Back to resultsPregnancy Success Rates of Acupuncture for in Vitro Fertilization (Acupuncture)
Primary Purpose
Infertility, Female
Status
Unknown status
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
Acupuncture treatment
Sponsored by
About this trial
This is an interventional treatment trial for Infertility, Female focused on measuring acupuncture, infertility, pregnancy
Eligibility Criteria
Inclusion Criteria:
- To have unexplained infertility
- To go in vitro fertilization treatment
- To give permission by informed consent form
Exclusion Criteria:
- Below age of 18 and above age of 45
- To have secondary infertility
- To reject completing informed consent form
Sites / Locations
- Ataturk University Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
Acupuncture Treatment
Control Group
Arm Description
Acupuncture group will receive 3 acupuncture sessions. The first session will be one week before embryo transfer. The second session will be 30 minute before embryo transfer. And the last session will be 30 minute after embryo transfer.
Control Group will not receive any acupuncture session before or after embryo transfer.
Outcomes
Primary Outcome Measures
pregnancy
positive betaHCG
Secondary Outcome Measures
Anxiety level
STAI-1 Inventory
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT03572608
Brief Title
Pregnancy Success Rates of Acupuncture for in Vitro Fertilization
Acronym
Acupuncture
Official Title
Clinical Effectiveness of Acupuncture to Increase Pregnancy Success Rates for Women Undergoing in Vitro Fertilization: A Randomized Controlled Trial
Study Type
Interventional
2. Study Status
Record Verification Date
June 2018
Overall Recruitment Status
Unknown status
Study Start Date
June 1, 2018 (Actual)
Primary Completion Date
September 1, 2018 (Anticipated)
Study Completion Date
October 1, 2018 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Ataturk University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
This study evaluates the effectiveness of acupuncture on pregnancy success before embryo transfer in IVF treatment in female infertile patients. Half of participants will receive acupuncture sessions before embryo transfer, while the other half will not receive.
Detailed Description
Acupuncture is used for many health problem all around the World. WHO reported that acupuncture can have benefit in female infertility treatment. However, there is no enough evidence about effectiveness of acupuncture treatment in the infertility.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Infertility, Female
Keywords
acupuncture, infertility, pregnancy
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
120 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Acupuncture Treatment
Arm Type
Experimental
Arm Description
Acupuncture group will receive 3 acupuncture sessions. The first session will be one week before embryo transfer. The second session will be 30 minute before embryo transfer. And the last session will be 30 minute after embryo transfer.
Arm Title
Control Group
Arm Type
No Intervention
Arm Description
Control Group will not receive any acupuncture session before or after embryo transfer.
Intervention Type
Other
Intervention Name(s)
Acupuncture treatment
Intervention Description
Classical acupuncture points will be used without a formal traditional Chinese medicine diagnosis in the intervention group. Neither manual needle stimulation nor moxibustion will used. The needles will left in place for 30 min and de qi was not sought. The points will be selected bilateral Heart-7, bilateral Large Intestine-4, Governing Vessel-20 and ear shenmen for the first session. Bilateral Conception Vessel-3,4,6, bilateral Liver-3, bilateral Stomach-30, bilateral Spleen-6, bilateral Governing Vessel-20 will be used for the second session. Bilateral Large Intestine-4, bilateral Spleen-6,9, bilateral Stomach-36 will be used for the last session. All acupuncture points will be selected and localized on the basis of the WHO Standardised Acupuncture Point Location.
Primary Outcome Measure Information:
Title
pregnancy
Description
positive betaHCG
Time Frame
2 weeks after the treatment
Secondary Outcome Measure Information:
Title
Anxiety level
Description
STAI-1 Inventory
Time Frame
Through study completion, 2 weeks after the protocol
10. Eligibility
Sex
Female
Gender Based
Yes
Gender Eligibility Description
self-representation
Minimum Age & Unit of Time
23 Years
Maximum Age & Unit of Time
45 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
To have unexplained infertility
To go in vitro fertilization treatment
To give permission by informed consent form
Exclusion Criteria:
Below age of 18 and above age of 45
To have secondary infertility
To reject completing informed consent form
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Bunyamin Borekci
Organizational Affiliation
Ataturk University
Official's Role
Study Chair
Facility Information:
Facility Name
Ataturk University Hospital
City
Erzurum
ZIP/Postal Code
25040
Country
Turkey
12. IPD Sharing Statement
Learn more about this trial
Pregnancy Success Rates of Acupuncture for in Vitro Fertilization
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