The Effect of Acupuncture on Pregnancy Rates in Women Undergoing Embryo Transfer (AcuIVF)

July 7, 2015 updated by: Ottawa Fertility Centre

The Effect of Acupuncture on Pregnancy Rates in Women Undergoing Embryo Transfer After in Vitro Fertilization: A Prospective Randomized Sham-controlled Trial

The present study is designed to test the hypothesis that acupuncture, before and after embryo transfer, significantly improves pregnancy rates, compared to embryo transfer with sham acupuncture and no acupuncture at all.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

30

Phase

  • Phase 4

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

  • Canada
    • Ontario
      • Ottawa, Ontario, Canada, K2C 3V4
        • Ottawa Fertility Centre

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

  • ADULT
  • OLDER_ADULT
  • CHILD

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

Female

Description

Inclusion Criteria:

  • patient is undergoing embryo transfer after IVF or ICSI
  • patient has given informed consent to participate

Exclusion Criteria:

  • frozen embryo transfer
  • previous enrollment in study

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
  • Masking: QUADRUPLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: 1
Active acupuncture
Procedure: Active acupuncture
Acupuncture 25 minutes before and after embryo transfer
SHAM_COMPARATOR: 2
Sham Acupuncture- acupuncture at neutral points
Procedure: Sham acupuncture
Acupuncture at neutral points, 25 minutes before and after embryo transfer
NO_INTERVENTION: 3
Embryo transfer with no acupuncture

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Clinical Pregnancy
Time Frame: 4-5 weeks after treatment
4-5 weeks after treatment

Secondary Outcome Measures

Outcome Measure
Time Frame
Live birth
Time Frame: 9 months after treatment
9 months after treatment
Implantation rate
Time Frame: 4-5 weeks after treatment
4-5 weeks after treatment
Side effects with acupuncture treatment
Time Frame: 2 weeks after treatment
2 weeks after treatment

Collaborators and Investigators

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

Sponsor

Ottawa Fertility Centre

Investigators

  • Study Chair: Arthur Leader, MD, Ottawa Fertility Centre
  • Principal Investigator: Doron Shmorgun, MD, Ottawa Fertility Centre

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

August 1, 2008

Primary Completion (ACTUAL)

May 1, 2009

Study Completion (ACTUAL)

May 1, 2009

Study Registration Dates

First Submitted

July 23, 2008

First Submitted That Met QC Criteria

July 24, 2008

First Posted (ESTIMATE)

July 25, 2008

Study Record Updates

Last Update Posted (ESTIMATE)

July 9, 2015

Last Update Submitted That Met QC Criteria

July 7, 2015

Last Verified

July 1, 2015

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • OttawaFC

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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