Effect of Cervical Occlusion During Intrauterine Insemination (IUI)
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.
|Infertility||Procedure: Intrauterine Insemination Procedure: IUI with the standard inseminator||Phase 3|
|Study Design:||Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
|Official Title:||Evaluation of the Effect of Cervical Occlusion During Infertility Treatment by Intrauterine Insemination|
- Clinical Pregnancy [ Time Frame: 1 month ]positive beta HCG test
- Live Birth [ Time Frame: 9 months ]
- Positive Pregnancy Test [ Time Frame: 14 days ]
|Study Start Date:||February 2009|
|Study Completion Date:||December 2011|
|Primary Completion Date:||December 2011 (Final data collection date for primary outcome measure)|
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)
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
Active Comparator: Standard IUI
Insemination with TOmcat catheter
Procedure: IUI with the standard inseminator
The control arm will undergo insemination with the standard inseminator (TOmcat catheter).
Please refer to this study by its ClinicalTrials.gov identifier: NCT00951171
|United States, Rhode Island|
|Center for Reproduction and Infertility|
|Providence, Rhode Island, United States, 02905|
|Principal Investigator:||Andrew Blazar, MD||Women & Infants Hospital|