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

Study Status: Recruiting
Recruit Status: Recruiting
Study Type: Observational

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

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 Summary:

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.

Sponsor: Turku University Hospital

Current Primary Outcome: miRNA and piRNA according to sperm recovery in MD-TESE [ Time Frame: Two years ]

Original Primary Outcome: Same as current

Current Secondary Outcome: Assess miRNA and pRNA changes with hormonal treatment [ Time Frame: two years ]

Original Secondary Outcome: Same as current

Information By: Turku University Hospital

Dates:
Date Received: October 12, 2016
Date Started: October 2016
Date Completion: October 2018
Last Updated: October 12, 2016
Last Verified: October 2016