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CompletedNCT02932865SemiFluidUpdated Nov 15, 2023

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

An observational study in Infertility, Male, sponsored by Turku University Hospital. Completed at 1 site in Finland. Open to male participants aged 18 Years to 60 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2023-11-15.

Sponsored by Turku University Hospital · Observational

Study type
Observational
Model
Case-control
Time perspective
Prospective
Enrollment
120
Ages
18 Years to 60 Years
Sex
Male
01

Study 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.

Read the 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.

02

Conditions studied

  • Infertility, Male

Keywords

  • azoospermia
  • male fertility
  • MD-TESE
  • miRNA
  • piRNA
  • male infertility
03

In context

Infertility

2,506 studies on the registry are indexed under Infertility; 407 are open to participants now.

This study's enrollment of 120 is below the median of 200 across 714 observational studies indexed under Infertility.

Browse Infertility studies →

Lead sponsor

Turku University Hospital is the lead sponsor of 280 studies on the registry; 65 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 60 Years
Sexes eligible
Male
Accepts healthy volunteers
Yes
Sampling method
Probability sample

Study population

Men contacting the fertility clinic in Turku University Hospital

Inclusion criteria

  • Ability to produce semen sample

Exclusion criteria

Exclusion Criteria:

  • Cognitive impairment
  • Inadequate language skills for informed consent
05

Study design

Observational model
Case-control
Time perspective
Prospective
Enrollment
120 participants (actual)
Patient registry
No
Biospecimen retention
Samples with dna

Groups and cohorts

  • 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.

06

What researchers measure

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

07

Study locations

1 site
  • Turku University Hospital
    Turku, 20521, Finland
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Nov 15, 2023, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT02932865
Lead sponsor
Turku University Hospital
Collaborators
Lund University Hospital, University of Turku
Responsible party
Sponsor
First posted
Oct 13, 2016
Start date
Nov 2016
Primary completion
Oct 2023
Completion
Nov 2023
Last update
Nov 15, 2023

Study contacts

Antti Perheentupa, MD,PhD
study director · University of Turku

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Nov 2023. You cannot join it, but the record below documents what was studied.

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