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Pregnancy Success Rates of Acupuncture for in Vitro Fertilization (Acupuncture)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03572608
Recruitment Status : Active, not recruiting
First Posted : June 28, 2018
Last Update Posted : June 28, 2018
Sponsor:
Information provided by (Responsible Party):
Yasemin Cayir, Ataturk University

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.

Condition or disease Intervention/treatment Phase
Infertility, Female Other: Acupuncture treatment Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 120 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Clinical Effectiveness of Acupuncture to Increase Pregnancy Success Rates for Women Undergoing in Vitro Fertilization: A Randomized Controlled Trial
Actual Study Start Date : June 1, 2018
Estimated Primary Completion Date : September 1, 2018
Estimated Study Completion Date : October 1, 2018

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Acupuncture Treatment
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.
Other: Acupuncture treatment
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.

No Intervention: Control Group
Control Group will not receive any acupuncture session before or after embryo transfer.



Primary Outcome Measures :
  1. pregnancy [ Time Frame: 2 weeks after the treatment ]
    positive betaHCG


Secondary Outcome Measures :
  1. Anxiety level [ Time Frame: Through study completion, 2 weeks after the protocol ]
    STAI-1 Inventory



Information from the National Library of Medicine

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Ages Eligible for Study:   23 Years to 45 Years   (Adult)
Sexes Eligible for Study:   Female
Gender Based Eligibility:   Yes
Gender Eligibility Description:   self-representation
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03572608


Locations
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Turkey
Ataturk University Hospital
Erzurum, Turkey, 25040
Sponsors and Collaborators
Ataturk University
Investigators
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Study Chair: Bunyamin Borekci Ataturk University

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Responsible Party: Yasemin Cayir, Assoc. Prof. Yasemin Cayir, Ataturk University
ClinicalTrials.gov Identifier: NCT03572608     History of Changes
Other Study ID Numbers: B.30.2.ATA.0.01.00/120
First Posted: June 28, 2018    Key Record Dates
Last Update Posted: June 28, 2018
Last Verified: June 2018

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Yasemin Cayir, Ataturk University:
acupuncture
infertility
pregnancy
Additional relevant MeSH terms:
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Infertility
Infertility, Female
Genital Diseases, Male
Genital Diseases, Female