An observational study in Infertility (IVF Patients), Male Fertility and Sperm Selection, sponsored by Instituto Valenciano de Infertilidad, IVI VALENCIA. Not yet recruiting at 1 site in Spain. Open to male participants aged 18 Years to 50 Years. Per ClinicalTrials.gov, last updated 2025-09-22.
Sponsored by Instituto Valenciano de Infertilidad, IVI VALENCIA · Observational
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 through an exhaustive selection process in the female reproductive tract before reaching the oocyte. During this journey, progressive mobility and morphology are key parameters for achieving fertilisation. Therefore, before starting an assisted reproduction treatment, it is essential to analyse and process the semen sample to assess the fertile potential, select the most optimal sperm and determine the most appropriate treatment.
Conventional methods of semen processing, such as density gradient centrifugation (DGC) and Swim-up washing of motile sperm, have significant limitations. These include interobserver and interlaboratory subjectivity, as well as damage to sperm DNA caused by centrifugation. Alternatively, microfluidics, which simulates natural selection, allows higher counts of morphologically normal, progressive motile sperm to be obtained. On the other hand, the CASA (computer-assisted sperm analysis) system has improved the standardisation and quality of semen analysis. Furthermore, the incorporation of Artificial Intelligence (AI) into semen quality analysis represents a promising opportunity, as it improves efficiency, accuracy and standardisation, and has the potential to increase success rates in assisted reproduction treatments.
This project aims to develop an innovative AI-based diagnostic tool to address male infertility. The tool will integrate microfluidic technology and the CASA system to analyse semen quality, calculate fertilisation potential and recommend personalised treatments with an estimate of success. Trained with large volumes of biological and clinical data, it will provide a comprehensive and patient-specific diagnosis by identifying complex relationships between multiple variables. Finally, a comparative study will be conducted to evaluate laboratory indicators and clinical outcomes of cycles using this tool versus those using conventional methods.
2,085 studies on the registry are indexed under Infertility; 357 are open to participants now.
This study's planned enrollment of 200 is close to the median of 200 across 592 observational studies indexed under Infertility.
Browse Infertility studies →Instituto Valenciano de Infertilidad, IVI VALENCIA is the lead sponsor of 72 studies on the registry; 8 are open to participants now.
Counted across the registry records on this site, refreshed daily.
The study population will include patients who attend the IVIRMA Valencia clinic for a cycle of artificial insemination or a cycle of ICSI and undergo sperm selection using the Harvester microfluidic technique.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Men between the ages of 18 and 50 who come to the clinic to undergo an ICSI cycle.
All women diagnosed with recurrent pregnancy loss.
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
A biopsy takes a small piece of tissue to examine. “Archival tissue” is a sample already taken, for example at diagnosis, and kept by the hospital.
Whether a stored sample will do depends on when it was taken, how much there is and what the study needs. Ask whether the study accepts your stored sample or needs a new biopsy.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Biopsy and archival tissue
A biopsy takes a small piece of tissue to examine. “Archival tissue” is a sample already taken, for example at diagnosis, and kept by the hospital.
Whether a stored sample will do depends on when it was taken, how much there is and what the study needs. Ask whether the study accepts your stored sample or needs a new biopsy.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Small aliquots of 100 fresh human semen samples will be analysed using the SwimCount™ Harvester system. The sperm variables analyzed will include concentration, motility (total and progressive), morphology, movement speed, and trajectory.
Diagnostic Test: Sperm sellection
100 additional fresh semen samples processed with the integrated microfluidics system (SwimCount™ Harvester) and the CASA system with artificial intelligence
Diagnostic Test: DIAGNOSIS TOOL
Small aliquots of 100 fresh human semen samples will be analysed using the SwimCount™ Harvester system, a CE-marked microfluidic technology patented by MCount and designed for routine clinical use.
The diagnostic tool developed will be validated by analyzing small aliquots of 100 additional fresh semen samples processed with the integrated microfluidic system (SwimCount™ Harvester) and the CASA system with artificial intelligence. To evaluate the diagnostic efficiency of the tool, the results obtained from the semen quality analysis will be compared with those obtained from the analysis of these samples when processed using the reference technique, based on conventional methods employed by fertility specialists. Finally, to determine the effectiveness of the developed tool, the clinical results obtained from assisted reproduction treatment will be compared with the diagnosis predicted by the tool, with the aim of evaluating its predictive capacity. Translated with DeepL.com (free version)
Development of a Male Infertility Diagnosis Tool
Tool development
Time frame: 2 YEARS
Prediction Capability Identification
Measure of correlation between clinical data and tool prediction
Time frame: 2 Years
Development of an AI algorithm
Development of an AI algorithm
Time frame: 2 years
Plan to share: No
Start is estimated for Nov 2025; primary completion for Nov 2027, 24 months later.
Of 209 non-industry observational studies under Infertility, half reached primary completion within 39 months of starting (the median), counting those still running; a quarter within 15 and three quarters within 100. This study's planned 24 months is below that.
Counting every sponsor, half of 242 studies reached it within 39 months; a quarter within 16 and three quarters within 100.
How these figures are worked out, and which studies are left out of them.
This study is not yet recruiting, as verified in Sep 2025. You cannot join it, but the record below documents what was studied.
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Instituto Valenciano de Infertilidad, IVI VALENCIA