Electro-acupuncture and Assisted Reproductive Technology

This study has been terminated.
(IRB violations)
Sponsor:
Information provided by (Responsible Party):
National University of Health Sciences
ClinicalTrials.gov Identifier:
NCT01481090
First received: November 22, 2011
Last updated: March 19, 2012
Last verified: March 2012
  Purpose

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.


Condition Intervention
Infertility
Procedure: Acupuncture, Electro-Acupuncture
Other: Control

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Electro-acupuncture and Assisted Reproductive Technology: Impact of EA on Endometrium During Medicated Frozen Embryo Transfer Uterine Preparation

Resource links provided by NLM:


Further study details as provided by National University of Health Sciences:

Primary Outcome Measures:
  • Change in endometrium thickness during hormone treatment [ Time Frame: Baseline, day 8 and day 15 of hormone treatment ] [ Designated as safety issue: No ]
    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.


Enrollment: 16
Study Start Date: November 2010
Estimated Study Completion Date: November 2012
Estimated Primary Completion Date: November 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Electro-Acupuncture
Group will receive 4 acupuncture treatments over 14 days during hormone treatment
Procedure: Acupuncture, Electro-Acupuncture
Participants will receive 4 Electro-acupuncture stimulation applied to acupoints SP-6, Zi-Gong, CV-3 and CV-4acupuncture treatments during hormone treatment.
No Intervention: Control
Group will not receive acupuncture.
Other: Control
participants will 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.

  Eligibility

Ages Eligible for Study:   21 Years to 45 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01481090

Locations
United States, Illinois
Tiffani Kim Institute
Chicago, Illinois, United States, 60654
National University of Health Sciences
Lombard, Illinois, United States, 60148
Sponsors and Collaborators
National University of Health Sciences
Investigators
Principal Investigator: Hui Y Cai, Ph.D National University of Health Sciences
  More Information

No publications provided

Responsible Party: National University of Health Sciences
ClinicalTrials.gov Identifier: NCT01481090     History of Changes
Other Study ID Numbers: NUHS H1007
Study First Received: November 22, 2011
Last Updated: March 19, 2012
Health Authority: United States: Institutional Review Board

Keywords provided by National University of Health Sciences:
Infertility
acupuncture
frozen embryos
endometrium
TCM

Additional relevant MeSH terms:
Infertility
Genital Diseases, Male
Genital Diseases, Female

ClinicalTrials.gov processed this record on September 22, 2014