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Randomization flawed. Results were poor in the innovative catheter group
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Cervical occulsion | Experimental | Insemination Eliptosphere catheter filled with 1cc of air for 15 minutes. H/S Eliptosphere by Copper surgical (U.S. Patent No. 5,624,399) |
|
| Standard IUI | Active Comparator | Insemination with TOmcat catheter |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Intrauterine Insemination | Procedure | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Clinical Pregnancy | positive beta HCG test | 1 month |
| Measure | Description | Time Frame |
|---|---|---|
| Live Birth | 9 months | |
| Positive Pregnancy Test | 14 days |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Andrew Blazar, MD | Women & Infants Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Center for Reproduction and Infertility | Providence | Rhode Island | 02905 | United States |
2 patients in the occlusion group experienced pain and were immediately transferrred to the standard group,thereby creating an apparent discrepancy in numbers
All patients recruited were women scheduled previously for IUI for treatment of unexplained infertility at the WIHRI office.
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| ID | Title | Description |
|---|---|---|
| FG000 | 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) |
| FG001 | Standard IUI | Insemination with TOmcat catheter |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | 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) |
| BG001 | Standard IUI |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Clinical Pregnancy | positive beta HCG test | All study women undergoing IUI were included | Posted | Number | positive pregnancy test (beta HCG) | 1 month |
|
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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) |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| pain with device | Surgical and medical procedures | Non-systematic Assessment |
Randomization method found to be faulty
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Andrew S Blazar, MD Principal Investigator | WIHRI | 401-274-1122 | 8461 | ablazar@WIHRI.org |
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| ID | Term |
|---|---|
| D007246 | Infertility |
| ID | Term |
|---|---|
| D000091662 | Genital Diseases |
| D000091642 | Urogenital Diseases |
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|
| IUI with the standard inseminator | Procedure | The control arm will undergo insemination with the standard inseminator (TOmcat catheter). |
|
Insemination with TOmcat catheter
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Units |
|---|
| Counts |
|---|
| Participants |
|
|
| Secondary | Live Birth | Not Posted | 9 months |
| Secondary | Positive Pregnancy Test | Not Posted | 14 days |
| 0 |
| 40 |
| 2 |
| 40 |
| EG001 | Standard IUI | Insemination with TOmcat catheter | 0 | 55 | 0 | 55 |
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