Skip to main content
OpenTrials
Completed

NCT Number: NCT07660692

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

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Diminished Ovarian Reserve (DOR)

Age range

18 year–45 year

Sex eligibility

Female

Study type

Observational

Primary location

Dongzhimen Hospital, Beijing University of Chinese Medicine

Beijing, China

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Guishen Yijing Formula(Chinese herbal decoction)

Drug

Primary outcomes

  1. 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.

Secondary outcomes

  1. Serum Follicle-Stimulating Hormone (FSH)

    Time frame: From baseline to 3 months after treatment initiation

    Blood samples are collected before and after treatment.

  2. Serum Luteinizing Hormone (LH)

    Time frame: From baseline to 3 months after treatment initiation

    Blood samples are collected before and after treatment.

  3. FSH/LH Ratio

    Time frame: From baseline to 3 months after treatment initiation

    Change in FSH/LH ratio before and after treatment.

  4. Serum Estradiol (E2)

    Time frame: From baseline to 3 months after treatment initiation

    Blood samples are collected before and after treatment.

  5. Traditional Chinese Medicine Syndrome Score

    Time frame: before and 1 month after the treatment

    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.

  6. Modified Kupperman Menopausal Index (KMI)

    Time frame: before and 1 month after the treatment

    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.

  7. Incidence of Treatment-Emergent Adverse Events

    Time frame: From baseline to 3 months after treatment initiation

    The incidence of treatment-emergent adverse events during the treatment period will be assessed, including gastrointestinal symptoms and abnormalities in liver and renal function.

Other outcomes

  1. Pregnancy Rate

    Time frame: From baseline to 3 months after treatment initiation

    The proportion of participants with fertility needs who achieved pregnancy during the 3-month treatment period will be recorded as an exploratory outcome.

Sponsors and collaborators

Lead sponsor

Shi Yun

Other

Registry information

Official study title

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

Acronym: GSYJ;DOR

Important dates

Study start
2016
Primary completion
2025
Study completion
2025
First posted
Jun 22, 2026
Registry last updated
Jul 1, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.