A Novel Sperm Selection Method Provides Advantages Over Conventional Approaches

Not Applicable

Completed

• Conditions: Male Infertility
• Interventions: Device: Density Gradient Centrifugation; Device: CA0 chamber

• Registration Number: NCT06545318
• Lead Sponsor: Center of Innovation Technology & Reproductive Medicine

Brief Summary

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

Detailed Description

Not available

Basic Information
|
Recruitment & Eligibility
|
Study & Design
|
Trial Locations

Study Timeline

• Study Start: 2023-01-01
• Primary Completion: 2023-10-30
• Study Completion: 2023-11-15
• Study First Submitted: 2024-07-22
• Status Verified: 2024-08
• Study First Submitted QC: 2024-08-07
• Last Update Submitted: 2024-08-07
• Study First Posted: 2024-08-09
• Last Update Posted: 2024-08-09

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 115

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

Read More

Exclusion Criteria

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

Read More

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Density Gradient Centrifugation	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
CA0 chamber	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

Primary Outcome Measures

Name	Time	Method
Sperm intracellular Calcium	Within 2 hours from the sperm collection	Evaluation of the progesterone-induced intracellular calcium fluorescent peaks after sperm selection
Sperm motility	Within 2 hours from the sperm collection	Percentage of progresive, non-progressive and immotile sperm after sperm separation
Sperm concentration	Within 2 hours from the sperm collection	Assessment of sperm count after sperm separation
Sperm membrane potential	Within 2 hours from the sperm collection	Evaluation of the KCl-induced difference of membrane potential voltage in mV, after sperm selection.
Fertilization rates	17-20 hours after insemination by IVF or ICSI	Determination of the rate of 2 pronucleous, 2 polar bodies zygotes after insemination

Trial Locations

Locations (1)

CITMER; 🇲🇽 Mexico City, Mexico