Shoutai Pill: The experimental group took Shoutai Pills, 20 pills each time, twice daily, taken with water, continuously for 3 months
Placebo: The experimental group took placebo Pills, 20 pills each time, twice daily, taken with water, continuously for 3 months
Study summary
Grounded in the 'disease-syndrome combination' paradigm, this study endeavors to address the pivotal scientific issues pertaining to the clinical precision of Traditional Chinese Medicine (TCM) in managing Diminished Ovarian Reserve (DOR) classified as the Kidney Essence Deficiency type, through the application of systems biology technologies, including metabolomics.
Eligibility
Sex
FEMALE
Min age
20 Years
Max age
50 Years
Healthy volunteers
No
Inclusion Criteria:
1. The inclusion criteria are as follows: ① meeting the above-mentioned integrated Chinese and Western medicine diagnostic criteria for DOR
2. ② no use of estrogen-containing medications within the past 1 month
3. ③ patients scheduled to undergo IVF-ET
4. ④ provision of signed informed consent, voluntary participation, and good compliance.
Exclusion Criteria:
1. The exclusion criteria are as follows: ① patients with polycystic ovary syndrome (PCOS) or stage III/IV endometriosis
2. ② uterine conditions including untreated submucous myomas, intramural myomas \>4 cm in diameter, intrauterine adhesions, uterine septum, or other uterine anomalies
3. ③ couples undergoing preimplantation genetic diagnosis (PGD) for genetic reasons
4. ④ body mass index (BMI) ≥28 kg/m²
5. ⑤ history of prior pelvic radiotherapy or cytotoxic chemotherapy
6. ⑥ significant systemic diseases, such as uncontrolled hypertension, diabetes mellitus, thyroid dysfunction, hepatic or renal insufficiency, cardiac disorders, or autoimmune diseases
7. ⑦ use of medications that may interfere with this study within the past 1 month, including but not limited to estrogens, hepatic enzyme modulators, and agents that may affect the endocrine system (hormonal drugs)
8. ⑧ known allergy to any components of the study medication
9. and ⑨ participation in another drug trial within the past 3 months. -
Primary outcome measure(s)
Number of MII oocyte — After 3 months of medication, ovulation induction was performed, followed by oocyte retrieval upon completion of the induction cycle. The number of mature oocytes was recorded on the day of retrieval. On the day of oocyte retrieval, the number of mature oocytes was observed under a microscope. Mature oocytes are defined as oocytes containing the first polar body.
Trial sites (1)
Facility
City
Region
Status
Peking Union Medical College Hospital
Beijing
Beijing Municipality
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This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
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