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

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

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ITMCTR
Registry ID
ITMCTR2200005760
Enrollment
Unknown
Registered
2022-03-24
Start date
2022-04-01
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

Infertility patients with diminished ovarian reserve

Interventions

group B:He's Yangchao Granules(low dose)
group A:He's Yangchao Granules

Sponsors

Hangzhou Hospital of Traditional Chinese Medicine Affiliated to Zhejiang Chinese Medical University
Lead Sponsor

Eligibility

Sex/Gender
Female
Age
25 Years to 45 Years

Inclusion criteria

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

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.

Design outcomes

Primary

MeasureTime frame
Serum levels of estradiol, testosterone, luteinizing hormone, follicle stimulating hormone and anti-Muller hormone;Antral follicle count;

Secondary

MeasureTime frame
Clinical pregnancy rate;Live birth rate;Pregnancy complications, miscarriage rate;

Countries

China

Contacts

Public ContactZhang Qin

Hangzhou Hospital of Traditional Chinese Medicine Affiliated to Zhejiang Chinese Medical University

zhqin@zjwh.gov.cn+86 18057129792

Outcome results

None listed

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