HPV as a Possible Cause of Azoospermia

NCT02329275 | Completed DMC

• 1 other identifier: Lab.Reprod.Biol.- Odense.02
• Study Type: observational
• Target: 140
• Locations: 1 country
• Sites: 1

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.

Conditions

HPV in Testis Tissue

Outcome Measures

Primary Outcomes (1)

• HPV DNA in testicular tissue

  In tissue from both azoospermic and proven fertile men

  Two years

Secondary Outcomes (1)

• HPV DNA in ejaculates

  Two years

Study Arms (2)

Azoospermic men

Procedure: Testicular biopsy

Men with proven fertility

Procedure: Testicular biopsy

Interventions

Testicular biopsy PROCEDURE

Azoospermic men; Men with proven fertility

Eligibility Criteria

• Age: 18 Years+
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Group 1: Unselected azoospermic men referred to the fertility clinic Group 2: Proven fertile men referred for vasectomy

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Odense University Hospital: lead

Study Sites (1)

Fertility Clinic, Odense University Hospital

Odense, 5000, Denmark

Location

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor, Consultant, Ph.D.

Study Record Dates

• First Submitted: December 29, 2014
• First Posted: December 31, 2014
• Study Start: December 1, 2014
• Primary Completion: December 1, 2017
• Study Completion: March 1, 2018
• Last Updated: January 17, 2019

Record last verified: 2019-01

Locations

DK (1)