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Electro-acupuncture and Assisted Reproductive Technology

Primary Purpose

Infertility

Status
Terminated
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Acupuncture, Electro-Acupuncture
Sponsored by
National University of Health Sciences
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Infertility focused on measuring Infertility, acupuncture, frozen embryos, endometrium, TCM

Eligibility Criteria

21 Years - 45 Years (Adult)FemaleDoes not accept healthy volunteers

Inclusion Criteria:

  • Women undergoing medicated frozen embryo transfer uterine preparation
  • Ages between 21-45 years old
  • Must be fluent in English
  • Must be willing to receive four electro-acupuncture treatments
  • Must be willing to provide access to medical records from the fertility clinic

Exclusion Criteria:

  • Males
  • Subjects involved with fresh IVF cycle
  • Subjects with pace maker
  • Subjects with history of seizure disorders
  • All others who do not meet the inclusion criteria

Sites / Locations

  • Tiffani Kim Institute
  • National University of Health Sciences

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

No Intervention

Arm Label

Electro-Acupuncture

Control

Arm Description

Group will receive 4 acupuncture treatments over 14 days during hormone treatment

Group will not receive acupuncture.

Outcomes

Primary Outcome Measures

Change in endometrium thickness during hormone treatment
As part of the preparation for embryo transfer, patients undergo ultrasound during hormone treatment to assess endometrium thickness. Research participants will agree to release ultrasound results to the research personnel to determine whether acupuncture treatments affect endometrium thickness compared to no acupuncture treatment.

Secondary Outcome Measures

Full Information

First Posted
November 22, 2011
Last Updated
April 14, 2015
Sponsor
National University of Health Sciences
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1. Study Identification

Unique Protocol Identification Number
NCT01481090
Brief Title
Electro-acupuncture and Assisted Reproductive Technology
Official Title
Electro-acupuncture and Assisted Reproductive Technology: Impact of EA on Endometrium During Medicated Frozen Embryo Transfer Uterine Preparation
Study Type
Interventional

2. Study Status

Record Verification Date
April 2015
Overall Recruitment Status
Terminated
Why Stopped
IRB violations
Study Start Date
November 2010 (undefined)
Primary Completion Date
March 2012 (Actual)
Study Completion Date
March 2012 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
National University of Health Sciences

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
One of the most widely used procedures in reproductive medicine technologies is In Vitro Fertilization (IVF). During the IVF procedure, there are sometimes unused embryos that are frozen to be used at later times. If these embryos are thawed and transferred back to the mother, proper development of the uterine lining plays an important role in outcome of pregnancy. Electro-acupuncture (EA), a technique where electrical current is applied to the needle to stimulate an acupoint, has been shown to increase uterine blood flow, increasing the likelihood of developing a more ideal endometrial lining. This randomized study aims to evaluate the impact of EA on endometrium undergoing medicated frozen embryo transfer cycle preparation. The treatment group will receive four acupuncture treatments during the medicated uterine preparation. Endometrial thickness will be compared to a group that does not receive acupuncture.
Detailed Description
All the subjects in the study will be randomized and their participation is completely voluntary. Patients recruited to join the study will not receive any monetary compensation for participation. This research will include 100 female subjects, ages 21-45, undergoing medicated frozen embryo transfer (mFET). The subjects will be randomized into treatment and the non-treatment groups. The non-treatment group will undergo the medicated uterine preparation for FET according to the fertility clinic's protocol. Subjects in the treatment group will receive four electro-acupuncture (EA) treatments in addition to the mFET protocol, starting after the 1st Ultrasound measurement which constitutes as a baseline, until the start of the progesterone administration. Endometrial thickness will be measured using ultrasound and estrogen (E2) levels will be measured by blood samples as a standard measure to assess the time of P4 (progesterone) supplementation. This step will be done by the participant's fertility clinic according to the clinic's protocol. Acupuncture points of LI-4, LV-3, SP-6, Zi Gong, CV-3, CV-4, ST-36 will be needled. Electro-stimulation will be applied to acupoints SP-6, Zi-Gong, CV-3 and CV-4 at low frequency. The needle retention with electro-stimulation will last for 25 minutes. After the 25 minutes, the needles and the electro-stimulation will be removed and the patients will be dismissed. Ultrasound results measuring endometrium will be obtained from the subject's fertility clinic. US and bloodwork will be performed at baseline, and before the progesterone administration according to the fertility clinic. This US measurement and bloodwork results will be used for statistical analysis to compare endometrial lining of the two groups. The final discussion will be presented according to the findings.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Infertility
Keywords
Infertility, acupuncture, frozen embryos, endometrium, TCM

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
16 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Electro-Acupuncture
Arm Type
Active Comparator
Arm Description
Group will receive 4 acupuncture treatments over 14 days during hormone treatment
Arm Title
Control
Arm Type
No Intervention
Arm Description
Group will not receive acupuncture.
Intervention Type
Procedure
Intervention Name(s)
Acupuncture, Electro-Acupuncture
Intervention Description
Participants will receive 4 Electro-acupuncture stimulation applied to acupoints SP-6, Zi-Gong, CV-3 and CV-4acupuncture treatments during hormone treatment.
Primary Outcome Measure Information:
Title
Change in endometrium thickness during hormone treatment
Description
As part of the preparation for embryo transfer, patients undergo ultrasound during hormone treatment to assess endometrium thickness. Research participants will agree to release ultrasound results to the research personnel to determine whether acupuncture treatments affect endometrium thickness compared to no acupuncture treatment.
Time Frame
Baseline, day 8 and day 15 of hormone treatment

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
21 Years
Maximum Age & Unit of Time
45 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Women undergoing medicated frozen embryo transfer uterine preparation Ages between 21-45 years old Must be fluent in English Must be willing to receive four electro-acupuncture treatments Must be willing to provide access to medical records from the fertility clinic Exclusion Criteria: Males Subjects involved with fresh IVF cycle Subjects with pace maker Subjects with history of seizure disorders All others who do not meet the inclusion criteria
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Hui Y Cai, Ph.D
Organizational Affiliation
National University of Health Sciences
Official's Role
Principal Investigator
Facility Information:
Facility Name
Tiffani Kim Institute
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60654
Country
United States
Facility Name
National University of Health Sciences
City
Lombard
State/Province
Illinois
ZIP/Postal Code
60148
Country
United States

12. IPD Sharing Statement

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Electro-acupuncture and Assisted Reproductive Technology

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