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Evaluation of diagnostic methods for female patients with hyperandrogenism and investigation the roles and characteristics of gut microbiota

Evaluation of diagnostic methods for female patients with hyperandrogenism and investigation the roles and characteristics of gut microbiota

Status
Active, not recruiting
Phases
Early Phase 1
Study type
Observational
Source
ChiCTR
Registry ID
ChiCTR2000041108
Enrollment
Unknown
Registered
2020-12-18
Start date
2018-05-20
Completion date
Unknown
Last updated
2021-03-01

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

Conditions

Female patients with hyperandrogenism (PCOS)

Interventions

PCOS:Non
Healthy Volunteers :Non

Sponsors

The First Affiliated Hospital of Shantou University Medical College
Lead Sponsor

Eligibility

Sex/Gender
Female
Age
16 Years to 37 Years

Inclusion criteria

Inclusion criteria: 1. In this study, PCOS patients represent female hyperandrogenemia 2. According to Rotterdam standards, the following criteria are met: (1) Hypomenorrhea or anovulation; (2) Clinical manifestations of hyperandrogenemia or biochemical evidence of hyperandrogenemia; (3) Ovarian ultrasound showed that the number of cysts with diameter of 2-9mm on each side was greater than or equal to 12 or the volume of ovary was greater than or equal to 10ml, which met more than 2 criteria, and excluded CAH, Cushing syndrome, hyperprolactinemia and thyroid dysfunction.

Exclusion criteria

Exclusion criteria: 1. Patients with diabetes, hypertension, connective tissue disease and other chronic diseases who need long-term medication; 2. Patients with endocrine diseases such as thyroid, adrenal and gonadal diseases who need long-term medication; 3. Patients with intestinal diseases, such as inflammatory bowel disease, or patients undergoing intestinal surgery; 4. Patients with severe liver, kidney and heart dysfunction; 5. Patients using antibiotics in recent 1 month.

Design outcomes

Primary

MeasureTime frame
Gut microbiota;Serum androgen (TT, AD, DHEA and DHS) concentration;FKBP5 DNA methylation;Plasma non targeted metabolome;

Countries

China

Contacts

Public ContactYin Guoshu

The First Affiliated Hospital of Shantou University Medical College

yinguoshu@126.com+86 13417029106

Outcome results

None listed

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