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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UNKNOWN
NA
90 participants
INTERVENTIONAL
2023-06-01
2024-12-30
Brief Summary
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Detailed Description
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The trial is designed as a randomized, controlled clinical trial with two groups established by 1:1 equal allocation, a treatment group with interventions using acupuncture to tonify the kidneys and regulate blood and a control group treated using conventional Western medicine.
Random numbers will be prepared by an independent third-party statistician who prepared a list of random group codes for this study. Enrolled subjects will be given a subject number during the screening process and, upon formal enrolment, will be randomly assigned to either the test or control group with a corresponding random number.
The acupoints used will be:
Zhongwan (RN12) ：The needle should be punctured for 1-1.2 inches and retained for 30 minutes.
Qihai(RN6): The needle should be punctured for 1-1.2 inches and retained for 30 minutes.
Guanyuan(RN4): The needle should be punctured for 0.8-1.2 inches and retained for 30 minutes.
Zhongji(RN3): The needle should be punctured for 0.8-1.0 inches and retained for 30 minutes.
Guilai(ST29): The needle should be punctured for 0.8-1.0 inches and retained for 30 minutes.
Shenshu(BL23): The needle should be punctured for 0.8-1.0 inches and retained for 30 minutes.
Ciliao(BL28): The needle should be punctured for 1-1.2 inches and retained for 30 minutes.
Xuehai(SP10): The needle should be punctured for 1-1.5 inches and retained for 30 minutes.
Zusanli(ST36): The needle should be punctured for 1-1.5 inches and retained for 30 minutes.
Diji(SP8): The needle should be punctured for 1-1.2 inches and retained for 30 minutes.
Sanyinjiao(SP6): The needle should be punctured for 1-1.2 inches and retained for 30 minutes.
Taixi(KI6): The needle should be punctured for 0.8-1.2 inches and retained for 30 minutes.
Baihui(DU20): The needle should be punctured for 0.5-1.0 inches and retained for 30 minutes.
Yintang(EX-HN3): The needle should be punctured for 0.5-1.0 inches and retained for 30 minutes.
The Acupuncture intervention will start on the 5th day of the menstruation cycle, which will be carried out 1 time per day,at least 5 times a week, lasts for 10-15days. All operations were performed by experienced acupuncturists. After ET, both the control group and the treatment group will be treated with conventionally with no TCM intervention.
Serum human chorionic gonadotropin (hCG) will be measured, and an hCG\>30 IU will be considered to indicate biochemical pregnancy. Ultrasound monitoring will be performed 30 days after ET to calculate the clinical pregnancy rate.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
SINGLE
Study Groups
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Acupuncture treatment group
Method: Acupuncture at Zhongwan、Qihai、Guanyuan、Zhongji、Guilai、Shenshu、Ciliao、Xuehai、Sanyinjiao、Taixi. The acupuncture treatment starts on the 5th day of the menstrual cycle and lasts to the days before IVF-ET
Acupuncture
The Acupuncture intervention（Zhongwan、Qihai、Guanyuan、Zhongji、Guilai、Shenshu、Ciliao、Xuehai、Sanyinjiao、Taixi.） will start on the 5th day of menstruation cycle, which will be carried out 1 time per day, at least 5 times a week, lasts for 10-15days. All operations were performed by experienced acupuncturists. After ET, both the control group and the treatment group will be treated with conventionally with no TCM intervention.
Western medicine group
The western medicine group will be treated with conventional western medicine
Western medicine
Western medicine
Interventions
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Acupuncture
The Acupuncture intervention（Zhongwan、Qihai、Guanyuan、Zhongji、Guilai、Shenshu、Ciliao、Xuehai、Sanyinjiao、Taixi.） will start on the 5th day of menstruation cycle, which will be carried out 1 time per day, at least 5 times a week, lasts for 10-15days. All operations were performed by experienced acupuncturists. After ET, both the control group and the treatment group will be treated with conventionally with no TCM intervention.
Western medicine
Western medicine
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
2. Meet the criteria for identifying kidney deficiency in TCM.
3. Patients who Planning to undergo IVF-ET for pregnancy in our center, Age ≤40 years and ≥25 years.
4. Previous embryo transfer failure ≥ 2 times.
5. Menstrual cycle is basically normal, and normal ovulation has been monitored in the past.
6. There were more than 1 blastocyst /more than 2 high-quality embryos with more than 6 cells on day 3/more than 2 high-quality embryos with more than 4 cells on day 2.
7. Consent to participate in this clinical trial and sign an informed consent form.
Exclusion Criteria
2. It has been confirmed that there are obvious and serious other organic lesions in the reproductive organs.
3. Patients with allergic constitution
4. Infertility caused by genetic factors
5. Patients with serious primary diseases such as cardio cerebrovascular, kidney, liver and hematopoietic system and psychosis
6. A person who is unable to cooperate (such as a combination of neurological or mental illness, or a reluctance to cooperate)
7. The endometrial thickness on the day of hCG was less than 6 mm or the endometrial morphology on the day of hCG was type C
8. Those who did not agree to participate in the study
20 Years
40 Years
FEMALE
No
Sponsors
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Peking University Third Hospital
OTHER
Responsible Party
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Locations
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Peking University Third Hospital
Beijing, China, , China
Countries
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Central Contacts
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Facility Contacts
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xiyan C xin
Role: primary
Other Identifiers
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IRB00006761-M2020443
Identifier Type: -
Identifier Source: org_study_id
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