Primary Efficacy Evaluation of Traditional Chinese Medicine in Treating Older Infertile Women
NCT ID: NCT03973528
Last Updated: 2022-03-22
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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COMPLETED
PHASE3
17 participants
INTERVENTIONAL
2019-07-08
2021-11-30
Brief Summary
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Detailed Description
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The no intervention group no use Traditional Chinese medicine. The experimental group use Traditional Chinese medicine. Affect natural pregnancy and IVF success factors, the quality of ovarian function plays a very important role. Currently used to predict ovarian follicle inventory indicators, including: age, the total number of small sized ovarian follicles, the first three days of menstrual follicle-stimulating hormone, Anti-Mullerian hormone, inhibin-B.
Research Analysis Chang Gung Memorial Hospital infertility patients using traditional Chinese medicine, more than 40-year-old infertility patients, the most commonly used compound is Zuo Gui Wan. Chinese medicine believes that elderly women with infertility ovulation poor, the main pathogenesis of kidney deficiency. The proportion of domestic infertility patients has increased year by year. Traditional Chinese medicine had become popular and acceptable, but the substantial evidence and treatment consensus of infertility are scanty.
Due to the outbreak of the new crown pneumonia epidemic, which made it difficult to accept the case. Only 17 subjects in the experimental group completed the test. The average age of the subjects was 40.11 ±3.09 years old, and 9 of them were over 40 years old. The AMH before the test was all below 1.2. After three months of treatment with traditional Chinese medicine, 16 subjects had an increase in the number of small sized ovarian follicles. The average total number of small ovarian follicles before the test was 3.06±0.90, and the average increased to 4.53±1.46 after treatment. (P\<0.05), which was statistically significant. Eleven subjects showed a decrease in follicle-stimulating hormone on the third day of menstruation after treatment, 9 subjects showed an increase in anti-Mullerian hormone (AMH) value after treatment, and 3 subjects had anti-Mullerian hormone (AMH) values higher than 1.2 after treatment, but they did not reach statistical significance.
Conditions
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Study Design
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NON_RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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traditional Chinese medicine
The experimental group use traditional Chinese medicine
traditional Chinese medicine: tonifying kidney Wan
traditional Chinese medicine : tonifying kidney Wan
non- traditional Chinese medicine
The no intervention group no use traditional Chinese medicine.
No interventions assigned to this group
Interventions
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traditional Chinese medicine: tonifying kidney Wan
traditional Chinese medicine : tonifying kidney Wan
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
B. Blood tests for serum anti-Mullerian hormone ( AMH) less than 1.2, female hormones FSH, LH, E2 blood test is normal.
C. Women who are not planning for IUI or IVF in the next three months. D. Menstrual cycle rules 21-35 days. E. Willing to sign a written consent form.
Exclusion Criteria
D. Because of the need for disease, it is currently necessary to take western medicine for more than three months.
E. Women with abnormal liver function (GOT, GPT greater than 2 times the upper limit of normal).
F. Women with abnormal renal function (serum creatinine \> 1.5 mg/dl). G. Poor compliance with medication. H. In the past month, take a Traditional Chinese medicine to treat infertility. I. Take DHEA for the past month.
35 Years
45 Years
FEMALE
No
Sponsors
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Chang Gung Memorial Hospital
OTHER
Responsible Party
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Principal Investigators
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Tsang-Tang Hsieh, MD
Role: STUDY_CHAIR
Chang Gung MH IRB
Locations
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Chang Gung Memorial Hospital
Taoyuan District, , Taiwan
Countries
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Other Identifiers
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Chang Gung MH
Identifier Type: OTHER_GRANT
Identifier Source: secondary_id
IRB201702097A3
Identifier Type: -
Identifier Source: org_study_id
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