Semen AnalysisNCT07880288
YO® Smartphone Home Sperm Test Versus Manual Semen Analysis in Egyptian Men
A study testing YO® Home Sperm Test and Manual Semen Analysis (WHO 6th Edition) in people with Semen Analysis and Male Infertility, run by Armed Forces College of Medicine, Cairo, Egypt at 1 site in Egypt.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older, men onlyHealthy volunteers can take part
- Conditions the study is for
- Semen Analysis, Male Infertility
- What is being tested?
- YO® Home Sperm Test and Manual Semen Analysis (WHO 6th Edition)
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteEgypt
- Study dates
- 10 Mar 2026to 30 Nov 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Men only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Egypt1 site
Andrology Laboratory, Faculty of Medicine, Al-Azhar University
Cairo, Cairo Governorate, 11884
About this study
Official title: Comparative Evaluation of the Smart Phone-Based Self-Used Sperm Testing Device Versus Manual Semen Analysis in an Andrology Laboratory Setting
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.
Read the detailed description
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.
- Conditions
- Semen Analysis, Male Infertility
- Being tested
- YO® Home Sperm Test, Manual Semen Analysis (WHO 6th Edition)
- Keywords
- Home Sperm Test, Smartphone-Based Semen Analysis, Motile Sperm Concentration, YO Sperm Test, Manual Semen Analysis, WHO 6th Edition, Sperm Motility
- Medical subject headings
- Infertility, Male
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
YO® Home Sperm TestDevice
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)Diagnostic test
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 group | Role | What they receive |
|---|---|---|
| YO® Home Sperm Test and Manual Semen Analysis | Experimental | 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. Receives: Device: YO® Home Sperm Test; Diagnostic Test: Manual Semen Analysis (WHO 6th Edition) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Day 1 (single study visit, within 1 hour of semen sample collection)
Secondary outcomes (7)
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Day 1 (single study visit, within 1 hour of semen sample collection)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Oct 2026
- Study start10 Mar 2026
- Primary completion28 Sep 2026
- Study completion30 Nov 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Semen AnalysisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Single-group diagnostic study. Each participant's semen sample is tested with both the YO® Home Sperm Test (index test) and manual semen analysis according to the WHO 6th edition manual (reference standard).
- Masking
- None (open label)
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Armed Forces College of Medicine, Cairo, Egypt
- Sponsor type
- University, hospital or other
- Collaborators
- Al-Azhar University, International Islamic Center for Population Studies and Research
- Responsible party
- Principal investigator, Ali Essam Ibrahim, Al-Azhar University
- Investigators
- Ahmad F Al-Sherbiny, MD, PhD, Study chair, International Islamic Center for Population Studies and Research, Al-Azhar UniversityAhmed Al-Shahed, MD, PhD, Study director, Al-Azhar University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07880288
- Sponsor's protocol ID
- (M.Sc.)236
- Status last verified
- Oct 2026
- First submitted
- 5 Oct 2026
- Last updated
- 19 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Bar-Chama N, Rabinovitch L, Honig S. Amateur vs Professional Users of the YO Home Sperm Test: An Assessment of Usability. Urology. 2024 Aug;190:162-169. doi: 10.1016/j.urology.2024.04.001. Epub 2024 May 3.
PubMed 38705243Agarwal A, Panner Selvam MK, Sharma R, Master K, Sharma A, Gupta S, Henkel R. Home sperm testing device versus laboratory sperm quality analyzer: comparison of motile sperm concentration. Fertil Steril. 2018 Dec;110(7):1277-1284. doi: 10.1016/j.fertnstert.2018.08.049. Epub 2018 Nov 10.
