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OpenTrials
Completed

NCT Number: NCT02329275

HPV as a Possible Cause of Azoospermia

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.

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Key information

Age range

18 year and older

Sex eligibility

Male

Study type

Observational

Primary location

Fertility Clinic, Odense University Hospital

Odense, 5000, Denmark

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

Testicular biopsy

Procedure

Primary outcomes

  1. HPV DNA in testicular tissue

    Time frame: Two years

    In tissue from both azoospermic and proven fertile men

Secondary outcomes

  1. HPV DNA in ejaculates

    Time frame: Two years

    In ejaculates from the proven fertile men

Sponsors and collaborators

Lead sponsor

Odense University Hospital

Other

Registry information

Important dates

Study start
2014
Primary completion
2017
Study completion
2018
First posted
Dec 31, 2014
Registry last updated
Jan 17, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.