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| Name | Class |
|---|---|
| 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 |
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This study aims to evaluate the superiority of an integrated traditional Chinese and Western medicine regimen ("Xiehe DOR Bushen Tongzhi Formula" + ovulation induction therapy with ovulation monitoring and timed intercourse) compared to standard treatment alone (placebo + ovulation induction therapy with ovulation monitoring and timed intercourse) in improving the natural cumulative clinical pregnancy rate in infertile patients with kidney deficiency-type diminished ovarian reserve (DOR).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Western medicine group | Placebo Comparator | Take the placebo granules orally for three months, followed by three cycles of letrozole while continuing the placebo. |
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| Integrated traditional Chinese and Western medicine | Experimental | 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Western Medicine | Drug | Letrozole is administered orally at 2.5 mg once daily from Day 2 to Day 5 of the menstrual cycle (5 consecutive days). |
|
| Measure | Description | Time Frame |
|---|---|---|
| Cumulative clinical pregnancy rate | The rate of intrauterine pregnancy confirmed by transvaginal ultrasound | Assessed at study completion, approximately 6 months after enrollment. |
| Measure | Description | Time Frame |
|---|---|---|
| Indicators related to ovarian reserve function | sex hormone levels(AMH, FSH), antral follicle count(AFC) | Baseline, 3-months, 6-months |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Yingying Guo, Doctor | Contact | 86+010-69158331 | guoyy28@gmail.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Peking union medical college hospital | Beijing | Beijing Municipality | 100730 | China |
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| The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School | OTHER |
| The First Affiliated Hospital of 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 |
| Affiliated Hospital of Shandong University of Traditional Chinese Medicine | OTHER |
| 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 |
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| Traditional Chinese Medicine | Drug | "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. |
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| Placebo | Drug | 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. |
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| ID | Term |
|---|---|
| D007246 | Infertility |
| ID | Term |
|---|---|
| D000091662 | Genital Diseases |
| D000091642 | Urogenital Diseases |
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| ID | Term |
|---|---|
| D008516 | Medicine, Chinese Traditional |
| ID | Term |
|---|---|
| D008518 | Medicine, East Asian Traditional |
| D008519 | Medicine, Traditional |
| D000529 | Complementary Therapies |
| D013812 | Therapeutics |
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