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Swim up and Gradient Methods Used in Assisted Reproduction Techniques on DNA Fragmentation of Spermatozoa

Primary Purpose

Male Infertility, Unexplained Infertility

Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
swim-up, density gradient sperm preparation techniques
Sponsored by
Gazi University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Male Infertility focused on measuring Spermatozoa, DNA fragmentation, Swim-up, Density gradient

Eligibility Criteria

20 Years - 45 Years (Adult)MaleDoes not accept healthy volunteers

Inclusion Criteria:

Male factor subfertile group:

Couples of having at least two abnormal sperm analysis according to WHO criteria.

Unexplained subfertile group:

Couples with normal sperm parameters, plus females with normal ovulatory status and patent fallopian tubes by hysterosalpingography or laparoscopy.

No previous IVF or IUI attempts before the study

Exclusion Criteria:

Severe oligospermia (Sperm count < 5 Millions/ per ml) Systemic diseases or therapies influencing DNA integrity for male partner

Sites / Locations

    Arms of the Study

    Arm 1

    Arm Type

    Experimental

    Arm Label

    Swim up, density gradient

    Arm Description

    swim-up and density gradient sperm preparation techniques in male factor infertility and unexplained infertility groups

    Outcomes

    Primary Outcome Measures

    The change in the rate of DNA fragmentation of spermatozoa after sperm preparation with either swim-up or density gradient techniques.
    The change in the rate of DNA fragmented spermatozoa will be assessed before and immediately after the sperm preparation is completed, because DNA fragmentation of spermatozoa may be increased in time.

    Secondary Outcome Measures

    Full Information

    First Posted
    March 25, 2013
    Last Updated
    May 21, 2013
    Sponsor
    Gazi University
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    1. Study Identification

    Unique Protocol Identification Number
    NCT01859520
    Brief Title
    Swim up and Gradient Methods Used in Assisted Reproduction Techniques on DNA Fragmentation of Spermatozoa
    Official Title
    The Effect of Swim up and Gradient Methods Used in Assisted Reproduction Techniques on DNA Fragmentation of Spermatozoa
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    May 2013
    Overall Recruitment Status
    Completed
    Study Start Date
    July 2012 (undefined)
    Primary Completion Date
    October 2012 (Actual)
    Study Completion Date
    December 2012 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Gazi University

    4. Oversight

    Data Monitoring Committee
    No

    5. Study Description

    Brief Summary
    Sperms are prepared by sperm washing techniques before used in assisted reproductive technologies. Most commonly used sperm preparation methods are the swim up and the density gradient. Recent studies shows that the DNA integrity status of the spermatozoa is related to the success in assisted reproduction techniques. Sperm preparation methods may theoretically cause damage to sperm DNA. Therefore it is important to select the optimum method of sperm preparation causing least sperm DNA damage. Aim of our study is to investigate and compare the effect two different sperm preparation techniques on DNA fragmentation.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Male Infertility, Unexplained Infertility
    Keywords
    Spermatozoa, DNA fragmentation, Swim-up, Density gradient

    7. Study Design

    Primary Purpose
    Diagnostic
    Study Phase
    Not Applicable
    Interventional Study Model
    Single Group Assignment
    Masking
    None (Open Label)
    Allocation
    N/A
    Enrollment
    65 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Swim up, density gradient
    Arm Type
    Experimental
    Arm Description
    swim-up and density gradient sperm preparation techniques in male factor infertility and unexplained infertility groups
    Intervention Type
    Procedure
    Intervention Name(s)
    swim-up, density gradient sperm preparation techniques
    Intervention Description
    Sperms are prepared by sperm washing techniques before used in assisted reproductive technologies. Most commonly used sperm preparation methods are the swim up and the density gradient. Recent studies shows that the DNA integrity status of the spermatozoa is related to the success in assisted reproduction techniques. Sperm preparation methods may theoretically cause damage sperm DNA. Therefore it is important to select the optimum method of sperm preparation causing least sperm DNA damage. Aim of our study is to investigate and compare the effect two different sperm preparation techniques on DNA fragmentation.
    Primary Outcome Measure Information:
    Title
    The change in the rate of DNA fragmentation of spermatozoa after sperm preparation with either swim-up or density gradient techniques.
    Description
    The change in the rate of DNA fragmented spermatozoa will be assessed before and immediately after the sperm preparation is completed, because DNA fragmentation of spermatozoa may be increased in time.
    Time Frame
    DNA fragmentation assay is performed just before and immediately after the sperm preparation is completed. The time frame is within an hour.

    10. Eligibility

    Sex
    Male
    Minimum Age & Unit of Time
    20 Years
    Maximum Age & Unit of Time
    45 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: Male factor subfertile group: Couples of having at least two abnormal sperm analysis according to WHO criteria. Unexplained subfertile group: Couples with normal sperm parameters, plus females with normal ovulatory status and patent fallopian tubes by hysterosalpingography or laparoscopy. No previous IVF or IUI attempts before the study Exclusion Criteria: Severe oligospermia (Sperm count < 5 Millions/ per ml) Systemic diseases or therapies influencing DNA integrity for male partner
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Ahmet erdem, Professsor, MD
    Organizational Affiliation
    University of Gazi School of Medicine Department of Obstetrics and Gynecology
    Official's Role
    Study Director
    First Name & Middle Initial & Last Name & Degree
    Yuksel Oguz, Resident, MD
    Organizational Affiliation
    University of Gazi School Of Medicine Department of Obstetrics and Gynecology
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

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