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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
1,423
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
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.
Guangzhou Medical School First Affiliated Hospital
Guangzhou, Guangdong, China
The Daqing Oilfield General Hospital
Daqing, Heilongjiang, 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, China
Obstetrics and Gynecology,Heilongjiang University of Chinese Medicine
Harbin, Heilongjiang, 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, China
First Hospital, Jiangxi college of Chinese Medicine
Nanchang, Jiangxi, China
...and 6 more locations
live birth rate
Time frame: Up to 4 months
pregnancy rate
Time frame: Up to 14 months
Miscarriage rate
Time frame: 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.
Time frame: Up to 14 months
quality of life
Time frame: Up to 14 months
Side effect
Time frame: Up to 14 months
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