The In Vitro Fertilization - Lipiodol Uterine Bathing Eff... | NCT00894946

Studies
The In Vitro Fertilization - Lipiodol Uterine Bathing Effect Study

NCT00894946

Sponsor

University of Auckland, New Zealand

Status

Unknown status

Last Update Posted

May 7, 2009Estimated

Enrollment

350Estimated

Phase

Phase 3

Conditions

Endometriosis
In Vitro Fertilization Implantation Failure

Interventions

Lipiodol + IVF
IVF

Countries

New Zealand

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

May 2009

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

May 2009

Primary Completion Date

May 2014Estimated

Completion Date

May 2014Estimated

First Submitted Date

May 6, 2009

First Submission Date that Met QC Criteria

May 6, 2009

First Posted Date

May 7, 2009Estimated

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

May 6, 2009

Last Update Posted Date

May 7, 2009Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

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 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.

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 3

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

350Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Recurrent IVF implantation failure	Experimental		Procedure: Lipiodol + IVF Procedure: IVF
Endometriosis	Experimental		Procedure: Lipiodol + IVF Procedure: IVF

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Lipiodol + IVF	Procedure	IVF preceded by lipiodol	Endometriosis Recurrent IVF implantation failure

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Live birth		12 months post-randomization

Secondary Outcomes

Measure	Description	Time Frame
Clinical pregnancy		3 months post-randomization
Adverse events		3 & 12 months post-randomization

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

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

Exclusion Criteria:

Iodine allergy
Blocked fallopian tube or tubes

Accepts Healthy Volunteers

Sex

Female

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

39 Years

Standard Ages

Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Neil Johnson, MD	Contact	+64 274360172		n.johnson@auckland.ac.nz
Shelley Reilly, MRANZCOG	Contact			sreilly@adhb.govt.nz

Overall Officials

Name	Affiliation	Role
Neil Johnson, MD	University of Auckland, New Zealand	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
University of Auckland	Recruiting	Auckland			New Zealand

Condition Browse Module

MeSH Terms

ID	Term
D004715	Endometriosis

Ancestor Terms

ID	Term
D005831	Genital Diseases, Female
D052776	Female Urogenital Diseases
D005261	Female Urogenital Diseases and Pregnancy Complications
D000091642	Urogenital Diseases

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D004998	Ethiodized Oil

Ancestor Terms

ID	Term
D007459	Iodized Oil
D010938	Plant Oils
D009821	Oils
D008055	Lipids
D028321

Browse Leaves

Not provided

Browse Branches

Not provided