CClinicalTrials.gg
CompletedNCT01859520Updated May 22, 2013

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

An interventional study of swim-up, density gradient sperm preparation techniques in Male Infertility and Unexplained Infertility, sponsored by Gazi University. Completed. Open to male participants aged 20 Years to 45 Years. Per ClinicalTrials.gov, last updated 2013-05-22.

Sponsored by Gazi University · Not applicable, Interventional, and Diagnostic

Phase
Not applicable
Study type
Interventional
Enrollment
65
Allocation
Not applicable
Ages
20 Years to 45 Years
Sex
Male
01

Study 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.

02

Conditions studied

  • Male Infertility
  • Unexplained Infertility

Keywords

  • Spermatozoa
  • DNA fragmentation
  • Swim-up
  • Density gradient
03

In context

Infertility

2,506 studies on the registry are indexed under Infertility; 407 are open to participants now.

This study's enrollment of 65 is below the median of 120 across 1,698 interventional studies indexed under Infertility.

Browse Infertility studies →

Lead sponsor

Gazi University is the lead sponsor of 531 studies on the registry; 99 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
20 Years to 45 Years
Sexes eligible
Male
Accepts healthy volunteers
No

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

Exclusion Criteria:

Severe oligospermia (Sperm count \< 5 Millions/ per ml) Systemic diseases or therapies influencing DNA integrity for male partner

05

Study design

Phase
Not applicable
Primary purpose
Diagnostic
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
65 participants (actual)

Study arms

  • 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

Interventions

  • Procedureswim-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.

06

What researchers measure

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.

    Time frame: DNA fragmentation assay is performed just before and immediately after the sperm preparation is completed. The time frame is within an hour.

07

Study locations

No study locations are listed for this record.

08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on May 22, 2013, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT01859520
Lead sponsor
Gazi University
Responsible party
Prof Ahmet ERDEM, MD (Professor of Obstetrics and Gynecology, Gazi University) — Principal investigator
First posted
May 22, 2013
Start date
Jul 2012
Primary completion
Oct 2012
Completion
Dec 2012
Last update
May 22, 2013

Study contacts

Ahmet erdem, Professsor, MD
study director · University of Gazi School of Medicine Department of Obstetrics and Gynecology
Yuksel Oguz, Resident, MD
principal investigator · University of Gazi School Of Medicine Department of Obstetrics and Gynecology

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in May 2013. You cannot join it, but the record below documents what was studied.

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