Male Infertility
Conditions
Keywords
Spem preparation, in vitro fertilization, Sperm membrane potential, Sperm intracellular calcium
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
Interventions
Sperm separation with density gradients
DEVICECA0 chamber
Sperm separation with a novel device
Sponsors
Universidad Nacional Autonoma de Mexico
Center of Innovation Technology & Reproductive Medicine
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
SINGLE (Subject)
Masking description
Participants did not know if their sperm would be selected by density gradient centrifugation ir the novel device (CA0 chamber)
Eligibility
Sex/Gender
MALE
Age
18 Years to 35 Years
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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. |
| Sperm intracellular Calcium | Within 2 hours from the sperm collection | Evaluation of the progesterone-induced intracellular calcium fluorescent peaks after sperm selection |
| Sperm concentration | Within 2 hours from the sperm collection | Assessment of sperm count after sperm separation |
| Sperm motility | Within 2 hours from the sperm collection | Percentage of progresive, non-progressive and immotile sperm after sperm separation |
| Fertilization rates | 17-20 hours after insemination by IVF or ICSI | Determination of the rate of 2 pronucleous, 2 polar bodies zygotes after insemination |
Countries
Mexico
Outcome results
None listed