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The most successful treatment for infertility is in vitro fertilization (IVF), but less than 10% of infertile couples undergo IVF because of the high cost and relatively low success rate. Many patients have tried complementary and alternative medical treatments as an adjuvant therapy to improve their IVF success. Acupuncture given 2-4 times around the day of embryo transfer has not been shown to improve the IVF live birth rate. Chinese Herbal Medicine (CHM) may improve the IVF pregnancy rates, but the evidence so far is inconclusive because of high risks of bias in these studies.
The objective of this multi-centre double blind randomized trial is to evaluate the efficacy of acupuncture with or without CHM on the live birth of IVF. The randomization process will be coordinated through a central mechanism. A total of 2,728 subjects will be randomized in 1:1:1:1 ratio in to one of the four treatment arms: 1) acupuncture and CHM, 2) acupuncture and placebo CHM, 3) control acupuncture and CHM or 4) control acupuncture and placebo CHM. Women will receive acupuncture or control acupuncture three times a week 4 weeks prior to IVF during ovarian stimulation, and before and after the embryo transfer. They will also take CHM or placebo CHM daily 4 weeks prior to IVF till a negative pregnancy test or till 8 weeks of gestation if pregnant.
The objective of this multi-centre double blind randomized trial is to evaluate the efficacy of acupuncture with or without CHM on the live birth of IVF. The randomization process will be coordinated through a central mechanism. A total of 2,728 subjects will be randomized in 1:1:1:1 ratio in to one of the four treatment arms: 1) acupuncture and CHM, 2) acupuncture and placebo CHM, 3) control acupuncture and CHM or 4) control acupuncture and placebo CHM. Women will receive acupuncture or control acupuncture three times a week 4 weeks prior to IVF during ovarian stimulation, and before and after the embryo transfer. They will also take CHM or placebo CHM daily 4 weeks prior to IVF till a negative pregnancy test or till 8 weeks of gestation if pregnant.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| acupuncture and CHM | Experimental | Women will receive acupuncture three times a week 4 weeks prior to ovarian stimulation for IVF and during ovarian stimulation, and before and after embryo transfer (ET). They will also take CHM daily 4 weeks prior to IVF till the day of serum hCG testing. If the hCG testing is positive and a viable pregnancy is confirmed by transvaginal ultrasound, CHM will be continued till 8 weeks of gestation. If the hCG testing is negative or spontaneous miscarriage is confirmed, the drug treatment will be stopped. |
|
| acupuncture and placebo CHM | Placebo Comparator | Women will receive acupuncture three times a week 4 weeks prior to ovarian stimulation for IVF and during ovarian stimulation, and before and after ET. They will also take placebo CHM daily 4 weeks prior to IVF till the day of serum hCG testing. If the hCG testing is positive and a viable pregnancy is confirmed by transvaginal ultrasound, placebo CHM will be continued till 8 weeks of gestation. If the hCG testing is negative or spontaneous miscarriage is confirmed, the drug treatment will be stopped. |
|
| control acupuncture and CHM | Placebo Comparator | Women will receive control acupuncture three times a week 4 weeks prior to ovarian stimulation for IVF and during ovarian stimulation, and before and after ET. They will also take CHM daily 4 weeks prior to IVF till the day of serum hCG testing. If the hCG testing is positive and a viable pregnancy is confirmed by transvaginal ultrasound, CHM will be continued till 8 weeks of gestation. If the hCG testing is negative or spontaneous miscarriage is confirmed, the drug treatment will be stopped. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Acupuncture and Chinese Herbal Medicine | Other | 1) acupuncture and CHM, 2) acupuncture and placebo CHM, 3) control acupuncture and CHM or 4) control acupuncture and placebo CHM by an interactive online computer program in a central office. Using a 1:1:1:1 treatment ratio, there will be 682 women assigned to each treatment group. |
| Measure | Description | Time Frame |
|---|---|---|
| Live birth | Live birth defined as a delivery ≥20weeks gestation per transfer in the stimulated IVF cycles or in the first frozen-thawed embryo transfer cycle in those with elective freezing of all embryos | ≥20 weeks of gestation |
| Measure | Description | Time Frame |
