Clinical trial NCT00317317: The Effect of Acupuncture on Infertility With In-Vitro Fertilization (IVF) Patients
Official title: Acupuncture for Infertility Patients: The Effect on IVF
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Infertility
Keywords: IVF
Acupuncture
Pregnant
Lead sponsor: National Center for Complementary and Integrative Health (NCCIH)
Sponsor class: NIH
First posted: 2006-04-24
Enrollment: 60
Sex: FEMALE
Minimum age (years): 21
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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.

Eligibility 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

Primary outcomes:
measure: Clinical pregnancy rate
timeFrame: 6 to 8 weeks
Secondary outcomes:
measure: Miscarriage rate
timeFrame: one year
measure: Take home baby rate
timeFrame: one year
measure: B-endorphin levels
timeFrame: 2 weeks
measure: Stress measurement
timeFrame: 4 weeks
Other outcomes:
Locations:
city: Baltimore
country: United States
facility: Reproductive Endocrinology and Infertility, Dept. of OB/GYN
state: Maryland
city: Baltimore
country: United States
facility: The GBMC Fertility Center
state: Maryland
Study officials:
affiliation: Center For Integrative Medicine, University of Maryland
name: Grant Zhang, Ph.D.
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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. doi: 10.1016/s0015-0282(01)03273-3.