The In Vitro Fertilization - Lipiodol Uterine Bathing Effect Study
The recruitment status of this study is unknown because the information has not been verified recently.
Verified May 2009 by University of Auckland, New Zealand.
Recruitment status was Recruiting
Recruitment status was Recruiting
Sponsor:
University of Auckland, New Zealand
Information provided by:
University of Auckland, New Zealand
ClinicalTrials.gov Identifier:
NCT00894946
First received: May 6, 2009
Last updated: NA
Last verified: May 2009
History: No changes posted
- Full Text View
- Tabular View
- No Study Results Posted
- Disclaimer
- How to Read a Study Record
Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Endometriosis In Vitro Fertilization Implantation Failure |
Procedure: Lipiodol + IVF Procedure: IVF |
Phase 3 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | The in Vitro Fertilisation - Lipiodol Uterine Bathing Effect Study |
Resource links provided by NLM:
MedlinePlus related topics:
Endometriosis
Drug Information available for:
Ethiodized oil
U.S. FDA Resources
Further study details as provided by University of Auckland, New Zealand:
Primary Outcome Measures:
- Live birth [ Time Frame: 12 months post-randomization ] [ Designated as safety issue: No ]
Secondary Outcome Measures:
- Clinical pregnancy [ Time Frame: 3 months post-randomization ] [ Designated as safety issue: No ]
- Adverse events [ Time Frame: 3 & 12 months post-randomization ] [ Designated as safety issue: Yes ]
| Estimated Enrollment: | 350 |
| Study Start Date: | May 2009 |
| Estimated Study Completion Date: | May 2014 |
| Estimated Primary Completion Date: | May 2014 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| Experimental: Recurrent IVF implantation failure |
Procedure: Lipiodol + IVF
IVF preceded by lipiodol
Procedure: IVF
IVF alone
|
| Experimental: Endometriosis |
Procedure: Lipiodol + IVF
IVF preceded by lipiodol
Procedure: IVF
IVF alone
|
Eligibility| Ages Eligible for Study: | 18 Years to 39 Years (Adult) |
| Genders Eligible for Study: | Female |
| Accepts Healthy Volunteers: | No |
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
Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study.
To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below.
For general information, see Learn About Clinical Studies.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00894946
Please refer to this study by its ClinicalTrials.gov identifier: NCT00894946
Contacts
| Contact: Neil Johnson, MD | +64 274360172 | n.johnson@auckland.ac.nz | |
| Contact: Shelley Reilly, MRANZCOG | sreilly@adhb.govt.nz |
Locations
| New Zealand | |
| University of Auckland | Recruiting |
| Auckland, New Zealand | |
| Contact: Neil Johnson, MD +64 274 360172 n.johnson@auckland.ac.nz | |
| Principal Investigator: Neil P Johnson, MD | |
| Sub-Investigator: Shelley J Reilly, MRANZCOG | |
| Sub-Investigator: Cindy M Farquhar, MD | |
| Sub-Investigator: Alistair Stewart | |
Sponsors and Collaborators
University of Auckland, New Zealand
Investigators
| Principal Investigator: | Neil Johnson, MD | University of Auckland, New Zealand |
More Information
| Responsible Party: | Associate Professor Neil Johnson, University of Auckland |
| ClinicalTrials.gov Identifier: | NCT00894946 History of Changes |
| Other Study ID Numbers: | IVF-LUBE |
| Study First Received: | May 6, 2009 |
| Last Updated: | May 6, 2009 |
| Health Authority: | New Zealand: University of Auckland Trial Steering Committee |
Keywords provided by University of Auckland, New Zealand:
|
recurrent IVF implantation failure |
Additional relevant MeSH terms:
|
Endometriosis Genital Diseases, Female Ethiodized Oil Antineoplastic Agents |
ClinicalTrials.gov processed this record on September 27, 2016