Modern Analyses of the Semen in Evaluating Male Fertility and Treatment Options of Male Infertility (SemiFluid)
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT02932865|
Recruitment Status : Recruiting
First Posted : October 13, 2016
Last Update Posted : October 25, 2017
|Condition or disease|
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.
|Study Type :||Observational|
|Estimated Enrollment :||60 participants|
|Official Title:||Modern Analyses of the Semen in Evaluating Male Fertility and Treatment Options of Male Infertility|
|Study Start Date :||October 2016|
|Estimated Primary Completion Date :||October 2018|
|Estimated Study Completion Date :||October 2018|
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 group, men scheduled for semen analysis. Semen sample, serum sample and physical examination with testicular ultrasound.
- miRNA and piRNA according to sperm recovery in MD-TESE [ Time Frame: Two years ]
- Assess miRNA and pRNA changes with hormonal treatment [ Time Frame: two years ]
- Describe miRNA and piRNa levels in seminal plasma of unselected men [ Time Frame: two years ]
Biospecimen Retention: Samples With DNA
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02932865
|Contact: Rauni klami, MDfirstname.lastname@example.org|
|Contact: Antti Perheentupa, MD, PhDemail@example.com|
|Turku University Hospital||Recruiting|
|Turku, Finland, 20521|
|Contact: Rauni Klami, MD +358407286874 firstname.lastname@example.org|
|Contact: Antti Perheentupa, MD, PhD +358445349025|
|Study Director:||Antti Perheentupa, MD,PhD||University of Turku|