The goal of this clinical trial is to learn if a traditional Chinese herbal pretreatment can improve pregnancy outcomes in infertile women with diminished ovarian reserve (DOR) who are undergoing in vitro fertilization (IVF) or intracytoplasmic sperm injection (ICSI). The main question it aims to answer is:
• Does pretreatment with the Bushen Tongzhi Formula increase the cumulative clinical pregnancy rate from a single egg retrieval cycle compared to a placebo?
Researchers will compare the group taking the herbal formula to the group taking a placebo to see if the herbal formula is more effective.
Participants will:
* Take the assigned study medication (herbal formula or placebo) three times daily for 3 months before starting IVF/ICSI. * Continue taking the medication during their IVF/ICSI treatment cycle, for up to 6 months total. * Undergo standard IVF/ICSI procedures as planned by their doctor. * Have their pregnancy outcomes and health monitored through clinic visits and their medical records.
Women aged 22 to 39 years (inclusive).
Diagnosis of diminished ovarian reserve (DOR), defined by meeting at least two of the following three criteria: 1, Basal follicle-stimulating hormone (FSH) level between 10 and 25 IU/L (measured on menstrual cycle days 2-4); 2, Anti-Müllerian hormone (AMH) level < 1.1 ng/mL; 3, Antral follicle count (AFC) < 7 (total count of follicles 2-10 mm in diameter in both ovaries).
Diagnosis of infertility, defined as failure to achieve a clinical pregnancy after 12 months or more of regular unprotected sexual intercourse.
Diagnosis of Kidney Deficiency pattern according to Traditional Chinese Medicine criteria, as defined in the study protocol.
Uterine structural abnormalities likely to impair implantation or pregnancy (e.g., untreated submucosal fibroids, severe intrauterine adhesions, uterine septum).
Known abnormal karyotype in either partner.
Uncontrolled or severe medical conditions (e.g., hypertension, diabetes, thyroid dysfunction, hepatic/renal insufficiency, symptomatic heart disease).
Diagnosed severe psychiatric disorders (e.g., schizophrenia, bipolar disorder).