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Completed

NCT Number: NCT02932865

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

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.

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Key information

Conditions

Infertility, Male Azoospermia Genital Diseases Genital Diseases, Male Infertility Male Urogenital Diseases Urogenital Diseases

Age range

18 year–60 year

Sex eligibility

Male

Study type

Observational

Primary location

Turku University Hospital

Turku, 20521, Finland

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

  • Ability to produce semen sample

Exclusion criteria

  • Cognitive impairment
  • Inadequate language skills for informed consent

Treatment and study plan

Primary outcomes

  1. miRNA and piRNA according to sperm recovery in MD-TESE

    Time frame: Two years

Secondary outcomes

  1. Assess miRNA and pRNA changes with hormonal treatment

    Time frame: two years

Other outcomes

  1. Describe miRNA and piRNa levels in seminal plasma of unselected men

    Time frame: two years

Sponsors and collaborators

Lead sponsor

Turku University Hospital

Other Gov

Collaborators

  • Lund University Hospital
  • University of Turku

Registry information

Acronym: SemiFluid

Important dates

Study start
2016
Primary completion
2023
Study completion
2023
First posted
Oct 13, 2016
Registry last updated
Nov 15, 2023

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.

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