Oligospermia?Asthenospermia
Conditions
Interventions
Gold Standard:Fully automatic analysis of commercially available sperm analysis equipment
Index test:Portable Sperm Quality Analyzers Using CNN
Sponsors
Shanghai General Hospital
Eligibility
Sex/Gender
Male
Age
18 Years to 55 Years
Inclusion criteria
Inclusion criteria: 1. Semen samples are sourced from adult male patients (age >= 18 years) visiting the Andrology Laboratory of Shanghai First People's Hospital, and the sample collection complies with standard clinical operational protocols. 2. Semen samples have undergone clinical testing (such as routine sperm quality analysis) and have been determined by clinical physicians to have no further clinical use and can be discarded. 3. The volume of semen samples is >=0.5 mL, sufficient to meet the requirements for capturing images of the same semen sample with a "medical magnifying glass" and commercially available sperm analysis devices (at least 6 clear images per device). 4. Image acquisition is completed within 2 hours after semen sample collection, and the samples show no incomplete liquefaction (liquefaction time exceeding 60 minutes) or contamination (such as mixed with blood, urine, bacterial growth, etc.) that would affect image quality and analysis results. 5. The personal information of patients corresponding to semen samples can be completely anonymized, with identifying information such as name, medical record number, and test time removed to prevent disclosure of patient identity.
Exclusion criteria
Exclusion criteria: 1. Semen samples have not completed clinical testing, or although testing has been completed, they still have subsequent clinical use value (such as for research related to assisted reproductive technology) and have not been deemed disposable; 2. Semen sample volume < 0.5 mL, unable to meet the requirement for simultaneous image acquisition by two devices, or sample loss during acquisition causes some devices to fail to obtain valid images; 3. Semen samples have issues such as incomplete liquefaction, contamination, or too low sperm concentration, and even after preprocessing, still cannot meet the requirements for clear image acquisition and sperm target recognition; 4. The storage time after semen sample image acquisition exceeds 2 hours, or storage conditions do not meet standards (such as temperature deviating from the 20-37°C range), which may cause changes in sperm motility and morphology, affecting the accuracy of model training and validation.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Sperm motility;Accuracy; | — |
Secondary
| Measure | Time frame |
|---|---|
| Sperm motility trajectory;Sensitivity;Specificity; | — |
Countries
China
Contacts
Public ContactZhi Erlei
Shanghai General Hospital
Outcome results
None listed