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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
2,728
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.
The First Affiliated Hospital of Anhui Medical University
Hefei, Anhui, China
The First Hospital of Lanzhou University
Lanzhou, Gansu, China
The First Affiliated Hospital of Zhengzhou University
Zhengzhou, Henan, China
Tongji Hospital, Tongji Medical College Huazhong University of Science & Technology
Wuhan, Hubei, China
Huaian Maternal and Child Health Hospital
Huai'an, Jiangsu, China
The First Affiliated Hospital of Nanjing University Medical School (Nanjing Drum Tower Hospital)
Nanjing, Jiangsu, China
Xuzhou Central Hospital
Xuzhou, Jiangsu, China
Jiangxi Maternal and Child Health Hospital
Nanchang, Jiangxi, China
Dalian Municipal Women and Children's Medical Center
Dalian, Liaoning, China
Shengjing Hospital of China Medical University
Shenyang, Liaoning, China
...and 2 more locations
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
Time frame: ≥20 weeks of gestation
Embryo quality: embryo scoring standard
Embryo quality is judged by embryo scoring standard
Time frame: On the third day after egg retrieval and before embryo transfer
Miscarriage rate
Cumulative miscarriage rate
Time frame: ≤42 weeks of gestation
Implantation rate
Cumulative implantation rate
Time frame: 2 weeks after embryo transfer
Positive serum human chorionic gonadotropin (hCG) level
Positive serum hCG level 2 weeks after embryo transfer
Time frame: 2 weeks after embryo transfer
Ongoing pregnancy rate
Cumulative ongoing pregnancy rate
Time frame: ≥8 weeks
Multiple pregnancy rate
Cumulative multiple pregnancy rate
Time frame: ≥2 weeks after embryo transfer
Ectopic pregnancy rate
Cumulative ectopic pregnancy rate
Time frame: ≥2 weeks after embryo transfer
Cumulative live birth rate
Cumulative live birth rate
Time frame: 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)
Time frame: ≤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)
Time frame: ≤8 weeks of gestation
Patient acceptability: acupuncture trust score
Patient acceptability of acupuncture to be measured by acupuncture trust score
Time frame: On the day of embryo transfer
Side effects
Side effects
Time frame: ≤ 8 weeks of gestation
Congenital abnormalities
Judging by prenatal ultrasound and postnatal physical examination
Time frame: at 6 weeks postpartum
Pregnancy complications
Complications of Pregnancy
Time frame: ≤42 weeks of gestation
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