Electro-acupuncture and Assisted Reproductive Technology

NCT01481090 | Terminated DMC

• 1 other identifier: NUHS H1007
• Study Type: interventional
• Target: 16
• Locations: 1 country
• Sites: 2

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.

Conditions

Infertility

Keywords

Infertility; acupuncture; frozen embryos; endometrium; TCM

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (2)

Electro-Acupuncture

ACTIVE COMPARATOR

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

Procedure: Acupuncture, Electro-Acupuncture

Control

NO INTERVENTION

Group will not receive acupuncture.

Interventions

Acupuncture, Electro-Acupuncture PROCEDURE

Participants will receive 4 Electro-acupuncture stimulation applied to acupoints SP-6, Zi-Gong, CV-3 and CV-4acupuncture treatments during hormone treatment.

Electro-Acupuncture

Eligibility Criteria

• Age: 21 Years - 45 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• Males
• Subjects involved with fresh IVF cycle
• Subjects with pace maker
• Subjects with history of seizure disorders

Sponsors & Collaborators

• National University of Health Sciences: lead

Study Sites (2)

Tiffani Kim Institute

Chicago, Illinois, 60654, United States

Location

National University of Health Sciences

Lombard, Illinois, 60148, United States

Location

MeSH Terms

Conditions

Infertility

Interventions

Acupuncture Therapy

Condition Hierarchy (Ancestors)

Genital Diseases; Urogenital Diseases

Intervention Hierarchy (Ancestors)

Complementary Therapies; Therapeutics

Study Officials

• Hui Y Cai, Ph.D

  National University of Health Sciences

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 22, 2011
• First Posted: November 29, 2011
• Study Start: November 1, 2010
• Primary Completion: March 1, 2012
• Study Completion: March 1, 2012
• Last Updated: April 15, 2015

Record last verified: 2015-04

Locations

US (2)