NCT00894946

Brief Summary

The hypothesis of this study is that Lipiodol uterine bathing improves the success rate of in vitro fertilization (IVF) for women with endometriosis or recurrent IVF implantation failure.

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
350

participants targeted

Target at P50-P75 for phase_3

Timeline
Completed

Started May 2009

Longer than P75 for phase_3

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

Study Start

First participant enrolled

May 1, 2009

Completed
5 days until next milestone

First Submitted

Initial submission to the registry

May 6, 2009

Completed
1 day until next milestone

First Posted

Study publicly available on registry

May 7, 2009

Completed
5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2014

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2014

Completed
Last Updated

May 7, 2009

Status Verified

May 1, 2009

Enrollment Period

5 years

First QC Date

May 6, 2009

Last Update Submit

May 6, 2009

Conditions

EndometriosisIn Vitro Fertilization Implantation Failure

Keywords

recurrent IVF implantation failure

Outcome Measures

Primary Outcomes (1)

  • Live birth

    12 months post-randomization

Secondary Outcomes (2)

  • Clinical pregnancy

    3 months post-randomization

  • Adverse events

    3 & 12 months post-randomization

Study Arms (2)

Recurrent IVF implantation failure

EXPERIMENTAL
Procedure: Lipiodol + IVFProcedure: IVF

Endometriosis

EXPERIMENTAL
Procedure: Lipiodol + IVFProcedure: IVF

Interventions

Lipiodol + IVFPROCEDURE

IVF preceded by lipiodol

EndometriosisRecurrent IVF implantation failure
IVFPROCEDURE

IVF alone

EndometriosisRecurrent IVF implantation failure

Eligibility Criteria

Age18 Years - 39 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • or more months infertility
  • Age 18 to 39
  • Endometriosis or recurrent IVF implantation failure
  • Patent fallopian tubes

You may not qualify if:

  • Iodine allergy
  • Blocked fallopian tube or tubes

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Auckland

Auckland, New Zealand

RECRUITING

MeSH Terms

Conditions

Endometriosis

Interventions

Ethiodized Oil

Condition Hierarchy (Ancestors)

Genital Diseases, FemaleFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesGenital Diseases

Intervention Hierarchy (Ancestors)

Iodized OilPlant OilsOilsLipidsPlant PreparationsBiological ProductsComplex Mixtures

Study Officials

  • Neil Johnson, MD

    University of Auckland, New Zealand

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Neil Johnson, MD

CONTACT

+64 274360172n.johnson@auckland.ac.nz

Shelley Reilly, MRANZCOG

CONTACT

sreilly@adhb.govt.nz

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

May 6, 2009

First Posted

May 7, 2009

Study Start

May 1, 2009

Primary Completion

May 1, 2014

Study Completion

May 1, 2014

Last Updated

May 7, 2009

Record last verified: 2009-05

Locations

NZ(1)