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Trial record 9 of 396 for:    Recruiting, Not yet recruiting, Available Studies | "Infertility"

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

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ClinicalTrials.gov Identifier: NCT02932865
Recruitment Status : Recruiting
First Posted : October 13, 2016
Last Update Posted : October 25, 2017
Sponsor:
Collaborators:
Lund University Hospital
University of Turku
Information provided by (Responsible Party):
Turku University Hospital

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.

Condition or disease
Infertility, Male

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.


Study Type : Observational
Estimated Enrollment : 60 participants
Observational Model: Case-Control
Time Perspective: Prospective
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


Group/Cohort
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.



Primary Outcome Measures :
  1. miRNA and piRNA according to sperm recovery in MD-TESE [ Time Frame: Two years ]

Secondary Outcome Measures :
  1. Assess miRNA and pRNA changes with hormonal treatment [ Time Frame: two years ]

Other Outcome Measures:
  1. Describe miRNA and piRNa levels in seminal plasma of unselected men [ Time Frame: two years ]

Biospecimen Retention:   Samples With DNA
Semen sample Serum sample


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Ages Eligible for Study:   18 Years to 60 Years   (Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
Sampling Method:   Probability Sample
Study Population
Men contacting the fertility clinic in Turku University Hospital
Criteria

Inclusion Criteria:

  • Ability to produce semen sample

Exclusion Criteria:

  • Cognitive impairment
  • Inadequate language skills for informed consent

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02932865


Contacts
Contact: Rauni klami, MD 358407286874 rauni.klami@tyks.fi
Contact: Antti Perheentupa, MD, PhD +358445349025 antper@utu.fi

Locations
Finland
Turku University Hospital Recruiting
Turku, Finland, 20521
Contact: Rauni Klami, MD    +358407286874    rauni.klami@tyks.fi   
Contact: Antti Perheentupa, MD, PhD    +358445349025      
Sponsors and Collaborators
Turku University Hospital
Lund University Hospital
University of Turku
Investigators
Study Director: Antti Perheentupa, MD,PhD University of Turku

Responsible Party: Turku University Hospital
ClinicalTrials.gov Identifier: NCT02932865     History of Changes
Other Study ID Numbers: SemiFluid
First Posted: October 13, 2016    Key Record Dates
Last Update Posted: October 25, 2017
Last Verified: October 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Keywords provided by Turku University Hospital:
azoospermia
male fertility
MD-TESE
miRNA
piRNA
male infertility

Additional relevant MeSH terms:
Infertility
Infertility, Male
Genital Diseases, Male
Genital Diseases, Female