An observational study in Diminished Ovarian Reserve (DOR), sponsored by Shi Yun. Completed at 1 site in China. Open to female participants aged 18 Years to 45 Years. Per ClinicalTrials.gov, last updated 2026-08-14.
Sponsored by Shi Yun · Observational
The goal of this observational study is to learn about the real-world effectiveness of Guishen Yijing Formula in women with diminished ovarian reserve (DOR). The main question it aims to answer is:
Does Guishen Yijing Formula improve ovarian reserve function in women with DOR after 3 months of treatment? Medical records of participants who received Guishen Yijing Formula as part of their routine clinical care for DOR will be reviewed. Changes in anti-Müllerian hormone (AMH), follicle-stimulating hormone (FSH), and symptom scores before and after treatment will be analyzed.
Female patients diagnosed with diminished ovarian reserve (DOR) who received Guishen Yijing Formula at the outpatient clinic of Dongzhimen Hospital, Beijing University of Chinese Medicine. Medical records were retrospectively reviewed from April 2016 to May 2025.
Female patients aged 18 to 45 years Diagnosed with diminished ovarian reserve (DOR) with TCM syndrome differentiation of Kidney Deficiency and Liver Stagnation, and serum AMH \< 1.1 ng/mL Received Guishen Yijing Formula with individualized modifications for 3 consecutive menstrual cycles
Exclusion Criteria:
Combined with serious systemic diseases, including cardiovascular, cerebrovascular, hematopoietic system disorders, or malignant tumors Primary amenorrhea, or family history of early menopause Diminished ovarian reserve caused by ovarian surgery or related surgical procedures Use of hormonal therapy or other treatments affecting ovarian function during the study period Pregnancy at baseline Incomplete medical records Loss to follow-up or significant missing data
Change in Serum Anti-Müllerian Hormone (AMH) Level
Change in serum AMH level before and after 3 months of treatment, measured by blood test.
Time frame: From baseline to 3 months after treatment initiation
Serum Follicle-Stimulating Hormone (FSH)
Blood samples are collected before and after treatment.
Time frame: From baseline to 3 months after treatment initiation
Serum Luteinizing Hormone (LH)
Blood samples are collected before and after treatment.
Time frame: From baseline to 3 months after treatment initiation
FSH/LH Ratio
Change in FSH/LH ratio before and after treatment.
Time frame: From baseline to 3 months after treatment initiation
Serum Estradiol (E2)
Blood samples are collected before and after treatment.
Time frame: From baseline to 3 months after treatment initiation
Traditional Chinese Medicine Syndrome Score
This syndrome score evaluates three primary symptoms and ten secondary symptoms related to traditional Chinese medicine syndrome differentiation. Total scores range from 0 to 48, with higher scores indicating more severe syndrome manifestations and a worse clinical outcome.
Time frame: before and 1 month after the treatment
Modified Kupperman Menopausal Index (KMI)
The modified KMI consists of 13 menopausal symptoms, each rated on a 0-3 severity scale and weighted by symptom-specific coefficients. Total scores range from 0 to 63, with higher scores indicating more severe menopausal symptoms and a worse clinical outcome.
Time frame: before and 1 month after the treatment
Incidence of Treatment-Emergent Adverse Events
The incidence of treatment-emergent adverse events during the treatment period will be assessed, including gastrointestinal symptoms and abnormalities in liver and renal function.
Time frame: From baseline to 3 months after treatment initiation
Pregnancy Rate
The proportion of participants with fertility needs who achieved pregnancy during the 3-month treatment period will be recorded as an exploratory outcome.
Time frame: From baseline to 3 months after treatment initiation
Plan to share: No
No publications or documents are linked to this record.
This study is completed, as verified in Jun 2026. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
Shi Yun