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

Sponsor

Gazi University (Other)

Overall Status

Completed

CT.gov ID

NCT01859520

Collaborator

(none)

Enrollment

Arm

Duration (Months)

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Male Infertility Unexplained Infertility	Procedure: swim-up, density gradient sperm preparation techniques	N/A

Study Design

Study Type:

Interventional

Actual Enrollment :

65 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Diagnostic

Official Title:

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

Study Start Date :

Jul 1, 2012

Actual Primary Completion Date :

Oct 1, 2012

Actual Study Completion Date :

Dec 1, 2012

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Swim up, density gradient swim-up and density gradient sperm preparation techniques in male factor infertility and unexplained infertility groups	Procedure: swim-up, density gradient sperm preparation techniques 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.

Arm

Intervention/Treatment

Experimental: Swim up, density gradient

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

Procedure: swim-up, density gradient sperm preparation techniques

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.

Outcome Measures

Primary Outcome Measures

The change in the rate of DNA fragmentation of spermatozoa after sperm preparation with either swim-up or density gradient techniques. [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.

Eligibility Criteria

Criteria

Ages Eligible for Study:

20 Years to 45 Years

Sexes Eligible for Study:

Male

Accepts 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

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

Gazi University

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