Back to resultsSwim 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
About this trial
This is an interventional diagnostic trial for Male Infertility focused on measuring Spermatozoa, DNA fragmentation, Swim-up, Density gradient
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
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
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
Learn more about this trial
Swim up and Gradient Methods Used in Assisted Reproduction Techniques on DNA Fragmentation of Spermatozoa
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