last Update Posted: 2019-01-17

Recruitment & Eligibility

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

Inclusion Criteria

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

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Exclusion Criteria

• Men with testicular abnormalities (Group 2)
• Men who do not understand the purpose and possible consequences of the study (both groups)

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Azoospermic men	Testicular biopsy	-
Men with proven fertility	Testicular biopsy	-

Primary Outcome Measures

Name	Time	Method
HPV DNA in testicular tissue	Two years	In tissue from both azoospermic and proven fertile men

Secondary Outcome Measures

Name	Time	Method
HPV DNA in ejaculates	Two years	In ejaculates from the proven fertile men

Trial Locations

Locations (1)

Fertility Clinic, Odense University Hospital; 🇩🇰 Odense, Denmark