NCT01608048UnknownNot Applicable
Transcutaneous Electrical Acupoint Stimulation to Improve Pregnancy Rates for Women Undergoing in Vitro Fertilization
Huazhong University of Science and Technology1 site in 1 country384 target enrollmentStarted: May 1, 2014Last updated:
Conditions
Interventions
Trial Snapshot
- Phase
- Not Applicable
- Enrollment
- 384
- Locations
- 1
- Primary Endpoint
- clinical pregnancy rate (CPR)
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Single (Outcomes Assessor)
Eligibility Criteria
- Ages
- 18 Years to 40 Years (Adult)
- Sex
- Female
- Accepts Healthy Volunteers
- No
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.
Arms & Interventions
EA:electro-acupuncture
Experimental
Intervention: transcutaneous electrical acupoint stimulation (TEAS);EA (Device)
TEAS
Experimental
Intervention: transcutaneous electrical acupoint stimulation (TEAS);EA (Device)
control
No Intervention
Outcomes
Primary Outcomes
clinical pregnancy rate (CPR)
Time Frame: 1 year
Secondary Outcomes
- Live birth rate (LBR)(2 years)
Investigators
Cui Hong Zheng
assistant research fellow
Huazhong University of Science and Technology
Study Sites (1)
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