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
1 other identifier
interventional
65
0 countries
N/A
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Jul 2012
Shorter than P25 for not_applicable
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
July 1, 2012
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 1, 2012
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2012
CompletedFirst Submitted
Initial submission to the registry
March 25, 2013
CompletedFirst Posted
Study publicly available on registry
May 22, 2013
CompletedMay 22, 2013
May 1, 2013
3 months
March 25, 2013
May 21, 2013
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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.
DNA fragmentation assay is performed just before and immediately after the sperm preparation is completed. The time frame is within an hour.
Study Arms (1)
Swim up, density gradient
EXPERIMENTALswim-up and density gradient sperm preparation techniques in male factor infertility and unexplained infertility groups
Interventions
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.
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- Severe oligospermia (Sperm count \< 5 Millions/ per ml) Systemic diseases or therapies influencing DNA integrity for male partner
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Gazi Universitylead
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- 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 Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NA
- Masking
- NONE
- Purpose
- DIAGNOSTIC
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Professor of Obstetrics and Gynecology
Study Record Dates
First Submitted
March 25, 2013
First Posted
May 22, 2013
Study Start
July 1, 2012
Primary Completion
October 1, 2012
Study Completion
December 1, 2012
Last Updated
May 22, 2013
Record last verified: 2013-05