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.|
|ClinicalTrials.gov 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
|Condition or disease||Intervention/treatment||Phase|
|Infertility||Procedure: Acupuncture||Phase 1|
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.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||60 participants|
|Intervention Model:||Parallel Assignment|
|Official Title:||Acupuncture for Infertility Patients: The Effect on IVF|
|Study Start Date :||October 2005|
|Estimated Primary Completion Date :||November 2009|
|Estimated Study Completion Date :||November 2009|
- Clinical pregnancy rate [ Time Frame: 6 to 8 weeks ]
- 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 ]
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00317317
|United States, Maryland|
|Reproductive Endocrinology and Infertility, Dept. of OB/GYN|
|Baltimore, Maryland, United States, 21201|
|The GBMC Fertility Center|
|Baltimore, Maryland, United States, 21204|
|Principal Investigator:||Grant Zhang, Ph.D.||Center For Integrative Medicine, University of Maryland|