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

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. Identifier: NCT00317317
Recruitment Status : Unknown
Verified August 2009 by National Center for Complementary and Integrative Health (NCCIH).
Recruitment status was:  Active, not recruiting
First Posted : April 24, 2006
Last Update Posted : August 28, 2009
Information provided by:
National Center for Complementary and Integrative Health (NCCIH)

April 20, 2006
April 24, 2006
August 28, 2009
October 2005
November 2009   (Final data collection date for primary outcome measure)
Clinical pregnancy rate [ Time Frame: 6 to 8 weeks ]
Clinical pregnant rate
Complete list of historical versions of study NCT00317317 on Archive Site
  • Miscarriage rate [ Time Frame: one year ]
  • Take home baby rate [ Time Frame: one year ]
  • B-endorphin levels [ Time Frame: 2 weeks ]
  • Stress measurement [ Time Frame: 4 weeks ]
  • Miscarriage rate
  • Take home babe rate
  • B-endophine levels
  • Stress measurement
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The Effect of Acupuncture on Infertility With In-Vitro Fertilization (IVF) Patients
Acupuncture for Infertility Patients: The Effect on IVF
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.

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:

  1. 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.
  2. 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:

  1. To examine the feasibility of recruiting and retaining a sufficient number of patients for an adequate powered study,
  2. To identify issues related to the multicenter approach that could alter study endpoints,
  3. To examine the effect size of the treatment group as compared to the sham group,
  4. To examine whether acupuncture is a safe procedure for women undergoing IVF,
  5. To examine the effect of acupuncture on clinical IVF outcomes, and
  6. 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.

Phase 1
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
Procedure: Acupuncture
4 acupuncture treatments will be conducted during the IVF cycle. The 1st one is at the beginning of egg stimulation, the 2nd one is before the egg retrieval, the 3rd and 4th one are before and after the embryo transfer
Not Provided
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.

*   Includes publications given by the data provider as well as publications identified by Identifier (NCT Number) in Medline.
Unknown status
Same as current
November 2009
November 2009   (Final data collection date for primary outcome measure)

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
Sexes Eligible for Study: Female
21 Years and older   (Adult, Older Adult)
Contact information is only displayed when the study is recruiting subjects
United States
R21AT002651-01A1( U.S. NIH Grant/Contract )
Not Provided
Not Provided
Grant Zhang, Assistant Professor, University of Maryland School of Medicine
National Center for Complementary and Integrative Health (NCCIH)
Not Provided
Principal Investigator: Grant Zhang, Ph.D. Center For Integrative Medicine, University of Maryland
National Center for Complementary and Integrative Health (NCCIH)
August 2009

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP