Overview

This trial is active, not recruiting.

Condition infertility
Treatment acupuncture
Phase phase 1
Sponsor National Center for Complementary and Alternative Medicine (NCCAM)
Start date October 2005
End date November 2009
Trial size 60 participants
Trial identifier NCT00317317, R21 AT002651-01A1

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification safety/efficacy study
Intervention model parallel assignment
Masking single blind (subject)
Primary purpose treatment

Primary Outcomes

Measure
Clinical pregnancy rate
time frame: 6 to 8 weeks

Secondary Outcomes

Measure
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

Eligibility Criteria

Female participants at least 21 years old.

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

Additional Information

Official title Acupuncture for Infertility Patients: The Effect on IVF
Principal investigator Grant Zhang, Ph.D.
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.
Trial information was received from ClinicalTrials.gov and was last updated in August 2009.
Information provided to ClinicalTrials.gov by National Center for Complementary and Alternative Medicine (NCCAM).