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Study for the impact of gut microbiota differences in patients with obese polycystic ovary syndrome to the curative effective differences of acupuncture between individuals

Study for the impact of gut microbiota differences in patients with obese polycystic ovary syndrome to the curative effective differences of acupuncture between individuals

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ITMCTR
Registry ID
ITMCTR2000003022
Enrollment
Unknown
Registered
2020-02-16
Start date
2020-03-01
Completion date
Unknown
Last updated
2023-02-20

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

Conditions

Polycystic ovary syndrome with obesity

Interventions

Sponsors

Chengdu University of Traditional Chinese Medicine
Lead Sponsor

Eligibility

Sex/Gender
Female

Inclusion criteria

Inclusion criteria: Inclusion criteria of PCOS 1. Infertile female with the reproductive needs, aged 20 to 40 years; 2. Diagnosed as having PCOS; 3. BMI>=25kg/m2; 4. Suitable for using clomiphene as ovulation induction treatment; 5. Sign the inform consent. Inclusion criteria of health participants: 1. Female, aged 20 to 40 years; 2. BMI<25kg/m2; 3. Regular menstruation; 4. Without primary dysmenorrhea in recent 1 year; 5. Normal blood/stool/urine test and SAS/SDS scales; 6. Sign the inform consent.

Exclusion criteria

Exclusion criteria: Exclusion criteria of PCOS: 1. Not diagnosed as PCOS; 2. Taking antibiotics history within 3 months; 3. Allergic constitution or allergic to various kinds of medicine; 4. Hyperandrogenism due to other reasons, including hyperprolactinemia, thyroid disease, congenital adrenal hyperplasia, Cushing syndrome, etc.; 5. Pathological endometrial changes, such as uterine malformation, hysteromyoma, etc., diagnosed by B ultrasound; 6. Genital tract malformation, gonadal dysgenesis, fallopian tube block, etc.; 7. Severe heart, liver, or renal dysfunction or hematological, respiratory, cardiovascular, psychiatric, or other metabolic disease; 8. Participation in other clinical trials at the same time; 9. Gastrointestinal surgery history; 10. Smoking history, alcohol history, inflammatory bowel disease, irritable bowel syndrome, autoimmune diseases, cancer and other disease that may influence the gut microbiota; 11. Taking probiotics with 1 month; 12. Suffering disease(s) causing inflammation without control; 13. Anxiety and depression; Note: 1 to 8 are suitable for clinical observation. 1 to 13 are suitable for gut microbiota analysis. Exclusion criteria of health participants: 1. Taking antibiotics history within 3 months; 2. Smoking history, alcohol history; 3. Diagnosed as psychosis, anxiety, depression, cognitive disorder, and allergic constitution. 4. Pregnant and breast-feeding woman; 5. Gastrointestinal surgery history; 6. Inflammatory bowel disease, irritable bowel syndrome, autoimmune diseases, cancer and other disease that may influence the gut microbiota; 7. Taking probiotics with 1 month; 8. Suffering disease(s) causing inflammation without control; 9. Participation in other clinical trials at the same time.

Design outcomes

Primary

MeasureTime frame
LH/FSH;

Secondary

MeasureTime frame
liver function and kidney function test;Six sex hormones analysis;Basal Body Temperature, BBT;FBG(fasting blood-glucose);inflammatory marks analysis;SAS anxiety scale;C- peptide release tests;urinary test;SDS depression scale;Intestinal flora analysis;Waist;blood routine examination;Leptin;Serum lipid level;Stool test;

Countries

China

Contacts

Public ContactJiao Chen

Chengdu University of Traditional Chinese Medicine

cjthz@126.com+86 18161170181

Outcome results

None listed

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