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The randomized, placebo-controlled multicenter trial is conducted in five centers in China. After screening and obtaining the signed informed consent , the participants are randomly divided into three groups: acupuncture group (Acu.+IVF),sham acupuncture group(Sham Acu. +IVF),and the control group (only IVF).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Acupuncture group | Experimental | Acupuncture + IVF. |
|
| Sham acupuncture group | Sham Comparator | Sham acupuncture +IVF. We formulate and follow standardised step-by-step instructions and operations to use the same rituals in the acupuncture and sham acupuncture groups as far as possible. |
|
| control group | Other | only IVF |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| acupuncture and IVF | Device | Acupuncture was performed three times a week for 30 minutes each time, starting from the 5th day of menstruation before the cycle of the transfer and ending within 24 hours after embryo transfer. |
| Measure | Description | Time Frame |
|---|---|---|
| CPR | Clinical pregnancy rate | 1 year |
| Measure | Description | Time Frame |
|---|---|---|
| OPR | ongoing pregnancy rate | 1 year |
| LBR | Live birth rate | 1 year |
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Inclusion Criteria:
Exclusion Criteria:
Patients who met any of the following conditions were not included.
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Cuihong Zheng, professor | Contact | 86-27-83663275 | chzheng@tjh.tjmu.edu.cn |
| Name | Affiliation | Role |
|---|---|---|
| Minming Zhang, professor | Huazhong University of Science and Technology | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Tongji Hospital,Tongji medical college,HUST | Recruiting | Wuhan | Hubei | 430030 | China |
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| ID | Term |
|---|---|
| D015670 | Acupuncture Therapy |
| D035061 | Control Groups |
| ID | Term |
|---|---|
| D000529 | Complementary Therapies |
| D013812 | Therapeutics |
| D015340 | Epidemiologic Research Design |
| D004812 | Epidemiologic Methods |
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To maintain blinding in patients, outcome assessors, and statisticians, the allocation sequence was concealed until the end of the study.
| sham acupuncture and IVF | Device | Sham acupuncture was performed three times a week for 30 minutes each time, starting from the 5th day of menstruation before the cycle of the transfer and ending within 24 hours after embryo transfer. |
|
| control group | Other | no acupuncture, only IVF |
|
| Biochemical indexes |
Biochemical indexes |
| before and after acupuncture treatment |
| Questionnaire score | Questionnaire score | before and after acupuncture treatment |
| β-HCG positive rate | level of serum β-HCG positive rate | 1 year |
| D008919 | Investigative Techniques |
| D012107 | Research Design |
| D008722 | Methods |