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Clinical trial of "Molecular Evaluation System for Human Sperm Quality"

Clinical trial of "Molecular Evaluation System for Human Sperm Quality"

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
ChiCTR
Registry ID
ChiCTR2500110533
Enrollment
Unknown
Registered
2025-10-15
Start date
2020-06-09
Completion date
Unknown
Last updated
2025-10-20

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

Conditions

Male infertility

Interventions

Gold Standard:Clinical Diagnosis of Male Fertility and Infertility
Index test:The fluorescence intensity and localization ratio data of 5 male infertility target molecules on sperm.

Sponsors

Peking University Third Hospital
Lead Sponsor

Eligibility

Sex/Gender
Male

Inclusion criteria

Inclusion criteria: Basic requirements: 1. Both men and women were 20-40 years old; 2. Abstinence for 2-7 days; No alcohol abuse within 2 weeks; Control group requirements: 1. The sample of natural conception requires that the wife has been pregnant for 3 months or more, or the child has been born within 2 months; 2. Sperm bank samples are required to have a storage number; 3.IVF samples were required to successfully obtain at least one fertilized egg. Case group requirements: 1. Have a history of infertility for more than one year; 2. Semen routine results met the requirements of "WHO Laboratory Manual for the examination and processing of Human semen" (2010 edition) on sperm number and motility; 3. In case group A, the women were required to obtain at least one fertilized egg after ICSI if the six tests were normal or IVF failed. 4.For cases B, C and D, the women were required to have normal six tests or to have successfully obtained at least one fertilized egg after ICSI.

Exclusion criteria

Exclusion criteria: Basic exclusion criteria: 1. Those who do not meet the inclusion criteria; 2. Patients with diseases that the clinical establishment (physician) considers inappropriate for participation in the trial. Control group: Samples conceived naturally with assisted reproductive technology were excluded. Case group: Patients with the following clear causes of male infertility were excluded: patients with small testes, patients with previous testicular trauma, patients with radiotherapy or chemotherapy after surgery for malignant tumors, patients with severe varicocele, patients with cryptorchidism, hematospermia, and leukocytospermia

Design outcomes

Primary

MeasureTime frame
Fluorescence intensity;

Secondary

MeasureTime frame
Localization rate;

Countries

China

Contacts

Public ContactHui Jiang

Peking University Third Hospital

vickyepi@outlook.com+86 131 8404 5612

Outcome results

None listed

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