- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01859520
Swim up and Gradient Methods Used in Assisted Reproduction Techniques on DNA Fragmentation of Spermatozoa
The Effect of Swim up and Gradient Methods Used in Assisted Reproduction Techniques on DNA Fragmentation of Spermatozoa
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Diagnostic
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Swim up, density gradient
swim-up and density gradient sperm preparation techniques in male factor infertility and unexplained infertility groups
|
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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
The change in the rate of DNA fragmentation of spermatozoa after sperm preparation with either swim-up or density gradient techniques.
Time Frame: DNA fragmentation assay is performed just before and immediately after the sperm preparation is completed. The time frame is within an hour.
|
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.
|
DNA fragmentation assay is performed just before and immediately after the sperm preparation is completed. The time frame is within an hour.
|
Collaborators and Investigators
Sponsor
Investigators
- Study Director: Ahmet erdem, Professsor, MD, University of Gazi School Of Medicine Department of Obstetrics and Gynecology
- Principal Investigator: Yuksel Oguz, Resident, MD, University of Gazi School Of Medicine Department of Obstetrics and Gynecology
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- Gazi University 01/2011-110
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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