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Clinical Trials/NCT02932865
NCT02932865
Completed
Not Applicable

Modern Analyses of the Semen in Evaluating Male Fertility and Treatment Options of Male Infertility

Turku University Hospital1 site in 1 country120 target enrollmentNovember 2016

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Infertility, Male
Sponsor
Turku University Hospital
Enrollment
120
Locations
1
Primary Endpoint
miRNA and piRNA according to sperm recovery in MD-TESE
Status
Completed
Last Updated
2 years ago

Overview

Brief Summary

Men are recruited to collect seminal plasma samples and serum samples from men with azoospermia, men receiving medical treatment of infertility and men attending semen analysis. MicroRNA (miRNA) and PiWi-interacting RNA (piRNA) are analyzed for all of the groups to find potential differences. Steroid hormones are analyzed by liquid chromatography-tandem mass spectrometry.

Detailed Description

Azoospermic men attending microdissection testicular sperm extraction (MD-TESE) are group A. Second group (B) is the men with poor semen quality, who are treated with aromatase inhibitor, antiestrogen or human choriogonadotropic hormone (HCG) to improve semen quality. Third group (C) consists of men submitting semen analysis. The intended number of participants is 60, 60 and 100 men, respectively. Seminal plasma and serum samples are collected and miRNA and piRNA are analyzed. Steroid hormones are analyzed by liquid chromatography-tandem mass spectrometry. The participants are given a physical examination and testicular ultrasound. The primary aim of this study is to develop a tool to better estimate the sperm recovery rate (SRR) of azoospermic men scheduled for MD-TESE. Since no data have been published presenting miRNA and piRNA levels in men with normal semen, a secondary aim is to describe the levels of miRNA and piRNA in unselected men. Third part of this study aims to find if medical treatment improving semen parameters affects miRNA ja piRNA findings.

Registry
clinicaltrials.gov
Start Date
November 2016
End Date
November 2023
Last Updated
2 years ago
Study Type
Observational
Sex
Male

Investigators

Responsible Party
Sponsor

Eligibility Criteria

Inclusion Criteria

  • Ability to produce semen sample

Exclusion Criteria

  • Cognitive impairment
  • Inadequate language skills for informed consent

Outcomes

Primary Outcomes

miRNA and piRNA according to sperm recovery in MD-TESE

Time Frame: Two years

Secondary Outcomes

  • Assess miRNA and pRNA changes with hormonal treatment(two years)

Study Sites (1)

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