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

This study has been terminated.
(Recent abstract publication questioning the need for our study)
Sponsor:
Information provided by:
Ottawa Fertility Centre
ClinicalTrials.gov Identifier:
NCT00722462
First received: July 23, 2008
Last updated: June 29, 2009
Last verified: June 2009
History of Changes
  Purpose

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.


Condition Intervention Phase
Pregnancy
 Procedure: Active acupuncture
Procedure: Sham acupuncture
 Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: The Effect of Acupuncture on Pregnancy Rates in Women Undergoing Embryo Transfer After in Vitro Fertilization: A Prospective Randomized Sham-Controlled Trial

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Ottawa Fertility Centre:

Primary Outcome Measures:
  • Clinical Pregnancy [ Time Frame: 4-5 weeks after treatment ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Live birth [ Time Frame: 9 months after treatment ] [ Designated as safety issue: No ]
  • Implantation rate [ Time Frame: 4-5 weeks after treatment ] [ Designated as safety issue: No ]
  • Side effects with acupuncture treatment [ Time Frame: 2 weeks after treatment ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 580
Study Start Date: August 2008
Estimated Study Completion Date: December 2009
Estimated Primary Completion Date: February 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00722462

Locations
Canada, Ontario
Ottawa Fertility Centre
Ottawa, Ontario, Canada, K2C 3V4
Sponsors and Collaborators
Ottawa Fertility Centre
Investigators
Study Chair: Arthur Leader, MD Ottawa Fertility Centre
Principal Investigator: Doron Shmorgun, MD Ottawa Fertility Centre
  More Information

No publications provided

Responsible Party: Dr. Doron Shmorgun, Ottawa Fertility Centre
ClinicalTrials.gov Identifier: NCT00722462     History of Changes
Other Study ID Numbers: OttawaFC
Study First Received: July 23, 2008
Last Updated: June 29, 2009
Health Authority: Canada: Health Canada
Canada: Canadian Institutes of Health Research

Keywords provided by Ottawa Fertility Centre:
Infertility
IVF
Acupuncture

ClinicalTrials.gov processed this record on May 21, 2013