Clinical Study on ShouTai Pills for Improving Reduced Ovarian Reserve
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Shoutai Pill, Placebo.
- Who it may be relevant to
- Registry conditions: Diminished Ovarian Reserve (DOR). Basic parameters: 20 years — 50 years · Female.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- China
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
A Study on Biological Subtyping of Reduced Ovarian Reserve With Kidney Essence Deficiency Syndrome Based on Follicular Fluid Metabolomics and Efficacy Prediction of ShouTai Pills
Overview
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.
Interventions
- Drug Shoutai Pill
The experimental group took Shoutai Pills, 20 pills each time, twice daily, taken with water, continuously for 3 months - Drug Placebo
The experimental group took placebo Pills, 20 pills each time, twice daily, taken with water, continuously for 3 months
Primary outcome measures
- Number of MII oocyte [Time frame: 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.]
Secondary outcome measures (6)
- FSH [Time frame: Basline， and after 3 months of treatment]
- AMH [Time frame: Basline， and after 3 months of treatment]
- number of oocytes retrieved [Time frame: 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.]
- AFC [Time frame: Basline， and after 3 months of treatment]
- blastocyst formation rate [Time frame: After 3 months of medication, ovulation induction and oocyte retrieval for fertilization are performed, recorded as Day 0. Blastocysts form on days 5/6 post-fertilization; thus, the blastocyst formation rate is assessed on Day 6]
- proportion of good-quality embryos [Time frame: After 3 months of medication, ovulation induction and oocyte retrieval for fertilization are performed, recorded as Day 0. Cleavage embryos form on day3 post-fertilization; thus, the rate is assessed on Day 3]
Eligibility criteria
Inclusion criteria
- The inclusion criteria are as follows: ① meeting the above-mentioned integrated Chinese and Western medicine diagnostic criteria for DOR
- ② no use of estrogen-containing medications within the past 1 month
- ③ patients scheduled to undergo IVF-ET
- ④ provision of signed informed consent, voluntary participation, and good compliance.
Exclusion criteria
- The exclusion criteria are as follows: ① patients with polycystic ovary syndrome (PCOS) or stage III/IV endometriosis
- ② uterine conditions including untreated submucous myomas, intramural myomas >4 cm in diameter, intrauterine adhesions, uterine septum, or other uterine anomalies
- ③ couples undergoing preimplantation genetic diagnosis (PGD) for genetic reasons
- ④ body mass index (BMI) ≥28 kg/m²
- ⑤ history of prior pelvic radiotherapy or cytotoxic chemotherapy
- ⑥ significant systemic diseases, such as uncontrolled hypertension, diabetes mellitus, thyroid dysfunction, hepatic or renal insufficiency, cardiac disorders, or autoimmune diseases
- 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 known allergy to any components of the study medication
- and ⑨ participation in another drug trial within the past 3 months. -
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Single blind
- Primary purpose
- Treatment
Study locations
China · 1 center
- Peking Union Medical College Hospital — Beijing
Identifiers
NCT: NCT07737847 · I-26PJ0867 · 首发 2026-2-4019