The Effect of Acupuncture on Infertility With In-Vitro Fertilization (IVF) Patients - Full Text View

Sponsored by:	National Center for Complementary and Alternative Medicine (NCCAM)
Information provided by:	National Center for Complementary and Alternative Medicine (NCCAM)
ClinicalTrials.gov Identifier:	NCT00317317

Purpose

Infertility is a common problem with increased incidence. In-vitro fertilization (IVF) is by far the most commonly used treatment. The success rate of IVF is still low. This study examines the effect of acupuncture on IVF pregnancy rate, as well as possible mechanisms. It is hypothesized that acupuncture can significantly increase the IVF pregnancy rate.

Condition	Intervention	Phase
Infertility	Procedure: Acupuncture	Phase I

MedlinePlus related topics: Acupuncture Infertility

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Single Blind, Placebo Control, Parallel Assignment, Safety/Efficacy Study
Official Title:	Acupuncture for Infertility Patients: The Effect on IVF

Further study details as provided by National Center for Complementary and Alternative Medicine (NCCAM):

Primary Outcome Measures:

Clinical pregnancy rate

Secondary Outcome Measures:

Miscarriage rate
Take home baby rate
B-endorphin levels
Stress measurement

Estimated Enrollment:	60
Study Start Date:	October 2005
Estimated Study Completion Date:	August 2008

Detailed Description:

Infertility is a common health problem in the United States with approximately 15% of women of childbearing age receiving care for this disorder. One of the most successful and commonly utilized treatment options is in-vitro fertilization (IVF). Data collected by the Center for Disease Control (CDC) and the Society for Assisted Reproduction (SART) showed that in the year 2001, over 100,000 IVF treatment cycles were performed through the more than 400 IVF centers in the U.S. Despite many recent technological advances, pregnancy rates with IVF remain limited with the most recent CDC/SART data reporting that only 27% of treatment cycles result in a live birth. Acupuncture has been utilized in China for centuries to regulate the female reproductive system and has in recent years become a popular option for infertile couples in the States. Though acupuncture has been studied in other infertility settings, IVF is chosen because:

IVF is one of the most common infertility treatments as well as the most resource intensive treatment option. Therefore, an improvement in IVF success will provide the greatest benefit to patients and society.
IVF affords a unique opportunity to gather the most data regarding the reproductive process and to investigate putative acupuncture related physiological changes.

We propose a randomized, sham controlled feasibility study on the effect of acupuncture on IVF. Sixty IVF patients will be recruited into the study to accomplish the following aims:

To examine the feasibility of recruiting and retaining a sufficient number of patients for an adequate powered study,
To identify issues related to the multicenter approach that could alter study endpoints,
To examine the effect size of the treatment group as compared to the sham group,
To examine whether acupuncture is a safe procedure for women undergoing IVF,
To examine the effect of acupuncture on clinical IVF outcomes, and
To examine the physiological and psychological impact of acupuncture on IVF patients.

Results obtained from the study will provide necessary information for a larger, definitive study, as well as knowledge regarding the broad mechanism of acupuncture on female reproductive function.

Eligibility

Ages Eligible for Study:	21 Years and older
Genders Eligible for Study:	Female
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Patient is undergoing in-vitro fertilization protocol (both IVF and intracytoplasmic sperm injection - ICSI)
Patient is acupuncture naïve.
Patient has basal serum follicle-stimulating hormone (FSH) < 10
Patient has given informed consent to participate in study

Exclusion Criteria:

Patient has had acupuncture performed previously or currently
Patient has basal serum FSH of 10 or more

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00317317

Contacts

Contact: Laurence Udoff, MD	410-328-2304	ludoff@umm.edu
Contact: Sonya Leasure	410-328-2304	sleasure@umm.edu

Locations

United States, Maryland
Reproductive Endocrinology and Infertility, Dept. of OB/GYN	Recruiting
Baltimore, Maryland, United States, 21201
Sub-Investigator: Laurence Udoff, MD
The GBMC Fertility Center	Recruiting
Baltimore, Maryland, United States, 21204
Contact: Eugene Katz, MD 443-849-2484 EKATZ@gbmc.org
Contact: Sonja Leasure 410-328-2460 sleasure@umm.edu
Principal Investigator: Eugene Katz, MD

Sponsors and Collaborators

National Center for Complementary and Alternative Medicine (NCCAM)

Investigators

Principal Investigator:

Grant Zhang, Ph.D.

Center For Integrative Medicine, University of Maryland

More Information

Publications:

Paulus WE, Zhang M, Strehler E, El-Danasouri I, Sterzik K. Influence of acupuncture on the pregnancy rate in patients who undergo assisted reproduction therapy. Fertil Steril. 2002 Apr;77(4):721-4.

Study ID Numbers:	R21 AT002651-01A1
Study First Received:	April 20, 2006
Last Updated:	July 13, 2007
ClinicalTrials.gov Identifier:	NCT00317317
Health Authority:	United States: Federal Government

Keywords provided by National Center for Complementary and Alternative Medicine (NCCAM):

IVF
Acupuncture
Pregnant

Study placed in the following topic categories:

Genital Diseases, Female
Infertility
Genital Diseases, Male

ClinicalTrials.gov processed this record on January 16, 2009