Electro-acupuncture and Assisted Reproductive Technology

Electro-acupuncture and Assisted Reproductive Technology: Impact of EA on Endometrium During Medicated Frozen Embryo Transfer Uterine Preparation

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.

Study Overview

• Status: Terminated
• Conditions: Infertility
• Intervention / Treatment: Procedure: Acupuncture, Electro-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.

• Study Type: Interventional
• Enrollment (Actual): 16
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Illinois
    • Chicago, Illinois, United States, 60654
      • Tiffani Kim Institute
    • Lombard, Illinois, United States, 60148
      • National University of Health Sciences

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 21 years to 45 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	Baseline, day 8 and day 15 of hormone treatment

Collaborators and Investigators

• Sponsor: National University of Health Sciences
• Investigators: Principal Investigator: Hui Y Cai, Ph.D, National University of Health Sciences

Study record dates

Study Major Dates

• Study Start: November 1, 2010
• Primary Completion (Actual): March 1, 2012
• Study Completion (Actual): March 1, 2012

Study Registration Dates

• First Submitted: November 22, 2011
• First Submitted That Met QC Criteria: November 23, 2011
• First Posted (Estimate): November 29, 2011

Study Record Updates

• Last Update Posted (Estimate): April 15, 2015
• Last Update Submitted That Met QC Criteria: April 14, 2015
• Last Verified: April 1, 2015

More Information

Terms related to this study

• Keywords: Infertility; acupuncture; endometrium; TCM; frozen embryos
• Additional Relevant MeSH Terms: Infertility
• Other Study ID Numbers: NUHS H1007