|---|---|---|
| Embryo quality: embryo scoring standard | Embryo quality is judged by embryo scoring standard | On the third day after egg retrieval and before embryo transfer |
| Miscarriage rate | Cumulative miscarriage rate |
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Inclusion Criteria:
Exclusion Criteria:
Undergoing IVF
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Xiaoke Wu, Ph.D | Contact | 13796025599 | xiaokewu2002@vip.sina.com |
| Name | Affiliation | Role |
|---|---|---|
| Xiaoke Wu, Ph.D | First Affiliated Hospital in Heilongjiang University of Chinese Medicine | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The First Affiliated Hospital of Anhui Medical University | Hefei | Anhui | China |
Subject's privacy is protected undoubtedly at the time of the informed consent signing
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| control acupuncture and placebo CHM | Placebo Comparator | Women will receive control acupuncture three times a week 4 weeks prior to ovarian stimulation for IVF and during ovarian stimulation, and before and after ET. They will also take placebo CHM daily 4 weeks prior to IVF till the day of serum hCG testing. If the hCG testing is positive and a viable pregnancy is confirmed by transvaginal ultrasound, placebo CHM will be continued till 8 weeks of gestation. If the hCG testing is negative or spontaneous miscarriage is confirmed, the drug treatment will be stopped. |
|
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| ≤42 weeks of gestation |
| Implantation rate | Cumulative implantation rate | 2 weeks after embryo transfer |
| Positive serum human chorionic gonadotropin (hCG) level | Positive serum hCG level 2 weeks after embryo transfer | 2 weeks after embryo transfer |
| Ongoing pregnancy rate | Cumulative ongoing pregnancy rate | ≥8 weeks |
| Multiple pregnancy rate | Cumulative multiple pregnancy rate | ≥2 weeks after embryo transfer |
| Ectopic pregnancy rate | Cumulative ectopic pregnancy rate | ≥2 weeks after embryo transfer |
| Cumulative live birth rate | Cumulative live birth rate | within 6 months after randomization |
| Changes in markers of stress, anxiety | To elucidate the anxiety level as measured with serum cortisol concentration and Stait-Trait Anxiety Inventory (STAI) | ≤8 weeks of gestation |
| Health related quality of life(HRQoL) | To determine women's health related quality of life (HRQoL) by short-form 36 (SF36) | ≤8 weeks of gestation |
| Patient acceptability: acupuncture trust score | Patient acceptability of acupuncture to be measured by acupuncture trust score | On the day of embryo transfer |
| Side effects | Side effects | ≤ 8 weeks of gestation |
| Congenital abnormalities | Judging by prenatal ultrasound and postnatal physical examination | at 6 weeks postpartum |
| Pregnancy complications | Complications of Pregnancy | ≤42 weeks of gestation |
| The First Hospital of Lanzhou University | Lanzhou | Gansu | China |
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| The First Affiliated Hospital of Zhengzhou University | Zhengzhou | Henan | China |
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| Tongji Hospital, Tongji Medical College Huazhong University of Science & Technology | Wuhan | Hubei | China |
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| Huaian Maternal and Child Health Hospital | Huai'an | Jiangsu | China |
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| The First Affiliated Hospital of Nanjing University Medical School (Nanjing Drum Tower Hospital) | Nanjing | Jiangsu | China |
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| Xuzhou Central Hospital | Xuzhou | Jiangsu | China |
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| Jiangxi Maternal and Child Health Hospital | Nanchang | Jiangxi | China |
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| Dalian Municipal Women and Children's Medical Center | Dalian | Liaoning | China |
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| Shengjing Hospital of China Medical University | Shenyang | Liaoning | China |
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| Xibei Women and Children's Hospital | Xi’an | Shanxi | China |
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| The Chinese University of Hong Kong | Hong Kong | China |
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| ID | Term |
|---|---|
| D015670 | Acupuncture Therapy |
| ID | Term |
|---|---|
| D000529 | Complementary Therapies |
| D013812 | Therapeutics |
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