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

Primary Purpose

Infertility

Status
Completed
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
Acupuncture
Sponsored by
National Center for Complementary and Integrative Health (NCCIH)
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Infertility focused on measuring IVF, Acupuncture, Pregnant

Eligibility Criteria

21 Years - undefined (Adult, Older Adult)FemaleDoes not accept healthy volunteers

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

Sites / Locations

  • Reproductive Endocrinology and Infertility, Dept. of OB/GYN
  • The GBMC Fertility Center

Outcomes

Primary Outcome Measures

Clinical pregnancy rate

Secondary Outcome Measures

Miscarriage rate
Take home baby rate
B-endorphin levels
Stress measurement

Full Information

First Posted
April 20, 2006
Last Updated
September 10, 2019
Sponsor
National Center for Complementary and Integrative Health (NCCIH)
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1. Study Identification

Unique Protocol Identification Number
NCT00317317
Brief Title
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

2. Study Status

Record Verification Date
August 2009
Overall Recruitment Status
Completed
Study Start Date
October 2005 (undefined)
Primary Completion Date
February 2009 (Actual)
Study Completion Date
November 2009 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
National Center for Complementary and Integrative Health (NCCIH)

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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: 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Infertility
Keywords
IVF, Acupuncture, Pregnant

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
60 (Actual)

8. Arms, Groups, and Interventions

Intervention Type
Procedure
Intervention Name(s)
Acupuncture
Intervention Description
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
Primary Outcome Measure Information:
Title
Clinical pregnancy rate
Time Frame
6 to 8 weeks
Secondary Outcome Measure Information:
Title
Miscarriage rate
Time Frame
one year
Title
Take home baby rate
Time Frame
one year
Title
B-endorphin levels
Time Frame
2 weeks
Title
Stress measurement
Time Frame
4 weeks

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
21 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Grant Zhang, Ph.D.
Organizational Affiliation
Center For Integrative Medicine, University of Maryland
Official's Role
Principal Investigator
Facility Information:
Facility Name
Reproductive Endocrinology and Infertility, Dept. of OB/GYN
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21201
Country
United States
Facility Name
The GBMC Fertility Center
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21204
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
11937123
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.
Results Reference
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The Effect of Acupuncture on Infertility With In-Vitro Fertilization (IVF) Patients

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