Back to resultsIn Vitro Fertilization (IVF) and Acupuncture for Infertility
Primary Purpose
Infertility
Status
Terminated
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
acupuncture
IVF
Sponsored by
About this trial
This is an interventional treatment trial for Infertility focused on measuring infertility, IVF, acupuncture
Eligibility Criteria
Inclusion Criteria:
- females between 21 and 42 years old
- primary or secondary infertility
- no more than 2 previously failed IVF cycles
- undergoing IVF
- FSH < 11
Exclusion Criteria:
- FSH > 11
- using an egg donor
- using PGD
- using heparin or lovanox protocols
- estradiol level less than 20 or over 80
- taking herbal therapy
Sites / Locations
- Pacific Fertility Center
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Other
Arm Label
1
II
Arm Description
IVF
treatment
Outcomes
Primary Outcome Measures
pregnancy
Secondary Outcome Measures
uterine blood flow
Full Information
NCT ID
NCT00736411
First Posted
August 13, 2008
Last Updated
October 27, 2015
Sponsor
Pacific Fertility Center
1. Study Identification
Unique Protocol Identification Number
NCT00736411
Brief Title
In Vitro Fertilization (IVF) and Acupuncture for Infertility
Official Title
IVF and Acupuncture for Infertility: A Randomized Controlled Trail
Study Type
Interventional
2. Study Status
Record Verification Date
October 2015
Overall Recruitment Status
Terminated
Why Stopped
Adjustments to ensure clear outcomes and scientific merit integrated. Study closed at 14 subjects. New protocol submitted to IRB.
Study Start Date
August 2008 (undefined)
Primary Completion Date
October 2010 (Actual)
Study Completion Date
October 2010 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Pacific Fertility Center
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
The aim of this investigation is to determine the value of combining acupuncture with infertility patients undergoing In Vitro Fertilization (IVF). The investigators will measure the outcomes of endometrial lining, uterine blood flow, hormones, stress levels, and pregnancy and live birth rates.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Infertility
Keywords
infertility, IVF, acupuncture
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
320 (Actual)
8. Arms, Groups, and Interventions
Arm Title
1
Arm Type
Active Comparator
Arm Description
IVF
Arm Title
II
Arm Type
Other
Arm Description
treatment
Intervention Type
Procedure
Intervention Name(s)
acupuncture
Intervention Description
16 treatments over 8 weeks
Intervention Type
Procedure
Intervention Name(s)
IVF
Intervention Description
one 4 week IVF cycle
Primary Outcome Measure Information:
Title
pregnancy
Time Frame
week 10 of study
Secondary Outcome Measure Information:
Title
uterine blood flow
Time Frame
final measurement in week 8
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
21 Years
Maximum Age & Unit of Time
42 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
females between 21 and 42 years old
primary or secondary infertility
no more than 2 previously failed IVF cycles
undergoing IVF
FSH < 11
Exclusion Criteria:
FSH > 11
using an egg donor
using PGD
using heparin or lovanox protocols
estradiol level less than 20 or over 80
taking herbal therapy
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Caylie J See, L.Ac.
Organizational Affiliation
Pacific Fertility Center
Official's Role
Study Director
Facility Information:
Facility Name
Pacific Fertility Center
City
San Francisco
State/Province
California
ZIP/Postal Code
94133
Country
United States
12. IPD Sharing Statement
Learn more about this trial
In Vitro Fertilization (IVF) and Acupuncture for Infertility
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