Sperm Selection and Embryo Development: Comparison of the Density Gradient Centrifugation and Microfluidic Chip Sperm Preparation Methods Sperm Selection and Embryo Development: Comparison of the Density Gradient Centrifugation and Microfluidic Chip Sperm Preparation Methods

July 5, 2021 updated by: Maltepe University

Sperm Selection and Embryo Development: Comparison of the Density Gradient Centrifugation and Microfluidic Chip Sperm Preparation Methods

Purpose: To compare the effects of the density gradient centrifugation and microfluidic chip sperm preparation methods on embryo development in a study population with astheno-teratozoospermia.

Materials and Methods: In this prospective study, the semen samples of the patients with astheno-teratozoospermia were divided into two groups for preparation with either the microfluidic or density gradient methods. Selected spermatozoa were used to fertilize the mature sibling oocytes. Semen parameters and embryo development on days 3 and 5 were assessed.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

22

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Turkey
      • Istanbul, Turkey
        • MaltepeU

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Genders Eligible for Study

Male

Description

Inclusion Criteria:

  • Infertile men with astheno-teratozoospermia
  • Women were aged from 18 to 39
  • Women had at least two mature oocytes.

Exclusion Criteria:

  • MI oocytes

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Density gradient method
Sperm prepared by density gradient method
Device: Density gradient
Density gradient centrifugation
Experimental: Microfluidic chip
Sperm prepared by microfluidic chip method
Device: Microfluidic sperm sorting chip
Fertile Ultimate® (Koek Biotechnology, Turkey) microfluidic sperm sorting chips

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Semen parameters after sperm preparation with either method: semen volume
Time Frame: up to 7 months
semen volume (ml)
up to 7 months
Semen parameters after sperm preparation with either method: sperm concentration
Time Frame: up to 7 months
sperm concentration (106/ml)
up to 7 months
Semen parameters after sperm preparation with either method: total motility
Time Frame: up to 7 months
total motility (%)
up to 7 months
Semen parameters after sperm preparation with either method: progressive motility
Time Frame: up to 7 months
progressive motility (%)
up to 7 months
Embryo development after sperm preparation with either method
Time Frame: up to 7 months
Embryo development and blastocyst formation were evaluated on days 1, 3 and 5 based on the criteria reported by Veeck and Zaninovic, 2003
up to 7 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Maltepe University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 5, 2020

Primary Completion (Actual)

September 20, 2020

Study Completion (Actual)

September 20, 2020

Study Registration Dates

First Submitted

June 25, 2021

First Submitted That Met QC Criteria

July 5, 2021

First Posted (Actual)

July 14, 2021

Study Record Updates

Last Update Posted (Actual)

July 14, 2021

Last Update Submitted That Met QC Criteria

July 5, 2021

Last Verified

July 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2019 (Chief Medical Office (CMO) Alberta Health Services)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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