Diminished ovarian reserve (Pattern of Qi and Blood Deficiency)
Conditions
Interventions
Treatment Group:Ejiao Composite Syrup
Control Group:Ejiao Composite Syrup Mimetic Agent
Sponsors
Dongzhimen Hospital Affiliated to Beijing University of Chinese Medicine
Eligibility
Sex/Gender
Female
Age
25 Years to 39 Years
Inclusion criteria
Inclusion criteria: 1. Aged 25-39 years old (including boundary value) female; 2. Meet the diagnostic criteria of diminished ovarian reserve; 3. In accordance with the diagnostic criteria of less menstrual period of TCM; The TCM syndrome differentiation type was "Pattern of Qi and Blood Deficiency". 4. Anti-Müllerian Hormone (AMH) <1.1 ng/ml (1 ng/ml = 7.14 pmol/L); 5. 21days < menstrual cycle < 35 days,1 day <= menstrual period <= 7 days; 6. No history of intrauterine operation or systemic hormone therapy within 3 months before treatment; 7. Voluntarily sign the informed consent form of the subjects.
Exclusion criteria
Exclusion criteria: 1. Diminished Ovarian Reserve (DOR) caused by iatrogenic factors such as ovarian surgery, radiotherapy/chemotherapy, and In Vitro Fertilization (IVF); DOR caused by systemic lupus erythematosus, mumps and other primary diseases; 2. Adnexal mass (cystic mass >= 4cm or solid mass), endometrial polyps > 1cm, uterine fibroids > 3cm; 3. Breast hyperplasia requiring treatment; 4. Premature menstruation caused by uterine congenital malformation, dysplasia, organic lesions of reproductive organs, or intrauterine operation; 5. Complicated with serious primary diseases of the heart, brain, lung, liver, kidney, nervous system and hematopoietic system; 6. Serum Creatinine (SCr) > upper limit of normal, Alanine Aminotransferase (ALT)/Aspartate Aminotransferase (AST), AST) or Alanine Phosphatase (ALP) >= 1.5 times upper limit of normal (ULN); 7. Persons with intellectual disability or mental illness; 8. Patients who are allergic to the study drugs or ingredients; 9. During pregnancy or lactation; 10. Planned pregnancy during the trial to 1 month after the end of the trial; 11. Those who participated in other clinical trials within the past one month; 12. If the investigator considered it inappropriate to participate in the study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The change in serum Anti-Müllerian Hormone (AMH) levels from baseline after treatment over 3 menstrual cycles; | — |
Secondary
| Measure | Time frame |
|---|---|
| The change in the Pictorial Blood Loss Assessment Chart (PBAC) score from baseline after 1, 2, and 3 menstrual cycles of treatment.;The change in FSH levels from baseline after 1, 2, and 3 menstrual cycles of treatment.;Normalization rate of FSH;The change in serum Anti-Müllerian Hormone (AMH) levels from baseline after 1 and 2 menstrual cycles of treatment.;The changes in serum Luteinizing Hormone (LH), Prolactin (PRL), Progesterone (P), Estradiol (E2), total Testosterone (T), and the FSH/LH ratio from baseline after 1, 2, and 3 menstrual cycles of treatment.;The change in Antral Follicle Count (AFC) from baseline after 1, 2, and 3 menstrual cycles of treatment.;The change in the total score of the Pittsburgh Sleep Quality Index (PSQI) from baseline after 1, 2, and 3 menstrual cycles of treatment.;The efficacy of TCM (Traditional Chinese Medicine) syndrome treatment after 1, 2, and 3 menstrual cycles; | — |
Countries
China
Contacts
Public ContactYun Shi
Dongzhimen Hospital Affiliated to Beijing University of Chinese Medicine
Outcome results
None listed