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In Vitro Fertilization (IVF) and Acupuncture for Infertility

This study has been terminated.
(Adjustments to ensure clear outcomes and scientific merit integrated. Study closed at 14 subjects. New protocol submitted to IRB.)
Sponsor:
Information provided by:
Pacific Fertility Center
ClinicalTrials.gov Identifier:
NCT00736411
First received: August 13, 2008
Last updated: April 4, 2011
Last verified: April 2011
History of Changes
  Purpose

The aim of this investigation is to determine the value of combining acupuncture with infertility patients undergoing In Vitro Fertilization (IVF). The investigators will measure the outcomes of endometrial lining, uterine blood flow, hormones, stress levels, and pregnancy and live birth rates.


Condition Intervention
Infertility
 Procedure: acupuncture
Procedure: IVF

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: IVF and Acupuncture for Infertility: A Randomized Controlled Trail

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Pacific Fertility Center:

Primary Outcome Measures:
  • pregnancy [ Time Frame: week 10 of study ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • uterine blood flow [ Time Frame: final measurement in week 8 ] [ Designated as safety issue: No ]

Enrollment: 320
Study Start Date: August 2008
Estimated Study Completion Date: October 2010
Estimated Primary Completion Date: October 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: 1
IVF
 Procedure: IVF
one 4 week IVF cycle
II
treatment
 Procedure: acupuncture
16 treatments over 8 weeks

  Eligibility

Ages Eligible for Study:   21 Years to 42 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • females between 21 and 42 years old
  • primary or secondary infertility
  • no more than 2 previously failed IVF cycles
  • undergoing IVF
  • FSH < 11

Exclusion Criteria:

  • FSH > 11
  • using an egg donor
  • using PGD
  • using heparin or lovanox protocols
  • estradiol level less than 20 or over 80
  • taking herbal therapy
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00736411

Locations
United States, California
Pacific Fertility Center
San Francisco, California, United States, 94133
Sponsors and Collaborators
Pacific Fertility Center
Investigators
Study Director: Caylie J See, L.Ac. Pacific Fertility Center
  More Information

No publications provided

Responsible Party: Eldon Schriock, Pacific Fertility Center
ClinicalTrials.gov Identifier: NCT00736411     History of Changes
Other Study ID Numbers: 28.005-2
Study First Received: August 13, 2008
Last Updated: April 4, 2011
Health Authority: United States: Institutional Review Board

Keywords provided by Pacific Fertility Center:
infertility
IVF
acupuncture

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

ClinicalTrials.gov processed this record on May 16, 2013