A Novel Sperm Selection Method Provides Advantages Over Conventional Approaches
- Conditions
- Male Infertility
- 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
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Male
- Target Recruitment
- 115
- Normozoospermic (18-35 years old) and teratozoospermic (18-60 years old) patients undergoing IVF/ICSI cyles with at least 2 days of sexual abstinence
- Less than 4 oocytes collected during oocyte retrieval
- Total sperm count less than 30x10^6
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- 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
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (1)
CITMER
🇲🇽Mexico City, Mexico
CITMER🇲🇽Mexico City, Mexico