Comparative Evaluation of the Smart Phone-Based Self-Used Sperm Testing Device Versus Manual Semen Analysis in an Andrology Laboratory Setting
| Registry | NCT07880288 |
|---|---|
| Status | Active not recruiting |
| Phase | Not applicable |
| Study type | Interventional; na, single group, masking: none, diagnostic |
| Enrollment | 20 (Actual) |
| Sponsor | Armed Forces College of Medicine, Cairo, Egypt (Other); collaborators: Al-Azhar University, International Islamic Center for Population Studies and Research |
| Conditions | Semen Analysis, Male Infertility |
| Interventions | YO® Home Sperm Test, Manual Semen Analysis (WHO 6th Edition) (Device, diagnostic test) |
| Dates | start 2026-03-10, primary completion 2026-09-28, completion 2026-11-30 (estimated), first posted 2026-10-19, last updated 2026-10-19 |
| Locations | 1 site in Egypt |
Related Papers Related Patents Related Grants Related Experts
All trials for Semen Analysis All trials for Male Infertility All trials of YO® Home Sperm Test All trials of Manual Semen Analysis (WHO 6th Edition)
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.
| Arm | Type | Interventions | Description |
|---|---|---|---|
| YO® Home Sperm Test and Manual Semen Analysis | Experimental | Device: YO® Home Sperm Test; Diagnostic Test: Manual Semen Analysis (WHO 6th Edition) | 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. |
Sex: Male, ages: 18 Years to any, accepts healthy volunteers
Inclusion Criteria: * Adult males aged 18 years or older * Able and willing to produce a semen sample * Adherence to a sexual abstinence period of 3 to 5 days * Provision of written informed consent Exclusion Criteria: * Refusal or inability to give informed consent * Inability to produce a semen sample * Insufficient sample volume or quality for analysis * Known medical conditions affecting the sample that conflict with study goals * Any condition requiring urgent medical intervention
| Facility | City | Country | Status |
|---|---|---|---|
| Andrology Laboratory, Faculty of Medicine, Al-Azhar University | Cairo, Cairo Governorate | Egypt |