Acupuncture for Unexplained Subfertiliy
AURIS
A Randomized Controlled Trial of Acupuncture Versus Expectant Management in Women With Unexplained Infertility
1 other identifier
interventional
1,423
1 country
16
Brief Summary
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.
Trial Health
Trial Health Score
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participants targeted
Target at P75+ for not_applicable
16 active sites
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Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
November 24, 2015
CompletedStudy Start
First participant enrolled
December 1, 2015
CompletedFirst Posted
Study publicly available on registry
December 8, 2015
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 1, 2018
CompletedDecember 21, 2015
December 1, 2015
2.1 years
November 24, 2015
December 17, 2015
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
live birth rate
Up to 4 months
Secondary Outcomes (5)
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.
Up to 14 months
quality of life
Up to 14 months
Side effect
Up to 14 months
Study Arms (2)
Acupuncture plus expectant management
EXPERIMENTALexpectant management
ACTIVE COMPARATORInterventions
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.
Eligibility Criteria
You may qualify if:
- Women aged 18-40 years
- Bilateral patent tubes demonstrated by hysterosalpingogram, hysterosalpingo-contrast sonography or laparoscopy
- Regular menses 21 to 35 days Normal semen parameters :Total motile sperm count ≥10 million. (World Health Organization criteria, 2010)
You may not qualify if:
- Unwillingness to accept either of the two interventions
- Contra-indications to acupuncture: pacemaker use or bleeding disorder
- Received acupuncture before 2 months for other diseases which are not related to unexplained infertility.
- Previously received acupuncture for unexplained infertility
- Use of hormonal or other medication (including Chinese Herbal prescriptions) which may affect the outcome in the past 2 months.
- Patients who anticipate taking longer than a one month break from treatment during the trial (i.e. 4 months from randomization).
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (16)
Guangzhou Medical School First Affiliated Hospital
Guangzhou, Guangdong, China
The Daqing Oilfield General Hospital
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
MeSH Terms
Interventions
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY CHAIR
Xiaoke Wu, MD.PhD.
The First Affliated Hospital,Heilongjiang University of Chinese Medicine
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Director of obstetrics and gynecology
Study Record Dates
First Submitted
November 24, 2015
First Posted
December 8, 2015
Study Start
December 1, 2015
Primary Completion
January 1, 2018
Last Updated
December 21, 2015
Record last verified: 2015-12