Guishen Yijing Formula for Diminished Ovarian Reserve: A Real-World Retrospective Study (GSYJ;DOR)

Real-World Effectiveness of Guishen Yijing Formula in the Treatment of Diminished Ovarian Reserve: A Single-Center Retrospective Observational Study

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.

Study Overview

• Status: Completed
• Conditions: Diminished Ovarian Reserve (DOR)
• Intervention / Treatment: Drug: Guishen Yijing Formula(Chinese herbal decoction)

• Study Type: Observational
• Enrollment (Actual): 126

Contacts and Locations

Study Locations

• China
  • Beijing, China
    • Dongzhimen Hospital, Beijing University of Chinese Medicine

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

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.

Description

Inclusion Criteria:

Female patients aged 18 to 44 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

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in Serum Anti-Müllerian Hormone (AMH) Level	Change in serum AMH level before and after 3 months of treatment, measured by blood test.	From baseline to 3 months after treatment initiation

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Serum Follicle-Stimulating Hormone (FSH)	Blood samples are collected before and after treatment.	From baseline to 3 months after treatment initiation
Serum Luteinizing Hormone (LH)	Blood samples are collected before and after treatment.	From baseline to 3 months after treatment initiation
FSH/LH Ratio	Change in FSH/LH ratio before and after treatment.	From baseline to 3 months after treatment initiation
Serum Estradiol (E2)	Blood samples are collected before and after treatment.	From baseline to 3 months after treatment initiation
Traditional Chinese Medicine Syndrome Score	Change in TCM syndrome total score, main symptom score, and secondary symptom score before and after treatment.	before and 1 month after the treatment
Modified Kupperman Menopausal Index (KMI)	Change in total Modified Kupperman Index score before and after treatment, assessing menopausal-like symptoms.	before and 1 month after the treatment
Safety and Adverse Events	Adverse events occurring during treatment will be recorded, including gastrointestinal symptoms and any abnormalities in liver and renal function.	From baseline to 3 months after treatment initiation

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	From baseline to 3 months after treatment initiation

Collaborators and Investigators

• Sponsor: Shi Yun

Study record dates

Study Major Dates

• Study Start (Actual): April 29, 2016
• Primary Completion (Actual): May 30, 2025
• Study Completion (Actual): May 30, 2025

Study Registration Dates

• First Submitted: June 16, 2026
• First Submitted That Met QC Criteria: June 16, 2026
• First Posted (Actual): June 22, 2026

Study Record Updates

• Last Update Posted (Actual): June 22, 2026
• Last Update Submitted That Met QC Criteria: June 16, 2026
• Last Verified: June 1, 2026

More Information

Terms related to this study

• Keywords: traditional Chinese medicine; diminished ovarian reserve; Real World Study
• Other Study ID Numbers: 2025DZMEC-598-02; DZMG-ZLZX-25006 (Other Grant/Funding Number: Dongzhimen Hospital，Beijing University of Chinese Medicine); 90011461220907 (Other Grant/Funding Number: Beijing University of Chinese Medicine)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No