Effect of Cervical Occlusion During Intrauterine Insemination (IUI)
NCT ID: NCT00951171
Last Updated: 2012-08-28
Study Results
Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.
View full resultsBasic Information
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TERMINATED
PHASE3
93 participants
INTERVENTIONAL
2009-02-28
2011-12-31
Brief Summary
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The investigators will compare pregnancy rates in patients undergoing routine IUI either with balloon occlusion or with standard insemination. The patients will receive the standard clinical care per the investigators' office guidelines, except they will be randomized to insemination with either of two catheters.
Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Cervical occulsion
Insemination Eliptosphere catheter filled with 1cc of air for 15 minutes. H/S Eliptosphere by Copper surgical (U.S. Patent No. 5,624,399)
Intrauterine Insemination
The intervention arm will undergo temporary (15 minutes) cervical occlusion with the eliptosphere intracervical catheter. This catheter is typically used to perform saline infusion ultrasounds to image the uterine cavity in our practice.
Standard IUI
Insemination with TOmcat catheter
IUI with the standard inseminator
The control arm will undergo insemination with the standard inseminator (TOmcat catheter).
Interventions
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Intrauterine Insemination
The intervention arm will undergo temporary (15 minutes) cervical occlusion with the eliptosphere intracervical catheter. This catheter is typically used to perform saline infusion ultrasounds to image the uterine cavity in our practice.
IUI with the standard inseminator
The control arm will undergo insemination with the standard inseminator (TOmcat catheter).
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
* Blocked Fallopian tubes
20 Years
45 Years
FEMALE
Yes
Sponsors
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Women and Infants Hospital of Rhode Island
OTHER
Responsible Party
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Andrew Blazar, M.D.
Prinicpal Investigator
Principal Investigators
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Andrew Blazar, MD
Role: PRINCIPAL_INVESTIGATOR
Women & Infants Hospital
Locations
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Center for Reproduction and Infertility
Providence, Rhode Island, United States
Countries
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Other Identifiers
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CO_IUI
Identifier Type: -
Identifier Source: org_study_id