Status:
NOT_YET_RECRUITING
Use of the SiDTM v2.0 Algorithm to Assist Embiyologists in Sperm Selection During ICSI Procedures
Lead Sponsor:
Instituto Valenciano de Infertilidad, IVI VALENCIA
Collaborating Sponsors:
IVF 2.0 Limited
Conditions:
Male Fertility
Testicular
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
Infertility is defined as a failure of a couple to achieve a pregnancy after 12 or more months of unprotected intercourse. Males are found to be solely responsible for 20-30% of infertility cases but ...
Eligibility Criteria
Inclusion
- Patients with indication for ICSI.
- Women of advanced maternal age (\>35 years) in whom at least 4 oocytes in metaphase II stages are obtained in the follicular puncture, without excluding patients from the oocyte donation program.
- Sperm obtained by masturbation with a concentration above 1 million spermatozoa/mL after sperm capacitation.
- Normal karyotype of both partners.
- Informed Consent (IC).
Exclusion
- Patients diagnosed with recurrent gestational loss.
- Semen extracted by testicular biopsy.
- Semen samples with globozoospermia (sperm defect due to lack of acrosome) or azoospermia (absence of spermatozoa in the ejaculate).
- Semen samples treated with pentoxifylline.
- ICSI cycles with application of calcium ionophore. o ICSI cycles with application of calcium ionophore.
Key Trial Info
Start Date :
October 1 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
October 1 2027
Estimated Enrollment :
100 Patients enrolled
Trial Details
Trial ID
NCT07163754
Start Date
October 1 2025
End Date
October 1 2027
Last Update
September 9 2025
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