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Acupuncture for Unexplained Subfertiliy (AURIS)

Primary Purpose

Unexplained Infertility

Status
Unknown status
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
Acupuncture
expectant management
Sponsored by
Heilongjiang University of Chinese Medicine
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Unexplained Infertility focused on measuring unexplained infertility, Acupuncture

Eligibility Criteria

18 Years - 40 Years (Adult)FemaleDoes not accept healthy volunteers

Inclusion criteria

  1. Women aged 18-40 years
  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

  1. Unwillingness to accept either of the two interventions
  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).

Sites / Locations

  • Guangzhou Medical School First Affiliated Hospital
  • The Daqing Oilfield General Hospital
  • Daqing Longnan hospital
  • Daqing Oilfield General Hospital
  • Department of Obstetrics and Gynecology,First Affliated Hospital,Heilongjiang University of Chinese Medicine .
  • Obstetrics and Gynecology,Heilongjiang University of Chinese Medicine
  • First Affiliated Hospital of Hunan University of Chinese
  • Maternal and Child Health Hospital of Xuzhou
  • Jiangxi University of Chinese Medicine Affiliated Hospital
  • First Hospital, Jiangxi college of Chinese Medicine
  • Shanxi Chinese Medicine Hospital
  • Shanxi Hospital of Chinese Medicine
  • Tianjin Tanggu Maternity and Child Care Center
  • First Affiliated Hospital of Tianjin University of Chinese Medicine
  • Wenzhou Chinese Medicine Hospital
  • Hangzhou Chinese Medicine Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Acupuncture plus expectant management

expectant management

Arm Description

Outcomes

Primary Outcome Measures

live birth rate

Secondary Outcome Measures

pregnancy rate
Miscarriage rate
Other pregnancy complications such as early pregnancy loss, gestational diabetes mellitus, pregnancy-induced hypertension and birth of small-for-gestational-age (SGA) babies.
quality of life
Side effect

Full Information

First Posted
November 24, 2015
Last Updated
December 17, 2015
Sponsor
Heilongjiang University of Chinese Medicine
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1. Study Identification

Unique Protocol Identification Number
NCT02624076
Brief Title
Acupuncture for Unexplained Subfertiliy
Acronym
AURIS
Official Title
A Randomized Controlled Trial of Acupuncture Versus Expectant Management in Women With Unexplained Infertility
Study Type
Interventional

2. Study Status

Record Verification Date
December 2015
Overall Recruitment Status
Unknown status
Study Start Date
December 2015 (undefined)
Primary Completion Date
January 2018 (Anticipated)
Study Completion Date
undefined (undefined)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Heilongjiang University of Chinese Medicine

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Unexplained Infertility
Keywords
unexplained infertility, Acupuncture

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
1423 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Acupuncture plus expectant management
Arm Type
Experimental
Arm Title
expectant management
Arm Type
Active Comparator
Intervention Type
Other
Intervention Name(s)
Acupuncture
Intervention Description
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
Intervention Type
Other
Intervention Name(s)
expectant management
Intervention Description
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.
Primary Outcome Measure Information:
Title
live birth rate
Time Frame
Up to 4 months
Secondary Outcome Measure Information:
Title
pregnancy rate
Time Frame
Up to 14 months
Title
Miscarriage rate
Time Frame
Up to 14 months
Title
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
Title
quality of life
Time Frame
Up to 14 months
Title
Side effect
Time Frame
Up to 14 months

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
40 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion criteria 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) Exclusion criteria 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).
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Hui Chang, MD
Email
changhui1903@sina.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Xiaoke Wu, MD.PhD.
Organizational Affiliation
The First Affliated Hospital,Heilongjiang University of Chinese Medicine
Official's Role
Study Chair
Facility Information:
Facility Name
Guangzhou Medical School First Affiliated Hospital
City
Guangzhou
State/Province
Guangdong
Country
China
Facility Name
The Daqing Oilfield General Hospital
City
Daqing
State/Province
Heilongjiang
ZIP/Postal Code
163000
Country
China
Facility Name
Daqing Longnan hospital
City
Daqing
State/Province
Heilongjiang
Country
China
Facility Name
Daqing Oilfield General Hospital
City
Daqing
State/Province
Heilongjiang
Country
China
Facility Name
Department of Obstetrics and Gynecology,First Affliated Hospital,Heilongjiang University of Chinese Medicine .
City
Harbin
State/Province
Heilongjiang
ZIP/Postal Code
150040
Country
China
Facility Name
Obstetrics and Gynecology,Heilongjiang University of Chinese Medicine
City
Harbin
State/Province
Heilongjiang
ZIP/Postal Code
150040
Country
China
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Xiaoke Wu, MD.PhD.
Phone
86-451-8213 0094
Email
xiaokewu2002@vip.sina.com
First Name & Middle Initial & Last Name & Degree
Xiaoke Wu, MD.PhD.
Facility Name
First Affiliated Hospital of Hunan University of Chinese
City
Changsha
State/Province
Hunan
Country
China
Facility Name
Maternal and Child Health Hospital of Xuzhou
City
Xuzhou
State/Province
Jiangsu
Country
China
Facility Name
Jiangxi University of Chinese Medicine Affiliated Hospital
City
Nanchang
State/Province
Jiangxi
ZIP/Postal Code
330000
Country
China
Facility Name
First Hospital, Jiangxi college of Chinese Medicine
City
Nanchang
State/Province
Jiangxi
Country
China
Facility Name
Shanxi Chinese Medicine Hospital
City
Shangxi
State/Province
Shanxi
ZIP/Postal Code
030012
Country
China
Facility Name
Shanxi Hospital of Chinese Medicine
City
Taiyuan
State/Province
Shanxi
Country
China
Facility Name
Tianjin Tanggu Maternity and Child Care Center
City
Tianjin
State/Province
Tianjin
ZIP/Postal Code
300451
Country
China
Facility Name
First Affiliated Hospital of Tianjin University of Chinese Medicine
City
Tianjin
State/Province
Tianjin
Country
China
Facility Name
Wenzhou Chinese Medicine Hospital
City
Wenzhou
State/Province
Zhejiang
ZIP/Postal Code
325000
Country
China
Facility Name
Hangzhou Chinese Medicine Hospital
City
Hangzhou
ZIP/Postal Code
310000
Country
China

12. IPD Sharing Statement

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Acupuncture for Unexplained Subfertiliy

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