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Infertility affects one in six couples. In a quarter of them, routine tests of semen quality, ovulation or tubal patency fail to reveal any abnormalities and the cause of infertility is unexplained. Acupuncture is being increasingly used by couples with all types of infertility and initial trials have suggested that it could be potentially beneficial in some cases. A number of systematic reviews of acupuncture in IVF have shown conflicting results, but there is no evidence to inform best practice in unexplained infertility. In addition, as an intervention, acupuncture is not cost neutral as it involves multiple visits for treatment sessions delivered by a skilled practitioner. Thus, while acupuncture could have the potential to increase live birth rates in women with unexplained infertility, the clinical and cost effectiveness of acupuncture needs to be confirmed in the context of a large randomized controlled trial.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Acupuncture plus expectant management | Experimental |
| |
| expectant management | Active Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Acupuncture | Other | semi-fixed protocol will be used including four local core points; conception vessel (CV) 3, CV 6, and stomach (ST) 29 bilaterally and four in the leg/feet; spleen (SP) 6, and SP 9 bilaterally. The core points CV 3, CV 6, ST 29, SP 6, and SP 9 are thereafter connected to electrical stimulator (Hwoto, China) and stimulated with low-frequency, 2Hz, 0.5 ms |
| Measure | Description | Time Frame |
|---|---|---|
| live birth rate | Up to 4 months |
| Measure | Description | Time Frame |
|---|---|---|
| pregnancy rate | Up to 14 months | |
| Miscarriage rate | Up to 14 months | |
| Other pregnancy complications such as early pregnancy loss, gestational diabetes mellitus, pregnancy-induced hypertension and birth of small-for-gestational-age (SGA) babies. |
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Inclusion criteria
Exclusion criteria
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Hui Chang, MD | Contact | changhui1903@sina.com |
| Name | Affiliation | Role |
|---|---|---|
| Xiaoke Wu, MD.PhD. | The First Affliated Hospital,Heilongjiang University of Chinese Medicine | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Guangzhou Medical School First Affiliated Hospital | Guangzhou | Guangdong | China | |||
| The Daqing Oilfield General Hospital |
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| ID | Term |
|---|---|
| D015670 | Acupuncture Therapy |
| D057832 | Watchful Waiting |
| ID | Term |
|---|---|
| D000529 | Complementary Therapies |
| D013812 | Therapeutics |
| D017063 | Outcome Assessment, Health Care |
| D010043 | Outcome and Process Assessment, Health Care |
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|
| expectant management | Other | one initial counselling session, an information leaflet on timed intercourse, access to a telephone helpline for queries and ad hoc support on demand from the fertility clinic over a period of 4 months post randomization. |
|
| Up to 14 months |
| quality of life | Up to 14 months |
| Side effect | Up to 14 months |
| Daqing |
| Heilongjiang |
| 163000 |
| China |
| Daqing Longnan hospital | Daqing | Heilongjiang | China |
| Daqing Oilfield General Hospital | Daqing | Heilongjiang | China |
| Department of Obstetrics and Gynecology,First Affliated Hospital,Heilongjiang University of Chinese Medicine . | Harbin | Heilongjiang | 150040 | China |
| Obstetrics and Gynecology,Heilongjiang University of Chinese Medicine | Harbin | Heilongjiang | 150040 | China |
|
| First Affiliated Hospital of Hunan University of Chinese | Changsha | Hunan | China |
| Maternal and Child Health Hospital of Xuzhou | Xuzhou | Jiangsu | China |
| Jiangxi University of Chinese Medicine Affiliated Hospital | Nanchang | Jiangxi | 330000 | China |
| First Hospital, Jiangxi college of Chinese Medicine | Nanchang | Jiangxi | China |
| Shanxi Chinese Medicine Hospital | Shangxi | Shanxi | 030012 | China |
| Shanxi Hospital of Chinese Medicine | Taiyuan | Shanxi | China |
| Tianjin Tanggu Maternity and Child Care Center | Tianjin | Tianjin Municipality | 300451 | China |
| First Affiliated Hospital of Tianjin University of Chinese Medicine | Tianjin | Tianjin Municipality | China |
| Wenzhou Chinese Medicine Hospital | Wenzhou | Zhejiang | 325000 | China |
| Hangzhou Chinese Medicine Hospital | Hangzhou | 310000 | China |
| D011787 | Quality of Health Care |
| D006298 | Health Services Administration |