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

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Infertility, Male

Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Ability to produce semen sample Exclusion Criteria: Cognitive impairment Inadequate language skills for informed consent

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 60 Years

Sexes Eligible for Study
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Male

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| MD-TESE (A)<br>Azoospermic men, MD-TESE operation (standard treatment). Semen sample, serum sample and physical examination with testicular ultrasound. | |
| Subfertile men (B)<br>Subfertile men receiving medication (standard treatment). Semen sample, serum sample and physical examination with testicular ultrasound. | |
| Control (C)<br>Control group, men scheduled for semen analysis. Semen sample, serum sample and physical examination with testicular ultrasound. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| miRNA and piRNA according to sperm recovery in MD-TESE |  | Two years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Assess miRNA and pRNA changes with hormonal treatment |  | two years | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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azoospermia, male fertility, MD-TESE, miRNA, piRNA, male infertility