Acupuncture Versus Placebo Acupuncture During In Vitro Fertilization (IVF) Embryo Transfer

June 3, 2009 updated by: Rigshospitalet, Denmark

Acupuncture Versus Placebo Acupuncture During Ivf Embryo Transfer

During IVF treatment, acupuncture at the time of embryo transfer may improve the pregnancy rate. This study aims to compare IVF pregnancy between two groups of patients that received either acupuncture or sham acupuncture (placebo)around embryo transfer

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Acupuncture at the time of embryo transfer may improve the IVF pregnancy rate. This study aims to compare the IVF pregnancy between two groups of patients that undergo ivf/icsi treatment. The patients are randomized to receive either acupuncture or sham acupuncture (placebo)around embryo transfer

Study Type

Interventional

Enrollment (Actual)

635

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

  • Denmark
      • Copenhagen, Denmark, 2100
        • The Fertility Clinic, Copenhagen University Hospital, Denmark

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

18 years to 37 years (ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

Inclusion Criteria:

  • infertility
  • below 38 years
  • ivf or icsi treatment
  • fresh embryo transfer cycle
  • no more than two earlier embryo transfers with "fresh" embryos
  • embryo transfer on day 2 or 3 after oocyte aspiration, single or double embryo transfer

Exclusion Criteria:

  • Frozen embryo transfer
  • oocyte donation
  • other "alternative" treatment during the cycle

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: SINGLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: 1
30 minutes of acupuncture just before and just after embryo replacement
Device: Acupuncture (Carbo®)
The acupuncture points were chosen according to traditional Chinese medicine and included DU20, M29, KS6, Mp8, and Le3 before embryo transfer and DU20, Co4, Mp10, M36, and Mp6 after embryo transfer.
Other Names:
  • Acupuncture needles: Carbo® needle,Acupharma A/S.
PLACEBO_COMPARATOR: 2
Sham acupuncture for 30 minutes just before and just after embryo transfer
Device: Placebo acupuncture (Strietberger®)

The acupuncture points were the same as in the true acupuncture group, namely DU20, M29, KS6, Mp8, and Le3 before embryo transfer and DU20, Co4, Mp10, M36, and Mp6 after embryo transfer.

Sham acupuncture needles used were the validated Strietberger® placebo-needle from the company, Asia Med. The needle is not fixed inside the copper handle and its tip is blunt. When the needle touches the skin it moves inside the handle and appears to be shortened. A pricking sensation is felt by the patient, simulating the puncturing of the skin. Developed by dr. Konrad Streitberger.

Other Names:
  • Sham acupuncture needles: Strietberger® placebo-needle, Asia Med.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Clinical pregnancy rate
Time Frame: 2005-2008
2005-2008

Collaborators and Investigators

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

Sponsor

Rigshospitalet, Denmark

Investigators

  • Principal Investigator: Dorthe Andersen, Study nurse, The Fertility Clinic, Copenhagen University Hospital Rigshospitalet

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

November 1, 2005

Primary Completion (ACTUAL)

March 1, 2007

Study Completion (ACTUAL)

March 1, 2009

Study Registration Dates

First Submitted

June 3, 2009

First Submitted That Met QC Criteria

June 3, 2009

First Posted (ESTIMATE)

June 4, 2009

Study Record Updates

Last Update Posted (ESTIMATE)

June 4, 2009

Last Update Submitted That Met QC Criteria

June 3, 2009

Last Verified

November 1, 2005

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Acupuncture001

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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