NCT00951171

Effect of Cervical Occlusion During Intrauterine Insemination (IUI)

Evaluation of the Effect of Cervical Occlusion During Infertility Treatment by Intrauterine Insemination

• Status: Terminated
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 93 (actual)
• Sponsor: Women and Infants Hospital of Rhode Island · Academic / Other
• Sex: Female
• Age: 20 Years – 45 Years
• Healthy volunteers: Accepted

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.

Conditions

• Infertility

Interventions

Type	Name	Description
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.
PROCEDURE	IUI with the standard inseminator	The control arm will undergo insemination with the standard inseminator (TOmcat catheter).

Timeline

• Start date: 2009-02-01
• Primary completion: 2011-12-01
• Completion: 2011-12-01
• First posted: 2009-08-04
• Last updated: 2012-08-28
• Results posted: 2012-08-28

Locations

1 site across 1 country: United States