PubMed 30424879
Study at a glance
From the registry record, last updated by the sponsor on 19 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparative Evaluation of the Smart Phone-Based Self-Used Sperm Testing Device Versus Manual Semen Analysis in an Andrology Laboratory Setting
- ClinicalTrials.gov ID
- NCT07880288
- Acronym / sponsor ID
- (M.Sc.)236
- Conditions
- Semen Analysis, Male Infertility
- Keywords
- Home Sperm Test, Smartphone-Based Semen Analysis, Motile Sperm Concentration, YO Sperm Test, Manual Semen Analysis, WHO 6th Edition, Sperm Motility
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Armed Forces College of Medicine, Cairo, EgyptUniversity, hospital or other
- Collaborators
- Al-Azhar University, International Islamic Center for Population Studies and Research
- Study start
- 10 Mar 2026 (actual)
- Primary completion
- 28 Sep 2026 (actual)
- Study completion
- 30 Nov 2026 (estimated)
- First posted
- 19 Oct 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Single-group diagnostic study. Each participant's semen sample is tested with both the YO® Home Sperm Test (index test) and manual semen analysis according to the WHO 6th edition manual (reference standard).
| Arm | Type | Receives |
|---|---|---|
| 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| YO® Home Sperm TestFDA-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. | Device | YO® Home Sperm Test and Manual Semen Analysis |
| 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. | Diagnostic test | YO® Home Sperm Test and Manual Semen Analysis |
Primary outcome
Correlation Between YO® and Manual Motile Sperm Concentration (MSC)
Time frame: 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.
7 secondary outcomes
Diagnostic Agreement Between YO® and Manual Analysis in Classifying Oligozoospermia and Asthenozoospermia
Time frame: Day 1 (single study visit, within 1 hour of semen sample collection)
Agreement in Sperm Concentration Between YO® and Manual Analysis
Time frame: Day 1 (single study visit, within 1 hour of semen sample collection)
Agreement in Total Motility Between YO® and Manual Analysis
Time frame: Day 1 (single study visit, within 1 hour of semen sample collection)
Agreement in Progressive Motility Between YO® and Manual 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
Time frame: Day 1 (single study visit, within 1 hour of semen sample collection)
Time to Result
Time frame: Day 1 (single study visit, within 1 hour of semen sample collection)
Participant Ease of Use and Satisfaction With the YO® Device
Time frame: Day 1 (single study visit, within 1 hour of semen sample collection)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Oct 2026.
- Results publication: PubMed 38705243Bar-Chama N, Rabinovitch L, Honig S. Amateur vs Professional Users of the YO Home Sperm Test: An Assessment of Usability. Urology. 2024 Aug;190:162-169. doi: 10.1016/j.urology.2024.04.001. Epub 2024 May 3.
- Results publication: PubMed 30424879Agarwal A, Panner Selvam MK, Sharma R, Master K, Sharma A, Gupta S, Henkel R. Home sperm testing device versus laboratory sperm quality analyzer: comparison of motile sperm concentration. Fertil Steril. 2018 Dec;110(7):1277-1284. doi: 10.1016/j.fertnstert.2018.08.049. Epub 2018 Nov 10.
- Individual participant dataSharing planned: No
Related trials for Semen Analysis
Not yet recruitingObservational study
Internal Spermatic Vein Histopathology in Patients Undergoing Varicocelectomy
Varicocele
RecruitingObservational study
Human Sperm Cryopreservation as an Alternative to the Decline of Sperm Quality With Aging
Aging, Epigenetic Aging
Not yet recruiting
Effect of Varicocelectomy on Spermatogenic Cell Count and Semen Parameters
Varicocele, Male Infertility
Not yet recruiting
Selective Extended Venous Stripping Versus Standard Microsurgical Varicocelectomy for Varicocele-Related Male Infertility
Varicocele, Male Infertility
RecruitingObservational study
Measuring Free Radicals in Human Sperm Cells Related to Microbiota and Lifestyle Factors
Infertility, Male, Infertility
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ahmad F Al-Sherbiny, MD, PhD study chair
International Islamic Center for Population Studies and Research, Al-Azhar University
Ahmed Al-Shahed, MD, PhD study director
Al-Azhar University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing YO® Home Sperm Test and Manual Semen Analysis (WHO 6th Edition) in people with Semen Analysis and Male Infertility, run by Armed Forces College of Medicine, Cairo, Egypt at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 19 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Correlation Between YO® and Manual Motile Sperm Concentration (MSC) (time frame: Day 1 (single study visit, within 1 hour of semen sample collection)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07880288, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Oct 2026.