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

Study Description

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Brief Summary:

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 or disease	Intervention/treatment	Phase
Infertility	Procedure: Acupuncture	Phase 1

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:

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.

Study Design

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Study Type :	Interventional (Clinical Trial)
Estimated Enrollment :	60 participants
Allocation:	Randomized
Intervention Model:	Parallel Assignment
Masking:	Single (Participant)
Primary Purpose:	Treatment
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

Arms and Interventions

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Intervention Details:

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

Outcome Measures

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Primary Outcome Measures :

1. Clinical pregnancy rate [ Time Frame: 6 to 8 weeks ]

Secondary Outcome Measures :

1. Miscarriage rate [ Time Frame: one year ]
2. Take home baby rate [ Time Frame: one year ]
3. B-endorphin levels [ Time Frame: 2 weeks ]
4. Stress measurement [ Time Frame: 4 weeks ]

Eligibility Criteria

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Ages Eligible for Study:	21 Years and older (Adult, Senior)
Sexes 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

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Locations

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

Sponsors and Collaborators

National Center for Complementary and Integrative Health (NCCIH)

Investigators

Principal Investigator:	Grant Zhang, Ph.D.	Center For Integrative Medicine, University of Maryland

More Information

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations 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.

Responsible Party:	Grant Zhang, Assistant Professor, University of Maryland School of Medicine
ClinicalTrials.gov Identifier:	NCT00317317 History of Changes
Other Study ID Numbers:	R21AT002651-01A1 ( U.S. NIH Grant/Contract )
First Posted:	April 24, 2006
Last Update Posted:	August 28, 2009
Last Verified:	August 2009

Keywords provided by National Center for Complementary and Integrative Health (NCCIH):

IVF; Acupuncture; Pregnant

Additional relevant MeSH terms:

Infertility; Genital Diseases, Male; Genital Diseases, Female