The Effect of Acupuncture on Pregnancy Rates in Women Undergoing Embryo Transfer - Full Text View

Purpose

The present study is designed to test the hypothesis that acupuncture, before and after embryo transfer, significantly improves pregnancy rates, compared to embryo transfer with sham acupuncture and no acupuncture at all.

Condition	Intervention	Phase
Pregnancy	Procedure: Active acupuncture Procedure: Sham acupuncture	Phase IV

MedlinePlus related topics:

Acupuncture

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Placebo Control, Parallel Assignment, Efficacy Study

Official Title:	The Effect of Acupuncture on Pregnancy Rates in Women Undergoing Embryo Transfer After in Vitro Fertilization: A Prospective Randomized Sham-Controlled Trial

Further study details as provided by Ottawa Fertility Centre:

Primary Outcome Measures:

Clinical Pregnancy [ Time Frame: 4-5 weeks after treatment ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Live birth [ Time Frame: 9 months after treatment ] [ Designated as safety issue: No ]
Implantation rate [ Time Frame: 4-5 weeks after treatment ] [ Designated as safety issue: No ]
Side effects with acupuncture treatment [ Time Frame: 2 weeks after treatment ] [ Designated as safety issue: Yes ]

Estimated Enrollment:	580
Study Start Date:	August 2008
Estimated Primary Completion Date:	August 2011 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Experimental Active acupuncture	Procedure: Active acupuncture Acupuncture 25 minutes before and after embryo transfer
2: Sham Comparator Sham Acupuncture- acupuncture at neutral points	Procedure: Sham acupuncture Acupuncture at neutral points, 25 minutes before and after embryo transfer
3: No Intervention Embryo transfer with no acupuncture

Eligibility

Genders Eligible for Study:	Female
Accepts Healthy Volunteers:	Yes

Criteria

Inclusion Criteria:

patient is undergoing embryo transfer after IVF or ICSI
patient has given informed consent to participate

Exclusion Criteria:

frozen embryo transfer
previous enrollment in study

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00722462

Contacts


Contact: Doron Shmorgun, MD	613-686-3378	dshmorgun@conceive.ca

Contact: Arthur Leader, MD	613-686-3378	aleader@conceive.ca

Locations


Canada, Ontario
	Ottawa Fertility Centre	Recruiting
	Ottawa, Ontario, Canada, K2C 3V4
	Contact: Doron Shmorgun, MD 613-686-3378 dshmorgun@conceive.ca
	Contact: Arthur Leader, MD 613-686-3378 aleader@conceive.ca
	Principal Investigator: Doron Shmorgun, MD
	Sub-Investigator: Arthur Leader, MD

Sponsors and Collaborators

Ottawa Fertility Centre

Investigators


Study Chair:	Arthur Leader, MD	Ottawa Fertility Centre

Principal Investigator:	Doron Shmorgun, MD	Ottawa Fertility Centre

More Information

Responsible Party:	Ottawa Fertility Centre ( Dr. Doron Shmorgun )
Study ID Numbers:	OttawaFC
First Received:	July 23, 2008
Last Updated:	October 22, 2008
ClinicalTrials.gov Identifier:	NCT00722462
Health Authority:	Canada: Health Canada; Canada: Canadian Institutes of Health Research

Keywords provided by Ottawa Fertility Centre:

Infertility

IVF

Acupuncture

Study placed in the following topic categories:

Infertility

ClinicalTrials.gov processed this record on October 24, 2008

Sponsored by:	Ottawa Fertility Centre
Information provided by:	Ottawa Fertility Centre
ClinicalTrials.gov Identifier:	NCT00722462