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In Vitro Fertilization (IVF) and Acupuncture for Infertility

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: NCT00736411
Recruitment Status : Terminated (Adjustments to ensure clear outcomes and scientific merit integrated. Study closed at 14 subjects. New protocol submitted to IRB.)
First Posted : August 15, 2008
Last Update Posted : October 29, 2015
Sponsor:
Information provided by (Responsible Party):

Study Description
Brief Summary:
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 or disease Intervention/treatment
Infertility Procedure: acupuncture Procedure: IVF

Study Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 320 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: IVF and Acupuncture for Infertility: A Randomized Controlled Trail
Study Start Date : August 2008
Primary Completion Date : October 2010
Study Completion Date : October 2010

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
Active Comparator: 1
IVF
Procedure: IVF
one 4 week IVF cycle
II
treatment
Procedure: acupuncture
16 treatments over 8 weeks


Outcome Measures

Primary Outcome Measures :
  1. pregnancy [ Time Frame: week 10 of study ]

Secondary Outcome Measures :
  1. uterine blood flow [ Time Frame: final measurement in week 8 ]

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   21 Years to 42 Years   (Adult)
Sexes 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

Information from the National Library of Medicine

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): 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

Responsible Party: Pacific Fertility Center
ClinicalTrials.gov Identifier: NCT00736411     History of Changes
Other Study ID Numbers: 28.005-2
First Posted: August 15, 2008    Key Record Dates
Last Update Posted: October 29, 2015
Last Verified: October 2015

Keywords provided by Pacific Fertility Center:
infertility
IVF
acupuncture

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