Diminished Ovarian Reserve (DOR)GSYJ;DORNCT07660692
Guishen Yijing Formula for Diminished Ovarian Reserve: A Real-World Retrospective Study
An observational study of Diminished Ovarian Reserve (DOR), run by Shi Yun at 1 site in China.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 45 years, women only
- Conditions the study is for
- Diminished Ovarian Reserve (DOR)
- What is being tested?
- Guishen Yijing Formula(Chinese herbal decoction)
- How many people
- 126 participants
- Where
- 1 siteChina
- Study dates
- 29 Apr 2016to 30 May 2025
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 45 years
- Women only
- No healthy volunteers
- Adult
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.
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
- Conditions
- Diminished Ovarian Reserve (DOR)
- Being tested
- Guishen Yijing Formula(Chinese herbal decoction)
- Keywords
- diminished ovarian reserve, traditional Chinese medicine, Real World Study
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Guishen Yijing Formula(Chinese herbal decoction)Drug
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Serum Anti-Müllerian Hormone (AMH) Level
Change in serum AMH level before and after 3 months of treatment, measured by blood test.
Measured: From baseline to 3 months after treatment initiation
Secondary outcomes (7)
Serum Follicle-Stimulating Hormone (FSH)
Blood samples are collected before and after treatment.
Measured: From baseline to 3 months after treatment initiation
Serum Luteinizing Hormone (LH)
Blood samples are collected before and after treatment.
Measured: From baseline to 3 months after treatment initiation
FSH/LH Ratio
Change in FSH/LH ratio before and after treatment.
Measured: From baseline to 3 months after treatment initiation
Serum Estradiol (E2)
Blood samples are collected before and after treatment.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: From baseline to 3 months after treatment initiation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jun 2026
- Study start29 Apr 2016
- Primary completion30 May 2025
- Study completion30 May 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Diminished Ovarian Reserve (DOR)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 126 participants (actual)
Sponsor and investigators
- Lead sponsor
- Shi Yun
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Shi Yun, Dongzhimen Hospital, Beijing
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07660692
- Sponsor's protocol ID
- 2025DZMEC-598-02
- Other IDs
- DZMG-ZLZX-25006, 90011461220907
- Acronym
- GSYJ;DOR
- Status last verified
- Jun 2026
- First submitted
- 16 Jun 2026
- Last updated
- 14 Aug 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Real-World Effectiveness of Guishen Yijing Formula in the Treatment of Diminished Ovarian Reserve: A Single-Center Retrospective Observational Study
- ClinicalTrials.gov ID
- NCT07660692
- Acronym / sponsor ID
- GSYJ;DOR / 2025DZMEC-598-02
- Conditions
- Diminished Ovarian Reserve (DOR)
- Keywords
- diminished ovarian reserve, traditional Chinese medicine, Real World Study
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 126 participants (actual)
- Lead sponsor
- Shi YunUniversity, hospital or other
- Study start
- 29 Apr 2016 (actual)
- Primary completion
- 30 May 2025 (actual)
- Study completion
- 30 May 2025 (actual)
- First posted
- 22 Jun 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Retrospective
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
- 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.
Key inclusion criteria (1 listed)
- 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
Key exclusion criteria (1 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Guishen Yijing Formula(Chinese herbal decoction) | Drug | – |
Primary outcome
Change in Serum Anti-Müllerian Hormone (AMH) Level
Time frame: From baseline to 3 months after treatment initiation
Change in serum AMH level before and after 3 months of treatment, measured by blood test.
7 secondary outcomes
Serum Follicle-Stimulating Hormone (FSH)
Time frame: From baseline to 3 months after treatment initiation
Serum Luteinizing Hormone (LH)
Time frame: From baseline to 3 months after treatment initiation
FSH/LH Ratio
Time frame: From baseline to 3 months after treatment initiation
Serum Estradiol (E2)
Time frame: From baseline to 3 months after treatment initiation
Traditional Chinese Medicine Syndrome Score
Time frame: before and 1 month after the treatment
Modified Kupperman Menopausal Index (KMI)
Time frame: before and 1 month after the treatment
Incidence of Treatment-Emergent Adverse Events
Time frame: From baseline to 3 months after treatment initiation
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Aug 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Diminished Ovarian Reserve (DOR), run by Shi Yun at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 14 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Serum Anti-Müllerian Hormone (AMH) Level (time frame: From baseline to 3 months after treatment initiation). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Aug 2026.