Clinical trial NCT06545318: A Novel Sperm Selection Method Provides Advantages Over Conventional Approaches
Official title: A Novel Sperm Selection Method Provides Advantages Over Conventional Approaches: Validation Through a Clinical Pilot Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Male Infertility
Keywords: Spem preparation
in vitro fertilization
Sperm membrane potential
Sperm intracellular calcium
Lead sponsor: Center of Innovation Technology & Reproductive Medicine
Sponsor class: INDUSTRY
Collaborators: name: Universidad Nacional Autonoma de Mexico
First posted: 2024-08-09
Enrollment: 115
Sex: MALE
Minimum age (years): 18
Maximum age (years): 35
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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


Eligibility criteria: 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

Primary outcomes:
measure: Sperm membrane potential
timeFrame: Within 2 hours from the sperm collection
measure: Sperm intracellular Calcium
timeFrame: Within 2 hours from the sperm collection
measure: Sperm concentration
timeFrame: Within 2 hours from the sperm collection
measure: Sperm motility
timeFrame: Within 2 hours from the sperm collection
measure: Fertilization rates
timeFrame: 17-20 hours after insemination by IVF or ICSI
Secondary outcomes:
Other outcomes:
Locations:
city: Mexico City
country: Mexico
facility: CITMER
Study officials:
affiliation: Departamento de Genética del Desarrollo y Fisiología Molecular, Instituto de Biotecnología (IBT), Universidad Nacional Autónoma de México (UNAM), Cuernavaca, Morelos, México
name: Claudia L Treviño
role: PRINCIPAL_INVESTIGATOR
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