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

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

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT04962074

Enrollment

Registered

2021-07-14

Start date

2020-01-05

Completion date

2020-09-20

Last updated

2021-07-14

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Astheno Teratozoospermia, ICSI, IVF, Reduced Sperm Motility

Keywords

Sperm, IVF, ICSI, Abnormal morphology of sperm, Astheno Teratozoospermia, Microfluidic chip

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.

Interventions

DEVICEMicrofluidic sperm sorting chip

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

DEVICEDensity gradient

Density gradient centrifugation

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

SINGLE (Subject)

Eligibility

Sex/Gender

MALE

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

Design outcomes

Primary

Measure	Time frame	Description
Semen parameters after sperm preparation with either method: semen volume	up to 7 months	semen volume (ml)
Semen parameters after sperm preparation with either method: sperm concentration	up to 7 months	sperm concentration (106/ml)
Semen parameters after sperm preparation with either method: total motility	up to 7 months	total motility (%)
Semen parameters after sperm preparation with either method: progressive motility	up to 7 months	progressive motility (%)
Embryo development after sperm preparation with either method	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

Countries

Turkey (Türkiye)

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026