Back to resultsEffect of Cervical Occlusion During Intrauterine Insemination (IUI)
Primary Purpose
Infertility
Status
Terminated
Phase
Phase 3
Locations
United States
Study Type
Interventional
Intervention
Intrauterine Insemination
IUI with the standard inseminator
Sponsored by
About this trial
This is an interventional treatment trial for Infertility
Eligibility Criteria
Inclusion Criteria:
- All patients undergoing IUI for unexplained infertility in our office: Center for Reproduction and Infertility (Providence, RI)
Exclusion Criteria:
- "Abnormal" Semenalysis TMC < 5 million
- Blocked Fallopian tubes
Sites / Locations
- Center for Reproduction and Infertility
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Cervical occulsion
Standard IUI
Arm Description
Insemination Eliptosphere catheter filled with 1cc of air for 15 minutes. H/S Eliptosphere by Copper surgical (U.S. Patent No. 5,624,399)
Insemination with TOmcat catheter
Outcomes
Primary Outcome Measures
Clinical Pregnancy
positive beta HCG test
Secondary Outcome Measures
Live Birth
Positive Pregnancy Test
Full Information
NCT ID
NCT00951171
First Posted
July 31, 2009
Last Updated
August 27, 2012
Sponsor
Women and Infants Hospital of Rhode Island
1. Study Identification
Unique Protocol Identification Number
NCT00951171
Brief Title
Effect of Cervical Occlusion During Intrauterine Insemination (IUI)
Official Title
Evaluation of the Effect of Cervical Occlusion During Infertility Treatment by Intrauterine Insemination
Study Type
Interventional
2. Study Status
Record Verification Date
August 2012
Overall Recruitment Status
Terminated
Why Stopped
Randomization flawed. Results were poor in the innovative catheter group
Study Start Date
February 2009 (undefined)
Primary Completion Date
December 2011 (Actual)
Study Completion Date
December 2011 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Women and Infants Hospital of Rhode Island
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
Study Hypothesis: There is a difference in pregnancy rates between intrauterine insemination (IUI) in cycles performed with cervical occlusion by a balloon catheter designed for sonohysterograms as compared to those performed with a standard inseminator.
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
An open speculum will be used and patients will undergo insemination with their partners sperm (same quantity in both arms). If randomized to treatment arm a balloon catheter will be filled with 1cc of air prior to insemination. The speculum will be removed immediately and the catheter will be left in for 15 minutes and then removed. Pregnancy outcomes will be recorded in both groups.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Infertility
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
93 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Cervical occulsion
Arm Type
Experimental
Arm Description
Insemination Eliptosphere catheter filled with 1cc of air for 15 minutes. H/S Eliptosphere by Copper surgical (U.S. Patent No. 5,624,399)
Arm Title
Standard IUI
Arm Type
Active Comparator
Arm Description
Insemination with TOmcat catheter
Intervention Type
Procedure
Intervention Name(s)
Intrauterine Insemination
Other Intervention Name(s)
H/SH
Intervention Description
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.
Intervention Type
Procedure
Intervention Name(s)
IUI with the standard inseminator
Intervention Description
The control arm will undergo insemination with the standard inseminator (TOmcat catheter).
Primary Outcome Measure Information:
Title
Clinical Pregnancy
Description
positive beta HCG test
Time Frame
1 month
Secondary Outcome Measure Information:
Title
Live Birth
Time Frame
9 months
Title
Positive Pregnancy Test
Time Frame
14 days
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
45 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
All patients undergoing IUI for unexplained infertility in our office: Center for Reproduction and Infertility (Providence, RI)
Exclusion Criteria:
"Abnormal" Semenalysis TMC < 5 million
Blocked Fallopian tubes
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Andrew Blazar, MD
Organizational Affiliation
Women & Infants Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Center for Reproduction and Infertility
City
Providence
State/Province
Rhode Island
ZIP/Postal Code
02905
Country
United States
12. IPD Sharing Statement
Learn more about this trial
Effect of Cervical Occlusion During Intrauterine Insemination (IUI)
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