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

Infertility, Male Clinical Trial

— SemiFluid  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02932865
• Other study ID #: SemiFluid
• Status: Completed
• Start date: November 2016
• Est. completion date: November 2023

Study information

• Verified date: November 2023
• Source: Turku University Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 120
• Est. completion date: November 2023
• Est. primary completion date: October 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 18 Years to 60 Years

Eligibility

Inclusion Criteria:

• Ability to produce semen sample

Exclusion Criteria:

• Cognitive impairment

• Inadequate language skills for informed consent

Related Conditions & MeSH terms

• Infertility
• Infertility, Male

Locations

Country	Name	City	State
Finland	Turku University Hospital	Turku

Sponsors (3)

Lead Sponsor	Collaborator
Turku University Hospital	Lund University Hospital, University of Turku

Country where clinical trial is conducted

Finland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Describe miRNA and piRNa levels in seminal plasma of unselected men		two years
Primary	miRNA and piRNA according to sperm recovery in MD-TESE		Two years
Secondary	Assess miRNA and pRNA changes with hormonal treatment		two years