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

T

Turku University Hospital (TYKS)

Status

Completed

Conditions

Infertility, Male

Study type

Observational

Funder types

Other

Identifiers

NCT02932865
SemiFluid

Details and patient eligibility

About

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.

Full 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.

Enrollment

120 patients

Sex

Male

Ages

18 to 60 years old

Volunteers

Accepts Healthy Volunteers

Inclusion criteria

  • Ability to produce semen sample

Exclusion criteria

  • Cognitive impairment
  • Inadequate language skills for informed consent

Trial design

120 participants in 3 patient groups

MD-TESE (A)
Description:
Azoospermic men, MD-TESE operation (standard treatment). Semen sample, serum sample and physical examination with testicular ultrasound.
Subfertile men (B)
Description:
Subfertile men receiving medication (standard treatment). Semen sample, serum sample and physical examination with testicular ultrasound.
Control (C)
Description:
Control group, men scheduled for semen analysis. Semen sample, serum sample and physical examination with testicular ultrasound.

Trial contacts and locations

1

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Central trial contact

Antti Perheentupa, MD, PhD; Rauni klami, MD

Data sourced from clinicaltrials.gov

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