NCT01608048

Brief 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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
384

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started May 2014

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

May 24, 2012

Completed
6 days until next milestone

First Posted

Study publicly available on registry

May 30, 2012

Completed
1.9 years until next milestone

Study Start

First participant enrolled

May 1, 2014

Completed
1.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2016

Completed
10 months until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2017

Completed
Last Updated

April 1, 2014

Status Verified

November 1, 2012

Enrollment Period

1.9 years

First QC Date

May 24, 2012

Last Update Submit

March 29, 2014

Conditions

Keywords

In-vitro Fertilizationtranscutaneous electrical acupoint stimulation

Outcome Measures

Primary Outcomes (1)

  • clinical pregnancy rate (CPR)

    1 year

Secondary Outcomes (1)

  • Live birth rate (LBR)

    2 years

Study Arms (3)

control

NO INTERVENTION

TEAS

EXPERIMENTAL
Device: transcutaneous electrical acupoint stimulation (TEAS);EA

EA:electro-acupuncture

EXPERIMENTAL
Device: transcutaneous electrical acupoint stimulation (TEAS);EA

Interventions

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.

EA:electro-acupunctureTEAS

Eligibility Criteria

Age18 Years - 40 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may not qualify if:

  • (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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

IVF center of Tongji Hospital,Tongji medical college,HUST

Wuhan, Hubei, 430030, China

Location

Related Publications (1)

  • Zheng CH, Zhang J, Wu J, Zhang MM. The effect of transcutaneous electrical acupoint stimulation on pregnancy rates in women undergoing in vitro fertilization: a study protocol for a randomized controlled trial. Trials. 2014 May 9;15:162. doi: 10.1186/1745-6215-15-162.

Study Officials

  • Cui Hong Zheng, Doctor

    Huazhong University of Science and Technology

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Cui Hong Zheng, Doctor

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
assistant research fellow

Study Record Dates

First Submitted

May 24, 2012

First Posted

May 30, 2012

Study Start

May 1, 2014

Primary Completion

April 1, 2016

Study Completion

February 1, 2017

Last Updated

April 1, 2014

Record last verified: 2012-11

Locations