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Evaluation of Semen DNA Integrity Based on Cascade Cas12a Amplification Strategy

Evaluation of Semen DNA Integrity Based on Cascade Cas12a Amplification Strategy

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
ChiCTR
Registry ID
ChiCTR2500095611
Enrollment
Unknown
Registered
2025-01-09
Start date
2024-09-12
Completion date
Unknown
Last updated
2025-01-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Sperm quality is substandard

Interventions

Gold Standard:Sperm DNA Fragmentation Index
Index test:The average number of sperm DNA breakpoints

Sponsors

Southern Medical University Southern Hospital
Lead Sponsor

Eligibility

Sex/Gender
Male
Age
18 Years to No maximum

Inclusion criteria

Inclusion criteria: Inclusion Criteria for Patients with Unqualified Sperm Quality: 1. Age>=18, male only; 2. Voluntarily sign the informed consent form; 3. Patients diagnosed with unqualified sperm quality by the World Health Organization Manual of Human Semen Laboratory Testing (Fifth Edition); 4. Not receiving any treatment; 5. No mental illness, can understand and communicate normally. Inclusion Criteria for Qualified Patients with Sperm Quality: 1. Age>=18, male only; 2. Voluntarily sign the informed consent form; 3. Patients diagnosed with qualified sperm quality by the World Health Organization Manual of Human Semen Laboratory Testing (Fifth Edition); 4. Normal individuals diagnosed with no underlying diseases and tumors in Nanfang Hospital, i.e., normal liver function, normal electrocardiogram, normal tumor markers and routine blood tests.

Exclusion criteria

Exclusion criteria: Exclusion Criteria for Patients with Unqualified Sperm Quality: 1. Disease; 2. Severe organ dysfunction; 3. Female; 4. Cases in which the subject's information is incomplete, or the collection is incomplete for other reasons; 5. It is judged by the investigator to be unsuitable to participate in this study. Sperm Quality Eligible Patients Exclusion Criteria: 1. Female; 2. Cases with incomplete subject information or incomplete collection for other reasons; 3. It is judged by the investigator to be unsuitable to participate in this study.

Design outcomes

Primary

MeasureTime frame
The average number of sperm DNA breakpoints;

Countries

China

Contacts

Public ContactYe Zhang

Nanfang Hospital, Southern Medical University

Zhangye232@i.smu.edu.cn+86 15622126037

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026