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NCT02932865 Clinical Trial

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

Infertility, Male Clinical Trial

— SemiFluid  

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

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT02932865
Other study ID # SemiFluid
Secondary ID
Status Completed
Phase
First received
Last updated
Start date November 2016
Est. completion date November 2023

Study information
Verified date November 2023
Source Turku University Hospital
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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.

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.

Recruitment information / eligibility
Status Completed
Enrollment 120
Est. completion date November 2023
Est. primary completion date October 2023
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Male
Age group 18 Years to 60 Years
Eligibility Inclusion Criteria: - Ability to produce semen sample Exclusion Criteria: - Cognitive impairment - Inadequate language skills for informed consent

Study Design

Related Conditions & MeSH terms

Locations
Country Name City State
Finland Turku University Hospital Turku

Sponsors (3)
Lead Sponsor Collaborator
Turku University Hospital Lund University Hospital, University of Turku

Country where clinical trial is conducted

Finland, 

Outcome
Type Measure Description Time frame Safety issue
Other Describe miRNA and piRNa levels in seminal plasma of unselected men two years
Primary miRNA and piRNA according to sperm recovery in MD-TESE Two years
Secondary Assess miRNA and pRNA changes with hormonal treatment two years
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