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).
Parallel
Bushen Tongzhi Formula
DrugBushen Tongzhi Formula is a standardized, fixed-composition herbal formula developed based on Traditional Chinese Medicine (TCM) principles for treating diminished ovarian reserve due to kidney deficiency. It is composed of multiple herbal ingredients processed into a granulated formulation. The dosage is 20g of granules taken orally three times daily. It serves as the active comparator against an indistinguishable placebo in this trial.
Placebo Pretreatment plus Standard IVF/ICSI
DrugIntervention: Participants in this arm receive the control treatment, consisting of an oral placebo combined with a standard IVF/ICSI protocol. Details: Medication: Matched placebo granules. These contain no active herbal ingredients and are formulated from inert materials (e.g., dextrin, food-grade flavorings/colorants) to precisely mimic the appearance, taste, smell, and packaging of the active Bushen Tongzhi Formula granules. Dosage \& Administration: 20g (one sachet), taken orally three times daily after meals. Treatment Regimen: The regimen is identical to the experimental arm: a 3-month pretreatment phase, followed by continued placebo intake concurrently throughout the subsequent IVF/ICSI treatment cycle. The maximum total duration is 6 months, with medication stopping upon confirmation of clinical pregnancy. Concurrent Procedure: Participants undergo the same standard, clinic-directed IVF/ICSI procedures.
Cumulative clinical pregnancy rate from a single oocyte retrieval cycle
This outcome measures the proportion of participants in each treatment group who achieve a clinical pregnancy resulting from a single oocyte retrieval procedure. A clinical pregnancy is defined as the ultrasound confirmation of an intrauterine gestational sac with cardiac activity. The rate is "cumulative" because it includes pregnancies achieved from both the initial fresh embryo transfer and any subsequent frozen-thawed embryo transfer(s) utilizing all embryos derived from that single retrieval cycle. Data will be collected until no embryos from the index cycle remain for transfer or a clinical pregnancy is confirmed.
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