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.
연구 개요
연구 유형
등록 (실제)
연락처 및 위치
연구 장소
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Beijing, 중국
- Dongzhimen Hospital, Beijing University of Chinese Medicine
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참여기준
자격 기준
공부할 수 있는 나이
- 성인
건강한 자원 봉사자를 받아들입니다
샘플링 방법
연구 인구
설명
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
공부 계획
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디자인 세부사항
연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
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Change in Serum Anti-Müllerian Hormone (AMH) Level
기간: From baseline to 3 months after treatment initiation
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Change in serum AMH level before and after 3 months of treatment, measured by blood test.
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From baseline to 3 months after treatment initiation
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2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Serum Follicle-Stimulating Hormone (FSH)
기간: From baseline to 3 months after treatment initiation
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Blood samples are collected before and after treatment.
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From baseline to 3 months after treatment initiation
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Serum Luteinizing Hormone (LH)
기간: From baseline to 3 months after treatment initiation
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Blood samples are collected before and after treatment.
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From baseline to 3 months after treatment initiation
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FSH/LH Ratio
기간: From baseline to 3 months after treatment initiation
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Change in FSH/LH ratio before and after treatment.
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From baseline to 3 months after treatment initiation
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Serum Estradiol (E2)
기간: From baseline to 3 months after treatment initiation
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Blood samples are collected before and after treatment.
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From baseline to 3 months after treatment initiation
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Traditional Chinese Medicine Syndrome Score
기간: before and 1 month after the treatment
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Change in TCM syndrome total score, main symptom score, and secondary symptom score before and after treatment.
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before and 1 month after the treatment
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Modified Kupperman Menopausal Index (KMI)
기간: before and 1 month after the treatment
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Change in total Modified Kupperman Index score before and after treatment, assessing menopausal-like symptoms.
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before and 1 month after the treatment
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Safety and Adverse Events
기간: From baseline to 3 months after treatment initiation
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Adverse events occurring during treatment will be recorded, including gastrointestinal symptoms and any abnormalities in liver and renal function.
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From baseline to 3 months after treatment initiation
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기타 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Pregnancy Rate
기간: From baseline to 3 months after treatment initiation
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The proportion of participants with fertility needs who achieved pregnancy during the 3-month treatment period will be recorded as an exploratory outcome.
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From baseline to 3 months after treatment initiation
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공동 작업자 및 조사자
스폰서
연구 기록 날짜
연구 주요 날짜
연구 시작 (실제)
기본 완료 (실제)
연구 완료 (실제)
연구 등록 날짜
최초 제출
QC 기준을 충족하는 최초 제출
처음 게시됨 (실제)
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
QC 기준을 충족하는 마지막 업데이트 제출
마지막으로 확인됨
추가 정보
이 연구와 관련된 용어
기타 연구 ID 번호
- 2025DZMEC-598-02
- DZMG-ZLZX-25006 (기타 보조금/기금 번호: Dongzhimen Hospital，Beijing University of Chinese Medicine)
- 90011461220907 (기타 보조금/기금 번호: Beijing University of Chinese Medicine)
개별 참가자 데이터(IPD) 계획
개별 참가자 데이터(IPD)를 공유할 계획입니까?
약물 및 장치 정보, 연구 문서
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미국 FDA 규제 기기 제품 연구
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