An interventional study of YO® Home Sperm Test and Manual Semen Analysis (WHO 6th Edition) in Semen Analysis and Male Infertility, sponsored by Armed Forces College of Medicine, Cairo, Egypt. Active, not recruiting at 1 site in Egypt. Open to male participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-10-19.
Sponsored by Armed Forces College of Medicine, Cairo, Egypt · Not applicable, Interventional, and Diagnostic
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Among 24 studies in Infertility, Male with a site in Egypt — 4 open to participants now, 7 under way, 2 of them phase 3. Infertility, Male · Egypt.
Among the 24 studies in Infertility, Male with a site in Egypt, this one is the 20th largest by enrollment of the 20 interventional ones that give a count, is one of 5 that started in 2026, is one of 12 with no phase, and was the 23rd registered.
282 studies on the registry are indexed under Infertility, Male; 65 are open to participants now.
Browse Infertility, Male studies →4 of the 24 studies in Infertility, Male with a site in Egypt are open now. Recruiting first, the newest first:
Beni-Suef University · Sites in Egypt
Ages 18–45 · Men only
Tanta University · Sites in Egypt
Ages 18–50 · Men only · Healthy volunteers
Fayoum University Hospital · Sites in Egypt
Ages 18–50 · Men only
Benha University · Sites in Egypt
Ages 18–50 · Men only
A study can be open while its sites in Egypt have not opened yet or have stopped. Only those recruiting at a site in Egypt →
Of the 40 Infertility, Male studies recruiting now, 16 (40%) set no upper age limit and 24 (60%) stop at 75 or younger; 7 take children under 18; 14 take healthy volunteers.
This study: 18 Years and older · male · healthy volunteers too.
The full table on the hub →This tab as a report to print or save as PDF → With an account.
24 studies; the count open now beside each. This study's row is marked.
A study in two phases is counted once above. Listed by phase, each with its combined phases: Phase 1 2 · Phase 2 2 · Phase 3 3 · Phase 4 3
First in 2012; this study’s year is marked. 5 started in 2026.
By drug class, each counting the studies that test any of its medicines:
This study's enrollment of 20 is below the median of 80 across 187 interventional studies indexed under Infertility, Male.
Median enrollment 131 across the 20 interventional studies, 80 across the 4 observational. Of the 15 that completed or were terminated, 0 (0%) have results posted.
This tab as a report to print or save as PDF → With an account.
None of the 24 has an industry lead sponsor. The 10 most frequent:
Armed Forces College of Medicine, Cairo, Egypt is the lead sponsor of 3 studies on the registry; none are open to participants now.
Armed Forces College of Medicine, Cairo, Egypt has 1 study filed under Infertility, Male — fewer than ten, so there is no comparison to draw.
2 of the studies in Infertility, Male with a site in Egypt that are under way reach primary completion within a year, 1 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT07915388Phase 3Fayoum University HospitalComparative Study of Post-Varicocelectomy Myo-inositol vs. Antioxidants vs. Surgery Alone in Infertile Men | 2027-06-29 |
| NCT07650955Beni-Suef UniversitySingle Infrapubic Versus Bilateral Subinguinal Microsurgical Varicocelectomy | 2027-04 |
Add all 2 to your calendar (.ics) → With an account.
Among the 24 studies in Infertility, Male with a site in Egypt, from their registry updates:
This tab as a report to print or save as PDF → With an account.
This study compares the YO® Home Sperm Test, a smartphone-based semen testing device, with conventional manual semen analysis performed according to the World Health Organization (WHO) 6th edition laboratory manual. Each participant provides one semen sample. A small aliquot is taken for testing with the YO® device, performed by the participant himself under supervision according to the manufacturer's instructions, and the remainder of the sample is analyzed manually in the andrology laboratory. The main question is how closely the motile sperm concentration (MSC) measured by the YO® device correlates with the MSC calculated from manual analysis. Secondary comparisons include sperm concentration, total motility, progressive motility and progressively motile sperm concentration. The study also compares the time needed to obtain results by each method and assesses participants' ease of use and satisfaction with the device. The aim is to determine whether this device could serve as a private, accessible screening tool for male fertility in Egypt.
Male factor contributes to about half of all infertility cases, yet in Egypt many men delay or avoid semen analysis because of social stigma and discomfort with providing samples in a clinical setting. The YO® Home Sperm Test uses a smartphone camera and a miniature optical attachment to record a video of the semen sample and calculate sperm concentration, total motility, progressive motility, motile sperm concentration (MSC) and progressively motile sperm concentration (PMSC), reporting the MSC result as "Low" or "Moderate/Normal" using a threshold of approximately 6 million motile sperm/mL. Published validation studies compared the device mainly with automated semen analyzers; data comparing it with manual microscopic analysis, the routine method in Egyptian andrology laboratories, are limited.
