Correlation of Ovulation Disorder Infertility of Polycystic Ovary Syndrome and Psychological Stress and Study on the Intervention of Bushen Jieyu Tiaochong Formula

Phase 1

• Conditions: Polycystic Ovary Syndrome

• Registration Number: ITMCTR2100004724
• Lead Sponsor: Dongzhimen Hospital, Beijing 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

(1) They are 20-40 years old and have fertility requirements;
(2) Syndrome differentiation of kidney depression and ovulation syndrome of Western medicine accord with PCOS standard of the patients;
(3) No ovulation induction drugs including clomiphene citrate were taken within 3 months;
(4) After salpingography, the uterus was normal and at least one side of the fallopian tube was unobstructed;
(5) Those who can accept follow-up and color Doppler ultrasound examination after treatment;
(6) Those who voluntarily receive drug treatment, can return visit on time, and can observe clinical treatment as required;
(7) There was no history of serious drug allergy;
(8) Willing to cooperate with clinical trials and sign informed consent.

Exclusion Criteria

(1) There are other infertility factors: premature ovarian failure, uterine factors, such as gonadal hypoplasia, reproductive tract malformation, organic diseases of reproductive organs (adenomyosis, hysteromyoma, etc.), pelvic inflammatory diseases; hysterosalpingostomy; the factors of immunity and male side were immune factors and male factors;
(2) Other diseases with similar clinical and endocrine signs as PCOS, such as thyroid dysfunction, hyperprolactinemia, congenital adrenal hyperplasia, androgen secreting tumor, Cushing's syndrome, etc;
(3) All kinds of malignant tumors, combined with serious cardiovascular and cerebrovascular diseases, liver, kidney, hematopoietic system diseases and mental illness;
(4) Patients with previous history of clomiphene citrate resistance;
(5) They have been exposed to teratogenic radiation, poison or drugs and are in the active stage;
(6) Patients with incomplete clinical data are difficult to diagnose;
(7) Those who fail to comply with the regulations and are not able to follow up regularly;
(8) Those who participated in other clinical studies and influenced the results of this study.

Study & Design

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

Primary Outcome Measures

Name	Time	Method
Clinical pregnancy rate;

Secondary Outcome Measures

Name	Time	Method
Cycle ovulation rate;Six female sex hormones;Serum monoamine neurotransmitter concentration;OHSS, LUFS cycle incidence;