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NCT Number: NCT04962074

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

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.

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Key information

Conditions

Reduced Sperm Motility Astheno Teratozoospermia Asthenozoospermia Genital Diseases Genital Diseases, Male ICSI IVF Infertility Infertility, Male Male Urogenital Diseases Urogenital Diseases

Sex eligibility

Male

Study type

Interventional

Phase

Not applicable

Primary location

MaltepeU

Istanbul, Turkey (Türkiye)

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Microfluidic sperm sorting chip

Device

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

Density gradient

Device

Density gradient centrifugation

Primary outcomes

  1. Semen parameters after sperm preparation with either method: semen volume

    Time frame: up to 7 months

    semen volume (ml)

  2. Semen parameters after sperm preparation with either method: sperm concentration

    Time frame: up to 7 months

    sperm concentration (106/ml)

  3. Semen parameters after sperm preparation with either method: total motility

    Time frame: up to 7 months

    total motility (%)

  4. Semen parameters after sperm preparation with either method: progressive motility

    Time frame: up to 7 months

    progressive motility (%)

  5. Embryo development after sperm preparation with either method

    Time frame: 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

Sponsors and collaborators

Lead sponsor

Maltepe University

Other

Registry information

Official study title

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

Important dates

Study start
2020
Primary completion
2020
Study completion
2020
First posted
Jul 14, 2021
Registry last updated
Jul 14, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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