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

This study is not yet open for participant recruitment. (see Contacts and Locations)
Verified November 2012 by Huazhong University of Science and Technology
Sponsor:
Collaborator:
Wuhan General Hospital of Guangzhou Military Command
Information provided by (Responsible Party):
Cui Hong Zheng, Huazhong University of Science and Technology
ClinicalTrials.gov Identifier:
NCT01608048
First received: May 24, 2012
Last updated: March 29, 2014
Last verified: November 2012
  Purpose

The objective of this study is to investigate the effect of transcutaneous electrical acupoint stimulation on pregnancy rates in women undergoing in vitro fertilization.


Condition Intervention
Supervision of Pregnancy Resulting From In-vitro Fertilization
Device: transcutaneous electrical acupoint stimulation (TEAS);EA

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Transcutaneous Electrical Acupoint Stimulation to Improve Pregnancy Rates for Women Undergoing in Vitro Fertilization

Resource links provided by NLM:


Further study details as provided by Huazhong University of Science and Technology:

Primary Outcome Measures:
  • clinical pregnancy rate (CPR) [ Time Frame: 1 year ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Live birth rate (LBR) [ Time Frame: 2 years ] [ Designated as safety issue: No ]

Estimated Enrollment: 384
Study Start Date: May 2014
Estimated Study Completion Date: February 2017
Estimated Primary Completion Date: April 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

  Eligibility

Ages Eligible for Study:   18 Years to 40 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

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.

  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: NCT01608048

Contacts
Contact: Cui Hong Zheng, Doctor 86-27-83663275 635342693@qq.com

Locations
China, Hubei
IVF center of Tongji Hospital,Tongji medical college,HUST Recruiting
Wuhan, Hubei, China, 430030
Principal Investigator: Cui Hong Zheng, Doctor         
Sponsors and Collaborators
Huazhong University of Science and Technology
Wuhan General Hospital of Guangzhou Military Command
Investigators
Principal Investigator: Cui Hong Zheng, Doctor Huazhong University of Science and Technology
  More Information

No publications provided by Huazhong University of Science and Technology

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Cui Hong Zheng, assistant research fellow, Huazhong University of Science and Technology
ClinicalTrials.gov Identifier: NCT01608048     History of Changes
Other Study ID Numbers: CZheng2012QN180
Study First Received: May 24, 2012
Last Updated: March 29, 2014
Health Authority: China: Ethics Committee

Keywords provided by Huazhong University of Science and Technology:
In-vitro Fertilization
transcutaneous electrical acupoint stimulation

ClinicalTrials.gov processed this record on September 18, 2014