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

This study has been completed.
Sponsor:
Information provided by:
Rigshospitalet, Denmark
ClinicalTrials.gov Identifier:
NCT00913354
First received: June 3, 2009
Last updated: NA
Last verified: November 2005
History: No changes posted
  Purpose

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 Intervention
Infertility
Device: Acupuncture (Carbo®)
Device: Placebo acupuncture (Strietberger®)

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
Primary Purpose: Treatment
Official Title: Acupuncture Versus Placebo Acupuncture During Ivf Embryo Transfer

Resource links provided by NLM:


Further study details as provided by Rigshospitalet, Denmark:

Primary Outcome Measures:
  • Clinical pregnancy rate [ Time Frame: 2005-2008 ] [ Designated as safety issue: No ]

Enrollment: 635
Study Start Date: November 2005
Study Completion Date: March 2009
Primary Completion Date: March 2007 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

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

  Eligibility

Ages Eligible for Study:   18 Years to 37 Years
Genders 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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00913354

Locations
Denmark
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
  More Information

No publications provided

Responsible Party: Dorthe Andersen, The Fertility Clinic, Copenhagen University Hospital, Denmark
ClinicalTrials.gov Identifier: NCT00913354     History of Changes
Other Study ID Numbers: Acupuncture001
Study First Received: June 3, 2009
Last Updated: June 3, 2009
Health Authority: Denmark: Ethics Committee

Keywords provided by Rigshospitalet, Denmark:
infertility
ivf
acupuncture

Additional relevant MeSH terms:
Infertility
Genital Diseases, Female
Genital Diseases, Male

ClinicalTrials.gov processed this record on November 24, 2014