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

IVF Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04962074
• Other study ID #: 2019
• Status: Completed
• Phase: N/A
• Start date: January 5, 2020
• Est. completion date: September 20, 2020

Study information

• Verified date: July 2021
• Source: Maltepe University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 22
• Est. completion date: September 20, 2020
• Est. primary completion date: September 20, 2020
• Accepts healthy volunteers: No
• Gender: Male
• Age group: N/A and older

Eligibility

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

Related Conditions & MeSH terms

• Asthenozoospermia
• ICSI
• IVF
• Teratozoospermia

Intervention

Device:
• Microfluidic sperm sorting chip
Fertile Ultimate® (Koek Biotechnology, Turkey) microfluidic sperm sorting chips
• Density gradient
Density gradient centrifugation

Locations

Country	Name	City	State
Turkey	MaltepeU	Istanbul

Sponsors (1)

Lead Sponsor	Collaborator
Maltepe University

Country where clinical trial is conducted

Turkey, 

Outcome

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