Skip to content

Clinical trial of inhibin A kit

Inhibin A Assay Kit (Magnetic Particle Chemiluminescence Method) Clinical Trial

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
ChiCTR
Registry ID
ChiCTR2500114737
Enrollment
Unknown
Registered
2025-12-17
Start date
2025-02-28
Completion date
Unknown
Last updated
2026-01-05

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

Conditions

Polycystic ovary syndrome, gonadal dysfunction, etc.

Interventions

Gold Standard:Beckman Coulter, Inc. (USA) produced the Inhibin A assay kit (chemiluminescence method) Access INHIBIN A, used as a comparative reagent.
Index test:Inhibin A Assay Kit (Magnetic Microparticle Chemiluminescence) developed by Shenzhen New Industries Biomedical Engineering Co., Ltd.

Sponsors

Sichuan Provincial People's Hospital
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: 1. Patients with suspected reproductive hormone disorders: (1) Women have clinical manifestations such as hirsutism, infertility, amenorrhea, menopause, and irregular menstruation;(2) Clinical manifestations such as infertility and early development of secondary sexual characteristics in men. You must meet any of the requirements of (1) and (2) to be selected. 2.Patients with reproductive hormone disorders: (1) Women with polycystic ovary syndrome, premature ovarian failure and decreased ovarian reserve;(2) Men with testicular dysfunction and other phenomena;(3) Those with abnormal laboratory reproductive hormone examination. Applicants must meet the requirements of (1) (3) or (2) (3) to be selected. 3. Confusing cases: abnormal thyroid function, etc. 4.Samples containing interfering substances such as lipidemia, hemolysis, jaundice, etc., or samples containing cross-substance such as luteinizing hormone and thyroid-stimulating hormone.

Exclusion criteria

Exclusion criteria: 1.The clinical information of the subject's sample is incomplete and cannot be traced. 2. The subject's sample does not meet the requirements for sample collection and preservation. 3. The subject's sample is suspected to be turbid due to microbial contamination. 4. Duplicate enrollment of the subject's sample. 5. The sample size of the subject is not enough to meet the testing requirements of the assessment reagent and the comparison reagent. 6. Other reasons that the investigator considers unsuitable for enrollment.

Design outcomes

Primary

MeasureTime frame
Compare the results of reagent tests;Evaluate the test results of reagents;

Countries

China

Contacts

Public ContactHuang Yi

Sichuan Provincial People's Hospital

Hwuangyi@qq.com+86 17744339858

Outcome results

None listed

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