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

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT02932865

Acronym

SemiFluid

Enrollment

120

Registered

2016-10-13

Start date

2016-11-30

Completion date

2023-11-30

Last updated

2023-11-15

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Infertility, Male

Keywords

azoospermia, male fertility, MD-TESE, miRNA, piRNA, male infertility

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.

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.

Interventions

None listed

Study design

Observational model

CASE_CONTROL

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

MALE

Age

18 Years to 60 Years

Healthy volunteers

Yes

Inclusion criteria

* Ability to produce semen sample

Exclusion criteria

* Cognitive impairment * Inadequate language skills for informed consent

Design outcomes

Primary

Measure	Time frame
miRNA and piRNA according to sperm recovery in MD-TESE	Two years

Secondary

Measure	Time frame
Assess miRNA and pRNA changes with hormonal treatment	two years

Other

Measure	Time frame
Describe miRNA and piRNa levels in seminal plasma of unselected men	two years

Countries

Finland

Outcome results