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OpenTrials
Completed

NCT Number: NCT06545318

A Novel Sperm Selection Method Provides Advantages Over Conventional Approaches

The goal of this clinical trial is to know if a novel sperm selection device (CA0) has a similar performance than the standard selection method in teratozoospermic and azoospermic men. The main questions it aims to answer are:

Does the CA0 sperm selection device increases the sperm concentration? Does the CA0 sperm selection device increases the sperm motility? What are the differences in sperm membrane potential when CA0 is used? Do intracellular Calcium levels change when CA0 is used? Does CA0 increase fertilization rates? Researchers will compare CA0 to the standard of care for sperm selection (density gradient centrifugation) to see if CA0 has similar performance

Participants will:

Provide a semen sample Have their semen sample analyzed, processed and used for assisted reproduction technologies

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Key information

Conditions

Male Infertility Genital Diseases Genital Diseases, Male Infertility Infertility, Male Male Urogenital Diseases Urogenital Diseases

Age range

18 year–35 year

Sex eligibility

Male

Study type

Interventional

Phase

Not applicable

Primary location

CITMER

Mexico City, 11520, Mexico

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

  • Normozoospermic (18-35 years old) and teratozoospermic (18-60 years old) patients undergoing IVF/ICSI cyles with at least 2 days of sexual abstinence

Exclusion criteria

  • Less than 4 oocytes collected during oocyte retrieval
  • Total sperm count less than 30x10^6

Treatment and study plan

Density gradient centrifugation

Device

Sperm separation with density gradients

CA0 chamber

Device

Sperm separation with a novel device

Primary outcomes

  1. Sperm membrane potential

    Time frame: Within 2 hours from the sperm collection

    Evaluation of the KCl-induced difference of membrane potential voltage in mV, after sperm selection.

  2. Sperm intracellular Calcium

    Time frame: Within 2 hours from the sperm collection

    Evaluation of the progesterone-induced intracellular calcium fluorescent peaks after sperm selection

  3. Sperm concentration

    Time frame: Within 2 hours from the sperm collection

    Assessment of sperm count after sperm separation

  4. Sperm motility

    Time frame: Within 2 hours from the sperm collection

    Percentage of progresive, non-progressive and immotile sperm after sperm separation

  5. Fertilization rates

    Time frame: 17-20 hours after insemination by IVF or ICSI

    Determination of the rate of 2 pronucleous, 2 polar bodies zygotes after insemination

Sponsors and collaborators

Lead sponsor

Center of Innovation Technology & Reproductive Medicine

Industry

Collaborators

  • Universidad Nacional Autonoma de Mexico

Registry information

Official study title

A Novel Sperm Selection Method Provides Advantages Over Conventional Approaches: Validation Through a Clinical Pilot Study

Important dates

Study start
2023
Primary completion
2023
Study completion
2023
First posted
Aug 9, 2024
Registry last updated
Aug 9, 2024

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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