Diminished Ovarian Reserve (DOR)
Conditions
Interventions
QZYS Group:Qizi Yusi Granules
Control Group:Placebo
Sponsors
Affiliated Hospital of Shandong University of Traditional Chinese Medicine
Eligibility
Sex/Gender
Female
Age
35 Years to 44 Years
Inclusion criteria
Inclusion criteria: (1) Age = 35 years old; (2) Diminished ovarian reserve (DOR): basal antral follicle count (AFC) < 7 on ultrasound, serum basal follicle-stimulating hormone (FSH) 10-25 IU/L for two consecutive menstrual cycles, and serum anti-Müllerian hormone (AMH) < 1.1 ng/mL. At least two of the above three criteria must be met for a diagnosis of DOR; (3) Diagnosed with Kidney-Qi Deficiency Syndrome according to Traditional Chinese Medicine (TCM): 1) Main symptoms: infertility for a long time, light or sparse menstrual blood; 2) Concurrent symptoms: dizziness and tinnitus, decreased libido, lumbosacral pain, weakness and soreness of the legs and knees or heel pain; 3) Tongue and pulse: pale red tongue with thin white or scanty coating, deep and thready pulse in both chi positions. The main symptom is essential, and 2-3 concurrent symptoms must be met. Not all tongue or pulse characteristics are necessary. (4) First or second time undergoing IVF-ET treatment; (5) Voluntarily signed informed consent form.
Exclusion criteria
Exclusion criteria: (1) Age > 45 years old; (2) Body mass index (BMI) = 35kg/m2; (3) Congenital malformation of reproductive organs or acquired organic lesions; (4) Concomitant endocrine diseases such as polycystic ovarian syndrome, endometriosis, thyroid dysfunction, adrenal cortical hyperplasia, hyperprolactinemia, etc.; (5) Chromosomal structural or numerical abnormalities or a history of genetic diseases; (6) Use of other traditional Chinese medicine or steroidal hormones within the past three months; (7) Concomitant severe heart, liver, or kidney diseases or other systemic diseases; (8) Allergy to any component of the study medication.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Cumulative live birth rate; | — |
Secondary
| Measure | Time frame |
|---|---|
| Cycle Cancellation Rate;Number of Oocytes Retrieved;Embryo Implantation Rate;Pregnancy Loss Rate;Live Birth Rate; | — |
Countries
China
Contacts
Public ContactSun Zhen-Gao
Affiliated Hospital of Shandong University of Traditional Chinese Medicine
Outcome results
None listed