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
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
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
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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