Clinical Evaluation of Integrated Chinese-Western Medicine for Infertility With DOR Patients in Women Achieving Natural Pregnancy
NCT ID: NCT07296614
Last Updated: 2025-12-22
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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NOT_YET_RECRUITING
PHASE3
320 participants
INTERVENTIONAL
2025-12-25
2028-07-30
Brief Summary
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Detailed Description
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Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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Western medicine group
Take the placebo granules orally for three months, followed by three cycles of letrozole while continuing the placebo.
Western Medicine
Letrozole is administered orally at 2.5 mg once daily from Day 2 to Day 5 of the menstrual cycle (5 consecutive days).
Placebo
The appearance and packaging of the placebo are exactly the same as those of "Xiehe DOR Kidney-Tonifying Universal Formula". It is also taken by dissolving one sachet in hot water, three times daily.
Integrated traditional Chinese and Western medicine
Take the "Xiehe DOR Kidney-Tonifying Universal Formula" orally for three months; thereafter, continue the Chinese herbal formula while combining it with three cycles of letrozole.
Western Medicine
Letrozole is administered orally at 2.5 mg once daily from Day 2 to Day 5 of the menstrual cycle (5 consecutive days).
Traditional Chinese Medicine
"Xiehe DOR Kidney-Tonifying Universal Formula" is a traditional Chinese medicine (TCM) granule formulation prepared in-hospital. It is taken by dissolving one sachet in hot water, three times daily.
Interventions
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Western Medicine
Letrozole is administered orally at 2.5 mg once daily from Day 2 to Day 5 of the menstrual cycle (5 consecutive days).
Traditional Chinese Medicine
"Xiehe DOR Kidney-Tonifying Universal Formula" is a traditional Chinese medicine (TCM) granule formulation prepared in-hospital. It is taken by dissolving one sachet in hot water, three times daily.
Placebo
The appearance and packaging of the placebo are exactly the same as those of "Xiehe DOR Kidney-Tonifying Universal Formula". It is also taken by dissolving one sachet in hot water, three times daily.
Eligibility Criteria
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Inclusion Criteria
2. Meet the diagnostic criteria for diminished ovarian reserve (requiring at least two of the following: Basal FSH 10-25 IU/L; AMH \< 1.1 ng/mL; AFC \< 7) and infertility(defined as the failure to achieve pregnancy after 12 months of regular unprotected sexual intercourse).
3. Meet the diagnostic criteria for kidney deficiency syndrome in traditional Chinese medicine
4. Voluntarily participate in this study and provide written informed consent.
Exclusion Criteria
2. Infertility caused by organic lesions of the fallopian tubes, uterus, cervix, etc.
3. Infertility due to male factors (based on semen analysis reports, meeting the diagnostic criteria for oligoasthenoteratozoospermia according to the WHO 5th edition standards).
4. DOR caused by iatrogenic factors (such as pelvic surgery, radiotherapy/chemotherapy, uterine artery embolization, etc.).
5. Patients with severe primary diseases of the cardiovascular, cerebrovascular, hepatic, renal, or hematopoietic systems, or psychiatric disorders.
6. Individuals with known allergies to the investigational drug or its components.
7. Use of hormonal medications (e.g., estrogen, contraceptive drugs) within one month prior to enrollment, or use of kidney-tonifying Chinese herbal medicines or proprietary Chinese medicinal products within one month prior to enrollment.
8. Patients currently participating in or planning to participate in other clinical trials.
22 Years
39 Years
FEMALE
No
Sponsors
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Dongfang Hospital Beijing University of Chinese Medicine
OTHER
Beijing University of Chinese Medicine
OTHER
The First Affiliated Hospital of Tianjin University of Traditional Chinese Medicine
OTHER
The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School
OTHER
Hunan University of Traditional Chinese Medicine
OTHER
Shandong University
OTHER
Xiamen University
OTHER
Beijing Obstetrics and Gynecology Hospital
OTHER
Xiyuan Hospital of China Academy of Chinese Medical Sciences
OTHER
The Third Affiliated Hospital of Beijing University of Chinese Medicine
OTHER
Hunan Provincial Maternal and Child Health Care Hospital
OTHER
Guangdong Provincial Hospital of Traditional Chinese Medicine
OTHER
The Affiliated Hospital of Shandong University of Traditional Chinese Medicine
UNKNOWN
Institute of Basic Medical Sciences CAMS
UNKNOWN
First Affiliated Hospital of Heilongjiang Chinese Medicine University
OTHER
Shunde Women and Children's Hospital (Maternity and Child Healthcare Hospital of Shunde Foshan)
UNKNOWN
The First Affiliated Hospital of Zhengzhou University
OTHER
Shenyang Women's and Children's Hospital
UNKNOWN
Peking Union Medical College Hospital
OTHER
Responsible Party
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Locations
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Peking union medical college hospital
Beijing, Beijing Municipality, China
Countries
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Central Contacts
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Other Identifiers
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K9220
Identifier Type: -
Identifier Source: org_study_id