NCT01859520

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

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
65

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jul 2012

Shorter than P25 for not_applicable

Status
completed

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

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2012

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2012

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

March 25, 2013

Completed
2 months until next milestone

First Posted

Study publicly available on registry

May 22, 2013

Completed
Last Updated

May 22, 2013

Status Verified

May 1, 2013

Enrollment Period

3 months

First QC Date

March 25, 2013

Last Update Submit

May 21, 2013

Conditions

Keywords

SpermatozoaDNA fragmentationSwim-upDensity gradient

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

EXPERIMENTAL

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

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.

Swim up, density gradient

Eligibility Criteria

Age20 Years - 45 Years
Sexmale
Healthy VolunteersNo
Age GroupsAdult (18-64)

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

MeSH Terms

Conditions

Infertility, Male

Condition Hierarchy (Ancestors)

Genital Diseases, MaleGenital DiseasesUrogenital DiseasesInfertilityMale Urogenital Diseases

Study Officials

  • Ahmet erdem, Professsor, MD

    University of Gazi School of Medicine Department of Obstetrics and Gynecology

    STUDY DIRECTOR
  • Yuksel Oguz, Resident, MD

    University of Gazi School Of Medicine Department of Obstetrics and Gynecology

    PRINCIPAL INVESTIGATOR

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