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

Supervision of Pregnancy Resulting From In-vitro Fertilization Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT01608048
• Other study ID #: CZheng2012QN180
• Status: Not yet recruiting
• Phase: N/A
• First received: May 24, 2012
• Last updated: March 29, 2014
• Start date: May 2014
• Est. completion date: February 2017

Study information

• Verified date: November 2012
• Source: Huazhong University of Science and Technology
• Contact: Cui Hong Zheng, Doctor
• Phone: 86-27-83663275
• Email: 635342693[@]qq.com
• Is FDA regulated: No
• Health authority: China: Ethics Committee
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 384
• Est. completion date: February 2017
• Est. primary completion date: April 2016
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 40 Years

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Supervision of Pregnancy Resulting From In-vitro Fertilization

Intervention

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.

Locations

Country	Name	City	State
China	IVF center of Tongji Hospital,Tongji medical college,HUST	Wuhan	Hubei

Sponsors (2)

Lead Sponsor	Collaborator
Huazhong University of Science and Technology	Wuhan General Hospital of Guangzhou Military Command

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	clinical pregnancy rate (CPR)		1 year	No
Secondary	Live birth rate (LBR)		2 years	No