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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

Primary Purpose

Reduced Sperm Motility, IVF, ICSI

Status
Completed
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
Microfluidic sperm sorting chip
Density gradient
Sponsored by
Maltepe University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Reduced Sperm Motility focused on measuring Sperm, IVF, ICSI, Abnormal morphology of sperm, Astheno Teratozoospermia, Microfluidic chip

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)MaleDoes not accept healthy volunteers

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

Sites / Locations

  • MaltepeU

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

Density gradient method

Microfluidic chip

Arm Description

Sperm prepared by density gradient method

Sperm prepared by microfluidic chip method

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Full Information

First Posted
June 25, 2021
Last Updated
July 5, 2021
Sponsor
Maltepe University
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1. Study Identification

Unique Protocol Identification Number
NCT04962074
Brief Title
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
Official Title
Sperm Selection and Embryo Development: Comparison of the Density Gradient Centrifugation and Microfluidic Chip Sperm Preparation Methods
Study Type
Interventional

2. Study Status

Record Verification Date
July 2021
Overall Recruitment Status
Completed
Study Start Date
January 5, 2020 (Actual)
Primary Completion Date
September 20, 2020 (Actual)
Study Completion Date
September 20, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Maltepe University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Reduced Sperm Motility, IVF, ICSI, Astheno Teratozoospermia
Keywords
Sperm, IVF, ICSI, Abnormal morphology of sperm, Astheno Teratozoospermia, Microfluidic chip

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
22 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Density gradient method
Arm Type
Experimental
Arm Description
Sperm prepared by density gradient method
Arm Title
Microfluidic chip
Arm Type
Experimental
Arm Description
Sperm prepared by microfluidic chip method
Intervention Type
Device
Intervention Name(s)
Microfluidic sperm sorting chip
Intervention Description
Fertile Ultimate® (Koek Biotechnology, Turkey) microfluidic sperm sorting chips
Intervention Type
Device
Intervention Name(s)
Density gradient
Intervention Description
Density gradient centrifugation
Primary Outcome Measure Information:
Title
Semen parameters after sperm preparation with either method: semen volume
Description
semen volume (ml)
Time Frame
up to 7 months
Title
Semen parameters after sperm preparation with either method: sperm concentration
Description
sperm concentration (106/ml)
Time Frame
up to 7 months
Title
Semen parameters after sperm preparation with either method: total motility
Description
total motility (%)
Time Frame
up to 7 months
Title
Semen parameters after sperm preparation with either method: progressive motility
Description
progressive motility (%)
Time Frame
up to 7 months
Title
Embryo development after sperm preparation with either method
Description
Embryo development and blastocyst formation were evaluated on days 1, 3 and 5 based on the criteria reported by Veeck and Zaninovic, 2003
Time Frame
up to 7 months

10. Eligibility

Sex
Male
Gender Based
Yes
Gender Eligibility Description
Split semen samples from the same population of infertile men with astheno-teratozoospermia were used to fertilize the mature sibling oocytes.
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Facility Information:
Facility Name
MaltepeU
City
Istanbul
Country
Turkey

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

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

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