Clinical Trial Details
— Status: Completed
Administrative data
NCT number |
NCT03973528 |
Other study ID # |
IRB201702097A3 |
Secondary ID |
Chang Gung MH |
Status |
Completed |
Phase |
Phase 3
|
First received |
|
Last updated |
|
Start date |
July 8, 2019 |
Est. completion date |
November 30, 2021 |
Study information
Verified date |
March 2022 |
Source |
Chang Gung Memorial Hospital |
Contact |
n/a |
Is FDA regulated |
No |
Health authority |
|
Study type |
Interventional
|
Clinical Trial Summary
This study is a preliminary evaluation of the efficacy of traditional Chinese medicine in the
treatment of elderly infertile women.
Description:
Research design: initial acceptance of 60 people, 30 in the no intervention group and 30 in
the experimental group.
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.