A Novel Sperm Selection Method Provides Advantages Over Conventional Approaches

August 7, 2024 updated by: Liliana Berenice Ramírez Domínguez, Center of Innovation Technology & Reproductive Medicine

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

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

115

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Mexico
      • Mexico City, Mexico, 11520
        • CITMER

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult

Accepts Healthy Volunteers

Yes

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Density Gradient Centrifugation
A density gradient of is formed in 15 mL conical tubes as follows: 1 mL of lower gradient (90%) medium is placed at the bottom, 1 mL of upper (45%) gradient medium is placed on top of the bottom layer, and 1 mL of semen sample is layered above the gradient. Tubes are centrifuged for 10 minutes at 1,200 x g at room temperature. The pellet containing the viable cells is separated, resuspended in 1 mL of HTF-HEPES medium, and centrifuged at room temperature for 10 minutes at 1,200 x g to remove traces of gradient medium. The supernatant is then removed, 500 µL of HTF-HEPES medium are added to the sperm pellet, carefully mixed, and cells are counted
Device: Density Gradient Centrifugation
Sperm separation with density gradients
Experimental: CA0 chamber
One mL of semen is placed in the base, then the intermediate part is placed on the base, taking care to match the notches that assemble both parts. Subsequently, 900 µL of HTF-HEPES medium are placed in the intermediate part, the cover is placed and the device is incubated at 37°C for 30 minutes. Subsequently, a 500-µL aliquot is recovered and cells are counted
Device: CA0 chamber
Sperm separation with a novel device

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Within 2 hours from the sperm collection
Sperm intracellular Calcium
Time Frame: Within 2 hours from the sperm collection
Evaluation of the progesterone-induced intracellular calcium fluorescent peaks after sperm selection
Within 2 hours from the sperm collection
Sperm concentration
Time Frame: Within 2 hours from the sperm collection
Assessment of sperm count after sperm separation
Within 2 hours from the sperm collection
Sperm motility
Time Frame: Within 2 hours from the sperm collection
Percentage of progresive, non-progressive and immotile sperm after sperm separation
Within 2 hours from the sperm collection
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
17-20 hours after insemination by IVF or ICSI

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Center of Innovation Technology & Reproductive Medicine

Collaborators

Universidad Nacional Autonoma de Mexico

Investigators

  • Principal Investigator: Claudia L Treviño, Departamento de Genética del Desarrollo y Fisiología Molecular, Instituto de Biotecnología (IBT), Universidad Nacional Autónoma de México (UNAM), Cuernavaca, Morelos, México

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 1, 2023

Primary Completion (Actual)

October 30, 2023

Study Completion (Actual)

November 15, 2023

Study Registration Dates

First Submitted

July 22, 2024

First Submitted That Met QC Criteria

August 7, 2024

First Posted (Actual)

August 9, 2024

Study Record Updates

Last Update Posted (Actual)

August 9, 2024

Last Update Submitted That Met QC Criteria

August 7, 2024

Last Verified

August 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CI-21-101

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

Share all IPD that underlie results in the resulting publications

IPD Sharing Time Frame

Starting 12 months after publication of the first resulting publication

IPD Sharing Access Criteria

Directly contact investigators

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP
  • ICF

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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