Transcutaneous Electrical Acupoint Stimulation to Improve Pregnancy Rates for Women Undergoing in Vitro Fertilization

March 29, 2014 updated by: Cui Hong Zheng, Huazhong University of Science and Technology
The objective of this study is to investigate the effect of transcutaneous electrical acupoint stimulation on pregnancy rates in women undergoing in vitro fertilization.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

384

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
    • Hubei
      • Wuhan, Hubei, China, 430030
        • IVF center of Tongji Hospital,Tongji medical college,HUST

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 40 years (ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

Inclusion Criteria:

(1) infertile women < 40 years of age, undergoing a fresh IVF or intracytoplasmic sperm injection (ICSI) cycle; (2) be an appropriate candidate with the potential for a lower success rate which defined as two or more previous unsuccessful ETs (fresh or frozen); (3) are willing to sign an informed consent form, indicating that they are aware of the investigational nature of this study that is in keeping with the policies of the institution; (4) willing to return to the study site for their study visits. The reason for our inclusion criteria is that women experienced several unsuccessful OAs or ETs may easily accept randomization to this study, and for whom adding TEAS or EA may significantly improve their clinical outcomes.

Exclusion Criteria:

(1) major medical illnesses (like stage III heart disease, severe hypertension, uncontrolled diabetes mellitus, HIV positivity, severe bleeding dyscrasias, etc.) possibly precluding IVF or pregnancy; (2) FSH more than 20 IU/L; (3) receiving donor eggs; (4) cutaneous lesion of certain acupoint area; (5) having been previously participated in this study or having undertaken acupuncture (in whatever modality) treatment for infertility.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: SINGLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
NO_INTERVENTION: control
EXPERIMENTAL: TEAS
Device: transcutaneous electrical acupoint stimulation (TEAS);EA
TEAS group (conventional IVF + TEAS), electro-acupuncture (EA) group (conventional IVF + electro-Acu.), and control group (only conventional IVF) Parameter of TEAS or EA: frequency of 2/100 Hz；moderate electrical current. Treatments start from the day 3 of menstruation，once every two days, 30 min for each for two continuous weeks.
EXPERIMENTAL: EA:electro-acupuncture
Device: transcutaneous electrical acupoint stimulation (TEAS);EA
TEAS group (conventional IVF + TEAS), electro-acupuncture (EA) group (conventional IVF + electro-Acu.), and control group (only conventional IVF) Parameter of TEAS or EA: frequency of 2/100 Hz；moderate electrical current. Treatments start from the day 3 of menstruation，once every two days, 30 min for each for two continuous weeks.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
clinical pregnancy rate (CPR)
Time Frame: 1 year
1 year

Secondary Outcome Measures

Outcome Measure
Time Frame
Live birth rate (LBR)
Time Frame: 2 years
2 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Huazhong University of Science and Technology

Collaborators

Wuhan General Hospital of Guangzhou Military Command

Investigators

  • Principal Investigator: Cui Hong Zheng, Doctor, Huazhong University of Science and Technology

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

May 1, 2014

Primary Completion (ANTICIPATED)

April 1, 2016

Study Completion (ANTICIPATED)

February 1, 2017

Study Registration Dates

First Submitted

May 24, 2012

First Submitted That Met QC Criteria

May 29, 2012

First Posted (ESTIMATE)

May 30, 2012

Study Record Updates

Last Update Posted (ESTIMATE)

April 1, 2014

Last Update Submitted That Met QC Criteria

March 29, 2014

Last Verified

November 1, 2012

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • CZheng2012QN180

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Supervision of Pregnancy Resulting From In-vitro Fertilization

Clinical Trials on transcutaneous electrical acupoint stimulation (TEAS);EA

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in United Kingdom

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe