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

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: NCT00913354
Recruitment Status : Completed
First Posted : June 4, 2009
Last Update Posted : June 4, 2009
Sponsor:
Information provided by:
Rigshospitalet, Denmark

Study Description
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Brief Summary:
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

Condition or disease Intervention/treatment Phase
Infertility Device: Acupuncture (Carbo®) Device: Placebo acupuncture (Strietberger®) Not Applicable

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 Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 635 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
Official Title: Acupuncture Versus Placebo Acupuncture During Ivf Embryo Transfer
Study Start Date : November 2005
Actual Primary Completion Date : March 2007
Actual Study Completion Date : March 2009

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Arms and Interventions
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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 Name: 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 Name: Sham acupuncture needles: Strietberger® placebo-needle, Asia Med.


Outcome Measures
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Primary Outcome Measures :
  1. Clinical pregnancy rate [ Time Frame: 2005-2008 ]

Eligibility Criteria
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Ages Eligible for Study:   18 Years to 37 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

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
Contacts and Locations
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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): NCT00913354


Locations
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Denmark
The Fertility Clinic, Copenhagen University Hospital, Denmark
Copenhagen, Denmark, 2100
Sponsors and Collaborators
Rigshospitalet, Denmark
Investigators
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Principal Investigator: Dorthe Andersen, Study nurse The Fertility Clinic, Copenhagen University Hospital Rigshospitalet
More Information
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Responsible Party: Dorthe Andersen, The Fertility Clinic, Copenhagen University Hospital, Denmark
ClinicalTrials.gov Identifier: NCT00913354    
Other Study ID Numbers: Acupuncture001
First Posted: June 4, 2009    Key Record Dates
Last Update Posted: June 4, 2009
Last Verified: November 2005
Keywords provided by Rigshospitalet, Denmark:
infertility
ivf
acupuncture
Additional relevant MeSH terms:
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Infertility