A Novel Sperm Selection Method Provides Advantages Over Conventional Approaches

Center of Innovation Technology & Reproductive Medicine

Status: Completed

Conditions: Male Infertility

Treatments: Device: CA0 chamber; Device: Density Gradient Centrifugation

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT06545318

CI-21-101

Details and patient eligibility

About

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

Enrollment: 115 patients

Sex: Male

Ages: 18 to 35 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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115 participants in 2 patient groups

Density Gradient Centrifugation

Active Comparator group

Description:

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

Treatment:

Device: Density Gradient Centrifugation

CA0 chamber

Experimental group

Description:

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

Treatment:

Device: CA0 chamber