A double-blind, randomized, dose-finding trial of He's Yangchao Granules in the treatment of infertile female with decreased ovarian reserve

Not Applicable

• Conditions: Infertility patients with diminished ovarian reserve

• Registration Number: ITMCTR2200005760
• Lead Sponsor: Hangzhou Hospital of Traditional Chinese Medicine Affiliated to Zhejiang Chinese Medical University

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.Female infertility patients (including patients with primary or secondary infertility) who are aged 25 to 45 years and will attend the gynecology clinic of our hospital; 2.Diagnosis in line with DOR (refer to Obstetrics and Gynecology (9th edition), Reproductive Endocrinology (2nd edition), and combined with clinical, is formulated as follows): (1)Basic Follicle Stimulating Hormone (FSH): 10 -40IU/L, or Follicle Stimulating Hormone (FSH)/Luteinizing Hormone (LH)>3); (2) The number of antral follicles (AFC) determined by vaginal ultrasound is less than 5; (3) AMH 0.5-1.1ng/ml (4) Clinical symptoms: Menstrual cycle exists, but menstrual period, menstrual volume, color quality change; waist and knee soreness, hot flashes and night sweats, insomnia and dreaminess, dizziness, tinnitus, irritability, palpitations, fatigue and other symptoms. If it meets (1),(2),(3),(4),it can be diagnosed. 3.Approved by the hospital ethics committee, all patients gave informed consent.

Exclusion Criteria

1.Patients have participated in other clinical trials within 3 months; 2.Exclude uncontrollable and/diagnosed medical conditions that may interfere with or affect the research and treatment, such as severe liver, kidney, heart and brain diseases; uncontrolled hypertension, diabetes; 3.Taking drugs that affect hormone metabolism in the past 3 months, such as contraceptives, glucocorticoids, estrogen, thyroid hormone, calcitonin, bisphosphonates, vitamin D, calcium-containing drugs, barbiturates, traditional Chinese medicine, Chinese patent medicine, etc.; 4.Patients with chromosomal abnormalities in peripheral blood; 5.Patients with mental illness who cannot cooperate; 6.No bad habits such as smoking and alcohol abuse.

Study & Design

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

Primary Outcome Measures

Name	Time	Method
Serum levels of estradiol, testosterone, luteinizing hormone, follicle stimulating hormone and anti-Muller hormone;Antral follicle count;

Secondary Outcome Measures

Name	Time	Method
Clinical pregnancy rate;Live birth rate;Pregnancy complications, miscarriage rate;