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

Sponsor
Rigshospitalet, Denmark (Other)
Overall Status
Completed
CT.gov ID
NCT00913354
Collaborator
(none)
635
Enrollment
1
Location
2
Arms
40
Duration (Months)
15.9
Patients Per Site Per Month

Study Details

Study Description

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
  • Device: Acupuncture (Carbo®)
  • Device: Placebo acupuncture (Strietberger®)
 N/A

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

Study Type:
Interventional
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 :
Nov 1, 2005
Actual Primary Completion Date :
Mar 1, 2007
Actual Study Completion Date :
Mar 1, 2009

Arms and Interventions

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.

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Clinical pregnancy rate [2005-2008]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 37 Years
    Sexes Eligible for Study:
    Female
    Accepts Healthy Volunteers:
    No
    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

    Locations

    Site City State Country Postal Code
    1 The Fertility Clinic, Copenhagen University Hospital, Denmark Copenhagen Denmark 2100

    Sponsors and Collaborators

    • Rigshospitalet, Denmark

    Investigators

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

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    , ,
    ClinicalTrials.gov Identifier:
    NCT00913354
    Other Study ID Numbers:
    • Acupuncture001
    First Posted:
    Jun 4, 2009
    Last Update Posted:
    Jun 4, 2009
    Last Verified:
    Nov 1, 2005
    Keywords provided by , ,
    infertility
    ivf
    acupuncture
    Additional relevant MeSH terms:
    Infertility

    Study Results

    No Results Posted as of Jun 4, 2009