Screening of immune markers of phlegm-dampness type PCOS based on single cell transcriptome sequencing and study on the intervention of traditional Chinese medicine for reducing phlegm-dampness

Phase 1

Recruiting

• Conditions: polycystic ovarian syndrome

• Registration Number: ITMCTR2100004800
• Lead Sponsor: Shandong 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: Recruiting
• Sex: Female
• Target Recruitment: Not specified

Inclusion Criteria

Phlegm-dampness PCOS infertile subjects
1. Diagnostic criteria for polycystic ovary syndrome: according to the Guidelines for the Diagnosis and Treatment of Polycystic ovary syndrome in China formulated by the Endocrinology Group of the Chinese Society of Obstetrics and Gynecology in 2018:
(1) Periphery menstruation or amenorrhea or irregular uterine bleeding;
(2) Clinical manifestations of hyperandrogen or hyperandrogenemia;
(3) The ultrasonography showed polycystic ovary like morphology.
The above mentioned conditions are (1), in line with one of (2)(3), and exclude diseases that may cause hyperandrogen, such as Cushing's syndrome, atypical congenital adrenal hyperplasia, androgen-secreting tumors of ovary or adrenal gland, and diseases that may cause abnormal ovulation, such as functional hypothalamic amenorrhea.
2. Traditional Chinese medicine dialectical standards for phlegm and dampness syndrome: formulated with reference to the Traditional Chinese Medicine Industry Standards of the People's Republic of China -- Standards for Diagnosis and Efficacy of Diseases of Traditional Chinese Medicine and the seventh edition of the national textbook Traditional Chinese Gynecology. At least three experts with senior title of TCM gynecology conducted independent dialectical analysis on the selected patients, and the conclusion conforming ones could be included.
Main signs:
(1) Long marriage infertility;
(2) Menstrual period, or gradually to amenorrhea;
(3) Less menstrual volume, light red color.
Concurrent disease:
(1) Body obesity;
(2) Chest tightness nausea;
(3) With the amount of sticky;
(4) Loose stools or diarrhea through diarrhea. Tongue pulse: the tongue is pale and greasy with white moss, and the pulse is slippery and weak.
The above three main syndromes are necessary. With 1-2 concurrent syndromes, the diagnosis can be made. Tongue pulse is the reference.
3. Meet the diagnostic criteria of polycystic ovary syndrome and TCM syndrome differentiation criteria of phlegm and dampness syndrome, and have the following items:
(1) Aged < 40 years;
(2) Cohabitation after marriage for more than one year, normal sexual life, no contraception and no pregnancy;
(3) Outine semen examination of the man was generally normal.

Exclusion Criteria

1. Reproductive system malformation or serious systemic diseases can not bear pregnancy;
2. Severe mental illness, or sexually transmitted diseases, or chromosomal abnormalities resulting in infertility;
3. Acute reproductive system disease infection stage, or exposure to teratogenic radiation, poison, and in the action stage;
4. Infertility caused by endometriosis, hyperprolactinemia and other diseases;
5. Do not take drugs according to the regulations or have poor compliance.

Study & Design

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

Primary Outcome Measures

Name	Time	Method
Follicular stimulating hormone;Antral follicle count;Subsets of immune cells;Luteinizing hormone;

Secondary Outcome Measures

Name	Time	Method
estradiol;progesterone;