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

June 19, 2018 updated by: Yasemin Cayir, Ataturk University

Clinical Effectiveness of Acupuncture to Increase Pregnancy Success Rates for Women Undergoing in Vitro Fertilization: A Randomized Controlled Trial

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

120

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Turkey
      • Erzurum, Turkey, 25040
        • Ataturk University Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

23 years to 45 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
pregnancy
Time Frame: 2 weeks after the treatment
positive betaHCG
2 weeks after the treatment

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Anxiety level
Time Frame: Through study completion, 2 weeks after the protocol
STAI-1 Inventory
Through study completion, 2 weeks after the protocol

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Ataturk University

Investigators

  • Study Chair: Bunyamin Borekci, Ataturk University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 1, 2018

Primary Completion (Anticipated)

September 1, 2018

Study Completion (Anticipated)

October 1, 2018

Study Registration Dates

First Submitted

May 28, 2018

First Submitted That Met QC Criteria

June 19, 2018

First Posted (Actual)

June 28, 2018

Study Record Updates

Last Update Posted (Actual)

June 28, 2018

Last Update Submitted That Met QC Criteria

June 19, 2018

Last Verified

June 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • B.30.2.ATA.0.01.00/120

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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