Guishen Yijing Formula for Diminished Ovarian Reserve: A Real-World Retrospective Study

NCT07660692 | Completed

• 3 other identifiers: 2025DZMEC-598-02DZMG-ZLZX-2500690011461220907
• Study Type: observational
• Target: 126
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Diminished Ovarian Reserve (DOR)

Keywords

diminished ovarian reserve; traditional Chinese medicine; Real World Study

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (7)

• Serum Follicle-Stimulating Hormone (FSH)

  From baseline to 3 months after treatment initiation

• Serum Luteinizing Hormone (LH)

  From baseline to 3 months after treatment initiation

• FSH/LH Ratio

  From baseline to 3 months after treatment initiation

• Serum Estradiol (E2)

  From baseline to 3 months after treatment initiation

• Traditional Chinese Medicine Syndrome Score

  before and 1 month after the treatment

Other Outcomes (1)

• Pregnancy Rate

  From baseline to 3 months after treatment initiation

Interventions

Guishen Yijing Formula(Chinese herbal decoction) DRUG

Eligibility Criteria

• Age: 18 Years - 45 Years
• Gender Eligibility Details: biological
• Healthy Volunteers: No
• Age Groups: Adult (18-64)
• 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.

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Shi Yun: lead

Study Sites (1)

Dongzhimen Hospital, Beijing University of Chinese Medicine

Beijing, China

Location

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Head of Gynecology

Study Record Dates

• First Submitted: June 16, 2026
• First Posted: June 22, 2026
• Study Start: April 29, 2016
• Primary Completion: May 30, 2025
• Study Completion: May 30, 2025
• Last Updated: July 1, 2026

Record last verified: 2026-06

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)