Diminished Ovarian Reserve
Conditions
Interventions
Test group:Kuntai capsule
Control group:Kuntai capsule Granule Simulator
Sponsors
Hospital of Obstetrics and Gynecology, Fudan University
Eligibility
Sex/Gender
Female
Age
20 Years to 40 Years
Inclusion criteria
Inclusion criteria: 1. Intended participants for in vitro fertilization-embryo transfer; 2. Age range of 20 to 40 years; 3. Meet the criteria for diminished ovarian reserve as defined in the Poseidon (Patient-Oriented Strategies Encompassing IndividualizeD Oocyte Number) classification, groups 3 or 4 (antral follicle count <5 or AMH <1.2 ng/ml); 4. Menstrual cycle length of 24 to 35 days in the past 3 months; 5. Basal follicle-stimulating hormone (bFSH) level <20 IU/L; 6. Informed consent and voluntary participation. # : Venous blood drawn on days 2-4 of the menstrual cycle on an empty stomach.
Exclusion criteria
Exclusion criteria: 1. BMI = 28 kg/m^2; 2. History of two or more spontaneous abortions (excluding biochemical pregnancy loss) or three or more failed embryo transfers without achieving clinical pregnancy; 3. Untreated reproductive organ malformations or abnormalities; untreated intrauterine adhesions, endometrial lesions (endometritis, endometrial polyps, etc.), uterine fibroids > 4cm; untreated severe endometriosis (ASRM stage IV), including adenomyosis, ovarian chocolate cysts; untreated hydrosalpinx; 4. Coexisting reproductive endocrine or metabolic immune system diseases that affect ovarian reserve function or the assessment of drug efficacy, such as hyperprolactinemia, hyperandrogenism, poorly controlled thyroid disease (TSH outside the normal reference range), poorly controlled diabetes (HbA1c > upper limit of normal reference value), systemic lupus erythematosus, etc.; poorly controlled blood pressure (poorly controlled defined as systolic blood pressure = 160mmHg and/or diastolic blood pressure = 100mmHg); 5. History of chemotherapy, pelvic radiotherapy, or ovarian function decline due to surgery (e.g., ovarian surgery), unilateral ovarian absence, or incomplete development; 6. Male partner requiring surgical sperm retrieval or severe oligozoospermia (according to the "Chinese Expert Consensus on Oligozoospermia," criteria for severe oligozoospermia: PR (progressive motility) 1.5 times the upper limit of the normal reference value, or blood creatinine (Scr) > upper limit of normal reference value; 8. Coexisting severe cardiovascular, cerebrovascular, hepatic, renal, hematologic, or other systemic diseases, as well as mental illness or intellectual disabilities; 9. Glucose-6-phosphate dehydrogenase (G6PD) deficiency (favism) patients; (Note: berberine may have oxidative damage to red blood cells in patients with G6PD deficiency) 10. Yang deficiency constitution.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Antral follicle count;anti-Müllerian hormone; | — |
Secondary
| Measure | Time frame |
|---|---|
| Basic Sex Hormone;Endometrial thickness;Number of oocytes retrieved;Serum E2 on HCG day ;Total dose of Gn;Duration of Gn;MII oocyte rate;fertilized oocyte rate;D3 Available embryos;Good quality embryo rate on Day 3;Oocyte Utilization Rate;Blastocyst rate;Implantation rate;Clinical pregnancy rate;Rate of pregnancy loss;Cumulative live birth rate;Rate of cancellation cycles; | — |
Countries
China
Contacts
Public ContactHuang Hefeng
Hospital of Obstetrics and Gynecology, Fudan University
Outcome results
None listed