NCT00722462

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.

Trial Health

57
Monitor

Trial Health Score

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

Enrollment
30

participants targeted

Target at below P25 for phase_4 pregnancy

Timeline
Completed

Started Aug 2008

Shorter than P25 for phase_4 pregnancy

Geographic Reach
1 country

1 active site

Status
terminated

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

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

July 23, 2008

Completed
2 days until next milestone

First Posted

Study publicly available on registry

July 25, 2008

Completed
7 days until next milestone

Study Start

First participant enrolled

August 1, 2008

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2009

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2009

Completed
Last Updated

July 9, 2015

Status Verified

July 1, 2015

Enrollment Period

9 months

First QC Date

July 23, 2008

Last Update Submit

July 7, 2015

Conditions

Pregnancy

Keywords

InfertilityIVFAcupuncture

Outcome Measures

Primary Outcomes (1)

  • Clinical Pregnancy

    4-5 weeks after treatment

Secondary Outcomes (3)

  • Live birth

    9 months after treatment

  • Implantation rate

    4-5 weeks after treatment

  • Side effects with acupuncture treatment

    2 weeks after treatment

Study Arms (3)

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

Active acupuncturePROCEDURE

Acupuncture 25 minutes before and after embryo transfer

1
Sham acupuncturePROCEDURE

Acupuncture at neutral points, 25 minutes before and after embryo transfer

2

Eligibility Criteria

Sexfemale
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • frozen embryo transfer
  • previous enrollment in study

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Ottawa Fertility Centre

Ottawa, Ontario, K2C 3V4, Canada

Location

MeSH Terms

Conditions

Infertility

Condition Hierarchy (Ancestors)

Genital DiseasesUrogenital Diseases

Study Officials

  • Arthur Leader, MD

    Ottawa Fertility Centre

    STUDY CHAIR

  • Doron Shmorgun, MD

    Ottawa Fertility Centre

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 23, 2008

First Posted

July 25, 2008

Study Start

August 1, 2008

Primary Completion

May 1, 2009

Study Completion

May 1, 2009

Last Updated

July 9, 2015

Record last verified: 2015-07

Locations

CA(1)