Effect of Cervical Occlusion During Intrauterine Insemination (IUI)

Phase 3

Terminated

• Conditions: Infertility
• Interventions: Procedure: Intrauterine Insemination; Procedure: IUI with the standard inseminator

• Registration Number: NCT00951171
• Lead Sponsor: Women and Infants Hospital of Rhode Island

Brief 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.

Study Timeline

• Study Start: 2009-02
• Study First Submitted: 2009-07-31
• Study First Submitted QC: 2009-08-03
• Study First Posted: 2009-08-04
• Primary Completion: 2011-12
• Study Completion: 2011-12
• Results First Submitted: 2012-07-10
• Status Verified: 2012-08
• Results First Submitted QC: 2012-08-27
• Last Update Submitted: 2012-08-27
• Results First Posted: 2012-08-28
• Last Update Posted: 2012-08-28

Recruitment & Eligibility

• Status: TERMINATED
• Sex: Female
• Target Recruitment: 93

Inclusion Criteria

• All patients undergoing IUI for unexplained infertility in our office: Center for Reproduction and Infertility (Providence, RI)

Exclusion Criteria

• "Abnormal" Semenalysis TMC < 5 million
• Blocked Fallopian tubes

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Cervical occulsion	Intrauterine Insemination	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	IUI with the standard inseminator	Insemination with TOmcat catheter

Primary Outcome Measures

Name	Time	Method
Clinical Pregnancy	1 month	positive beta HCG test

Secondary Outcome Measures

Name	Time	Method
Live Birth	9 months
Positive Pregnancy Test	14 days

Trial Locations

Locations (1)

Center for Reproduction and Infertility; 🇺🇸 Providence, Rhode Island, United States