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Clinical Trials in Egypt / NCT07880288
Active, not recruiting Not applicable

YO® Smartphone Home Sperm Test Versus Manual Semen Analysis in Egyptian Men

NCT07880288 · tracked via the Priya Life Science Egypt tracker
Sponsor
Armed Forces College of Medicine, Cairo, Egypt
Phase
Not applicable
Started
2026-03-10
Last updated
2026-10-19

Condition(s) studied

Semen AnalysisMale Infertility

Investigational drug(s) / intervention(s)

YO® Home Sperm TestManual Semen Analysis (WHO 6th Edition)

YO® Home Sperm Test: 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.

Manual Semen Analysis (WHO 6th Edition): 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.

Study summary

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.

Eligibility

Sex
MALE
Min age
18 Years
Max age
—
Healthy volunteers
Accepted
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

Primary outcome measure(s)

  • Correlation Between YO® and Manual Motile Sperm Concentration (MSC) — Day 1 (single study visit, within 1 hour of semen sample collection)
    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.

Trial sites (1)

FacilityCityRegionStatus
Andrology Laboratory, Faculty of Medicine, Al-Azhar University Cairo Cairo Governorate

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Selective Extended Venous Stripping Versus Standard Microsurgical Varicocelectomy for Varicocele-Related Male Infertility Starting soon
Impact of tdrd9 Gene Mutations in the Therapeutic Response to L-carnitine in Oligoasthenozoospermic Men Active, not recruiting
Trial to Improve Fertilization Rate and Embryo Development in Intracytoplasmic Sperm Injection (ICSI) Cycles Active, not recruiting
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07880288 on ClinicalTrials.gov ↗ ← All trials in Egypt