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| Sponsor: | Women and Infants Hospital of Rhode Island |
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| Information provided by: | Women and Infants Hospital of Rhode Island |
| ClinicalTrials.gov Identifier: | NCT00951171 |
Purpose
Study Hypothesis: There is a difference in pregnancy rates between 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.
| Condition | Intervention | Phase |
|---|---|---|
|
Infertility |
Procedure: Intrauterine Insemination Procedure: IUI with the standard inseminator |
Phase III |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | Evaluation of the Effect of Cervical Occlusion During Infertility Treatment by Intrauterine Insemination |
| Estimated Enrollment: | 160 |
| Study Start Date: | February 2009 |
| Estimated Study Completion Date: | December 2010 |
| Estimated Primary Completion Date: | December 2010 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: 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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Procedure: 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.
Other Name: H/SH
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Active Comparator: Standard IUI
Insemination with TOmcat catheter
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Procedure: IUI with the standard inseminator
The control arm will undergo insemination with the standard inseminator (TOmcat catheter).
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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.
Eligibility| Ages Eligible for Study: | 20 Years to 45 Years |
| Genders Eligible for Study: | Female |
| Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
Exclusion Criteria:
Contacts and Locations| Contact: Andrew Blazar, MD | 401.274.1122 ext 8140 | ablazar@wihri.org |
| United States, Rhode Island | |
| Center for Reproduction and Infertility | Recruiting |
| Providence, Rhode Island, United States, 02905 | |
| Contact: Lilian Czech, RN 401-274-1122 ext 7131 lczech@wihri.org | |
| Sub-Investigator: Peter C Klatsky, MD, MPH | |
| Principal Investigator: Andrew Blazar, MD | |
| Principal Investigator: | Andrew Blazar, MD | Women & Infants Hospital |
More Information
| Responsible Party: | Dr. Andrew Blazar, Women & Infants' Hospital |
| ClinicalTrials.gov Identifier: | NCT00951171 History of Changes |
| Other Study ID Numbers: | CO_IUI |
| Study First Received: | July 31, 2009 |
| Last Updated: | August 3, 2009 |
| Health Authority: | United States: Institutional Review Board |
|
Infertility Genital Diseases, Male Genital Diseases, Female |