This prospective comparative cross-sectional study is conducted at the Andrology Laboratory, Faculty of Medicine, Al-Azhar University, Cairo, Egypt. Each participant provides a single semen sample collected by masturbation after 3 to 5 days of sexual abstinence into a sterile wide-mouthed container. After complete liquefaction, the sample is processed as follows:
YO® test: a small aliquot of the sample, in the volume specified by the manufacturer's instructions, is taken for testing with the YO® Home Sperm Test. Each participant receives a demonstration and explanation, then performs the test himself in a separate room within the same facility, with assistance and under supervision of trained medical personnel.
Manual analysis: the remainder of the sample is analyzed manually according to the WHO Laboratory Manual for the Examination and Processing of Human Semen (6th edition), including sperm concentration, total motility and progressive motility. MSC is calculated as: total sperm concentration × percentage of motile sperm / 100, and PMSC as: total sperm concentration × percentage of progressively motile sperm / 100.
The primary comparison is MSC between the two methods. Secondary comparisons include sperm concentration, total motility, progressive motility and PMSC. Results are compared for correlation, agreement and time to result. Participants also complete a short questionnaire on perceived ease of use and satisfaction with the device for potential home use.
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.
Exclusion Criteria:
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.
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.
Adult men attending the Andrology Laboratory, Faculty of Medicine, Al-Azhar University, who provide a single semen sample. A small aliquot of each sample is tested with the YO® Home Sperm Test, performed by the participant himself after demonstration and under supervision according to the manufacturer's instructions. The remainder of the sample is analyzed manually according to the WHO 6th edition manual as the reference standard. Participants then complete a short questionnaire on ease of use and satisfaction with the device.
Device: YO® Home Sperm Test · Diagnostic Test: Manual Semen Analysis (WHO 6th Edition)
FDA-cleared smartphone-based semen testing device that uses a miniature optical attachment and the smartphone camera to record a video of the semen sample and report sperm concentration, total motility, progressive motility, motile sperm concentration (MSC) and progressively motile sperm concentration. Performed by the participant after demonstration, under supervision of trained medical personnel.
Conventional microscopic semen analysis performed by trained laboratory personnel according to the WHO Laboratory Manual for the Examination and Processing of Human Semen (6th edition, 2021), including sperm concentration, total motility and progressive motility, with manual calculation of MSC and progressively motile sperm concentration.
Correlation Between YO® and Manual Motile Sperm Concentration (MSC)
Correlation coefficient and agreement (Bland-Altman mean bias and 95% limits of agreement) between motile sperm concentration (million/mL) measured by the YO® Home Sperm Test and MSC calculated from manual semen analysis according to the WHO 6th edition manual.
Time frame: Day 1 (single study visit, within 1 hour of semen sample collection)
Diagnostic Agreement Between YO® and Manual Analysis in Classifying Oligozoospermia and Asthenozoospermia
Sensitivity, specificity, positive and negative predictive values, overall accuracy and Cohen's kappa of the YO® Home Sperm Test in classifying samples as oligozoospermic (sperm concentration below 16 million/mL), asthenozoospermic (progressive motility below 30%) or oligoasthenozoospermic, using manual semen analysis according to the WHO 6th edition lower reference limits as the reference standard.
Time frame: Day 1 (single study visit, within 1 hour of semen sample collection)
Agreement in Sperm Concentration Between YO® and Manual Analysis
Correlation and agreement between sperm concentration (million/mL) measured by the YO® device and by manual semen analysis.
Time frame: Day 1 (single study visit, within 1 hour of semen sample collection)
Agreement in Total Motility Between YO® and Manual Analysis
Correlation and agreement between total sperm motility (%) measured by the YO® device and by manual semen analysis.
Time frame: Day 1 (single study visit, within 1 hour of semen sample collection)
Agreement in Progressive Motility Between YO® and Manual Analysis
Correlation and agreement between progressive sperm motility (%) measured by the YO® device and by manual semen analysis.
Time frame: Day 1 (single study visit, within 1 hour of semen sample collection)
Agreement in Progressively Motile Sperm Concentration (PMSC) Between YO® and Manual Analysis
Correlation and agreement between PMSC (million/mL) measured by the YO® device and PMSC calculated from manual semen analysis.
Time frame: Day 1 (single study visit, within 1 hour of semen sample collection)
Time to Result
Time in minutes from sample liquefaction to availability of the result, for the YO® device and for manual semen analysis.
Time frame: Day 1 (single study visit, within 1 hour of semen sample collection)
Participant Ease of Use and Satisfaction With the YO® Device
Participant-reported ease of use and satisfaction with the YO® Home Sperm Test for potential home use, assessed with a short questionnaire.
Time frame: Day 1 (single study visit, within 1 hour of semen sample collection)
Plan to share: No
Ran from Mar 2026 to primary completion in Sep 2026, 6 months.
Of 77 non-industry interventional studies with no phase under Infertility, Male, half reached primary completion within 28 months of starting (the median), counting those still running; a quarter within 17 and three quarters within 50. This study's 6 months is below that.
Counting every sponsor, half of 92 studies reached it within 34 months; a quarter within 17 and three quarters within 50.
How these figures are worked out, and which studies are left out of them.
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
This study is active, not recruiting, as verified in Oct 2026. You cannot join it, but the record below documents what was studied.
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Armed Forces College of Medicine, Cairo, Egypt