Status:
NOT_YET_RECRUITING
Functional Development and Clinical Validation of a Diagnostic Tool Based on Artificial Intelligence for the Assessment of Sperm Quality and the Selection of the Optimal In Vitro Fertilisation (IVF) Treatment
Lead Sponsor:
Instituto Valenciano de Infertilidad, IVI VALENCIA
Conditions:
Infertility (IVF Patients)
Male Fertility
Eligibility:
MALE
18-50 years
Brief Summary
Infertility is a growing global health problem affecting millions of couples worldwide, with male infertility accounting for approximately half of all cases. In the physiological environment, sperm go...
Eligibility Criteria
Inclusion
- Inclusion criteria:
- Men between the ages of 18 and 50 who come to the clinic to undergo an ICSI cycle.
- Men between the ages of 18 and 50 who come to the clinic to undergo an artificial insemination cycle.
- All embryos will be placed in a time-lapse incubator.
- All women over 18 years of age who have obtained a MII number greater than or equal to 2 in oocyte retrieval, without excluding couples from the oocyte donation programme.
- All men and women with a previously known normal karyotype.
- Informed consent (IC) provided and signed by patients.
- Exclusion criteria:
- All women diagnosed with recurrent pregnancy loss.
- All semen samples obtained by testicular biopsy.
- All donor semen samples.
Exclusion
Key Trial Info
Start Date :
November 1 2025
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
November 1 2027
Estimated Enrollment :
200 Patients enrolled
Trial Details
Trial ID
NCT07185984
Start Date
November 1 2025
End Date
November 1 2027
Last Update
September 22 2025
Active Locations (1)
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1
IVI Valencia
Valencia, Spain, 46015