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

Male Infertility Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01859520
• Other study ID #: Gazi University 01/2011-110
• Status: Completed
• Phase: N/A
• First received: March 25, 2013
• Last updated: May 21, 2013
• Start date: July 2012
• Est. completion date: December 2012

Study information

• Verified date: May 2013
• Source: Gazi University
• Contact: n/a
• Is FDA regulated: No
• Health authority: Turkey: Ethics Committee
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 65
• Est. completion date: December 2012
• Est. primary completion date: October 2012
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 20 Years to 45 Years

Eligibility

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 Design

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Diagnostic

Related Conditions & MeSH terms

• Infertility
• Infertility, Male
• Male Infertility
• Unexplained Infertility

Intervention

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.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Gazi University

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	No