NCT04962074

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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
22

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jan 2020

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

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

January 5, 2020

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 20, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 20, 2020

Completed
9 months until next milestone

First Submitted

Initial submission to the registry

June 25, 2021

Completed
19 days until next milestone

First Posted

Study publicly available on registry

July 14, 2021

Completed
Last Updated

July 14, 2021

Status Verified

July 1, 2021

Enrollment Period

9 months

First QC Date

June 25, 2021

Last Update Submit

July 5, 2021

Conditions

Reduced Sperm MotilityIVFICSIAstheno Teratozoospermia

Keywords

SpermIVFICSIAbnormal morphology of spermAstheno TeratozoospermiaMicrofluidic chip

Outcome Measures

Primary Outcomes (5)

  • Semen parameters after sperm preparation with either method: semen volume

    semen volume (ml)

    up to 7 months

  • Semen parameters after sperm preparation with either method: sperm concentration

    sperm concentration (106/ml)

    up to 7 months

  • Semen parameters after sperm preparation with either method: total motility

    total motility (%)

    up to 7 months

  • Semen parameters after sperm preparation with either method: progressive motility

    progressive motility (%)

    up to 7 months

  • 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

    up to 7 months

Study Arms (2)

Density gradient method

EXPERIMENTAL

Sperm prepared by density gradient method

Device: Density gradient

Microfluidic chip

EXPERIMENTAL

Sperm prepared by microfluidic chip method

Device: Microfluidic sperm sorting chip

Interventions

Microfluidic sperm sorting chipDEVICE

Fertile Ultimate® (Koek Biotechnology, Turkey) microfluidic sperm sorting chips

Microfluidic chip
Density gradientDEVICE

Density gradient centrifugation

Density gradient method

Eligibility Criteria

Sexmale(Gender-based eligibility)
Gender Eligibility DetailsSplit semen samples from the same population of infertile men with astheno-teratozoospermia were used to fertilize the mature sibling oocytes.
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • MI oocytes

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

MaltepeU

Istanbul, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Asthenozoospermia

Interventions

Centrifugation, Density Gradient

Condition Hierarchy (Ancestors)

Infertility, MaleGenital Diseases, MaleGenital DiseasesUrogenital DiseasesInfertilityMale Urogenital Diseases

Intervention Hierarchy (Ancestors)

UltracentrifugationCentrifugationInvestigative TechniquesChemistry Techniques, Analytical

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 25, 2021

First Posted

July 14, 2021

Study Start

January 5, 2020

Primary Completion

September 20, 2020

Study Completion

September 20, 2020

Last Updated

July 14, 2021

Record last verified: 2021-07

Data Sharing

IPD Sharing
Will not share

Locations

TU(1)