The Effect of Acupuncture on Pregnancy Rates in Women Und... | NCT00722462

Studies
The Effect of Acupuncture on Pregnancy Rates in Women Undergoing Embryo Transfer

NCT00722462

Sponsor

Ottawa Fertility Centre

Status

Terminated

Last Update Posted

Jul 9, 2015Estimated

Enrollment

30Actual

Phase

Phase 4

Conditions

Pregnancy

Interventions

Active acupuncture
Sham acupuncture

Countries

Canada

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jul 2015

Overall Recruitment Status or Expanded Access Status

Terminated

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Recent abstract publication questioning the need for our study

Expanded Access Info

Start Date

Aug 2008

Primary Completion Date

May 2009Actual

Completion Date

May 2009Actual

First Submitted Date

Jul 23, 2008

First Submission Date that Met QC Criteria

Jul 24, 2008

First Posted Date

Jul 25, 2008Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jul 7, 2015

Last Update Posted Date

Jul 9, 2015Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

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.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 4

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

30Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
1	Experimental	Active acupuncture	Procedure: Active acupuncture
2	Sham Comparator	Sham Acupuncture- acupuncture at neutral points	Procedure: Sham acupuncture
3	No Intervention	Embryo transfer with no acupuncture

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Active acupuncture	Procedure	Acupuncture 25 minutes before and after embryo transfer	1

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Clinical Pregnancy		4-5 weeks after treatment

Secondary Outcomes

Measure	Description	Time Frame
Live birth		9 months after treatment
Implantation rate		4-5 weeks after treatment
Side effects with acupuncture treatment

Other Outcomes

Not provided

Eligibility Module

Eligibility 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

Accepts Healthy Volunteers

Yes

Sex

Female

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

Not provided

Maximum Age

Not provided

Standard Ages

ChildAdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Arthur Leader, MD	Ottawa Fertility Centre	Study Chair
Doron Shmorgun, MD	Ottawa Fertility Centre	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Ottawa Fertility Centre		Ottawa	Ontario	K2C 3V4	Canada

Condition Browse Module

MeSH Terms

ID	Term
D007246	Infertility

Ancestor Terms

ID	Term
D000091662	Genital Diseases
D000091642	Urogenital Diseases

Browse Leaves

Not provided

Browse Branches

Not provided