NCT02932865

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
120

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Nov 2016

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

October 12, 2016

Completed
1 day until next milestone

First Posted

Study publicly available on registry

October 13, 2016

Completed
19 days until next milestone

Study Start

First participant enrolled

November 1, 2016

Completed
6.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2023

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2023

Completed
Last Updated

November 15, 2023

Status Verified

November 1, 2023

Enrollment Period

6.9 years

First QC Date

October 12, 2016

Last Update Submit

November 14, 2023

Conditions

Infertility, Male

Keywords

azoospermiamale fertilityMD-TESEmiRNApiRNAmale infertility

Outcome Measures

Primary Outcomes (1)

  • miRNA and piRNA according to sperm recovery in MD-TESE

    Two years

Secondary Outcomes (1)

  • Assess miRNA and pRNA changes with hormonal treatment

    two years

Other Outcomes (1)

  • Describe miRNA and piRNa levels in seminal plasma of unselected men

    two years

Study Arms (3)

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.

Eligibility Criteria

Age18 Years - 60 Years
Sexmale
Healthy VolunteersYes
Age GroupsAdult (18-64)
Sampling MethodProbability Sample
Study Population

Men contacting the fertility clinic in Turku University Hospital

You may qualify if:

  • Ability to produce semen sample

You may not qualify if:

  • Cognitive impairment
  • Inadequate language skills for informed consent

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Turku University Hospital

Turku, 20521, Finland

Location

Biospecimen

Retention: SAMPLES WITH DNA

Semen sample Serum sample

MeSH Terms

Conditions

Infertility, MaleAzoospermia

Condition Hierarchy (Ancestors)

Genital Diseases, MaleGenital DiseasesUrogenital DiseasesInfertilityMale Urogenital Diseases

Study Officials

  • Antti Perheentupa, MD,PhD

    University of Turku

    STUDY DIRECTOR

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER GOV
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 12, 2016

First Posted

October 13, 2016

Study Start

November 1, 2016

Primary Completion

October 1, 2023

Study Completion

November 1, 2023

Last Updated

November 15, 2023

Record last verified: 2023-11

Data Sharing

IPD Sharing
Will not share

Locations

FI(1)