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

Sponsor
Turku University Hospital (Other)
Overall Status
Unknown status
CT.gov ID
NCT02932865
Collaborator
Lund University Hospital (Other), University of Turku (Other)
60
Enrollment
1
Location
24
Duration (Months)
2.5
Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase

    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.

    Study Design

    Study Type:
    Observational
    Anticipated Enrollment :
    60 participants
    Observational Model:
    Case-Control
    Time Perspective:
    Prospective
    Official Title:
    Modern Analyses of the Semen in Evaluating Male Fertility and Treatment Options of Male Infertility
    Study Start Date :
    Oct 1, 2016
    Anticipated Primary Completion Date :
    Oct 1, 2018
    Anticipated Study Completion Date :
    Oct 1, 2018

    Arms and Interventions

    Arm Intervention/Treatment
    MD-TESE (A)

    Azoospermic men, MD-TESE operation (standard treatment). Semen sample, serum sample and physical examination with testicular ultrasound.
    Subfertile men (B)

    Subfertile men receiving medication (standard treatment). Semen sample, serum sample and physical examination with testicular ultrasound.
    Control (C)

    Control group, men scheduled for semen analysis. Semen sample, serum sample and physical examination with testicular ultrasound.

    Outcome Measures

    Primary Outcome Measures

    1. miRNA and piRNA according to sperm recovery in MD-TESE [Two years]

    Secondary Outcome Measures

    1. Assess miRNA and pRNA changes with hormonal treatment [two years]

    Other Outcome Measures

    1. Describe miRNA and piRNa levels in seminal plasma of unselected men [two years]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 60 Years
    Sexes Eligible for Study:
    Male
    Accepts Healthy Volunteers:
    Yes
    Inclusion Criteria:
    • Ability to produce semen sample
    Exclusion Criteria:

    • Cognitive impairment

    • Inadequate language skills for informed consent

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Turku University Hospital Turku Finland 20521

    Sponsors and Collaborators

    • Turku University Hospital
    • Lund University Hospital
    • University of Turku

    Investigators

    • Study Director: Antti Perheentupa, MD,PhD, University of Turku

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Turku University Hospital
    ClinicalTrials.gov Identifier:
    NCT02932865
    Other Study ID Numbers:
    • SemiFluid
    First Posted:
    Oct 13, 2016
    Last Update Posted:
    Oct 25, 2017
    Last Verified:
    Oct 1, 2016
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Keywords provided by Turku University Hospital
    azoospermia
    male fertility
    MD-TESE
    miRNA
    piRNA
    male infertility
    Additional relevant MeSH terms:
    Infertility
    Infertility, Male

    Study Results

    No Results Posted as of Oct 25, 2017