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

Not Applicable

• Conditions: Polycystic ovary syndrome with obesity

• Registration Number: ITMCTR2000003022
• Lead Sponsor: Chengdu University of Traditional Chinese Medicine

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Last Update Posted: 20 February 2023

Recruitment & Eligibility

• Status: Pending
• Sex: Female
• Target Recruitment: Not specified

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 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.

Study & Design

• Study Type: Interventional study
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
H/FSH;

Secondary Outcome Measures

Name	Time	Method
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;