Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
NA
1423 participants
INTERVENTIONAL
2015-12-31
Brief Summary
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Detailed Description
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Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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Acupuncture plus expectant management
Acupuncture
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
expectant management
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.
expectant management
expectant management
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.
Interventions
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Acupuncture
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
expectant management
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.
Eligibility Criteria
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Inclusion Criteria
2. Bilateral patent tubes demonstrated by hysterosalpingogram, hysterosalpingo-contrast sonography or laparoscopy
3. Regular menses 21 to 35 days Normal semen parameters :Total motile sperm count ≥10 million. (World Health Organization criteria, 2010)
Exclusion Criteria
2. Contra-indications to acupuncture: pacemaker use or bleeding disorder
3. Received acupuncture before 2 months for other diseases which are not related to unexplained infertility.
4. Previously received acupuncture for unexplained infertility
5. Use of hormonal or other medication (including Chinese Herbal prescriptions) which may affect the outcome in the past 2 months.
6. Patients who anticipate taking longer than a one month break from treatment during the trial (i.e. 4 months from randomization).
18 Years
40 Years
FEMALE
No
Sponsors
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Heilongjiang University of Chinese Medicine
OTHER
Responsible Party
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Xiaoke Wu
Director of obstetrics and gynecology
Principal Investigators
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Xiaoke Wu, MD.PhD.
Role: STUDY_CHAIR
The First Affliated Hospital,Heilongjiang University of Chinese Medicine
Locations
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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
Shanxi Chinese Medicine Hospital
Shangxi, Shanxi, China
Shanxi Hospital of Chinese Medicine
Taiyuan, Shanxi, China
Tianjin Tanggu Maternity and Child Care Center
Tianjin, Tianjin Municipality, China
First Affiliated Hospital of Tianjin University of Chinese Medicine
Tianjin, Tianjin Municipality, China
Wenzhou Chinese Medicine Hospital
Wenzhou, Zhejiang, China
Hangzhou Chinese Medicine Hospital
Hangzhou, , China
Countries
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Central Contacts
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Facility Contacts
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Xiaoke Wu, MD.PhD.
Role: primary
Other Identifiers
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AURIS2015
Identifier Type: -
Identifier Source: org_study_id