Effect of Cervical Occlusion During Intrauterine Insemination (IUI)

Status Terminated

Clinical Trial 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.

Clinical Trial 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. ;

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

Infertility

Clinical Trial Details

NCT number	NCT00951171
Study type	Interventional
Source	Women and Infants Hospital of Rhode Island
Contact
Status	Terminated
Phase	Phase 3
Start date	February 2009
Completion date	December 2011

View Details

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