Effect of Cervical Occlusion During Intrauterine Insemination (IUI)

NCT00951171 | Terminated Phase 3 Results

• 1 other identifier: CO_IUI
• Study Type: interventional
• Target: 93
• Locations: 1 country
• Sites: 1

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.

Conditions

Infertility

Outcome Measures

Primary Outcomes (1)

• Clinical Pregnancy

  positive beta HCG test

  1 month

Secondary Outcomes (2)

• Live Birth

  9 months

• Positive Pregnancy Test

  14 days

Study Arms (2)

Cervical occulsion

EXPERIMENTAL

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

Standard IUI

ACTIVE COMPARATOR

Insemination with TOmcat catheter

Procedure: IUI with the standard inseminator

Interventions

Intrauterine Insemination PROCEDURE

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.

Also known as: H/SH

Cervical occulsion

IUI with the standard inseminator PROCEDURE

The control arm will undergo insemination with the standard inseminator (TOmcat catheter).

Standard IUI

Eligibility Criteria

• Age: 20 Years - 45 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Women and Infants Hospital of Rhode Island: lead

Study Sites (1)

Center for Reproduction and Infertility

Providence, Rhode Island, 02905, United States

Location

MeSH Terms

Conditions

Infertility

Condition Hierarchy (Ancestors)

Genital Diseases; Urogenital Diseases

Limitations and Caveats

Randomization method found to be faulty

Results Point of Contact

• Title: Andrew S Blazar, MD Principal Investigator
• Organization: WIHRI

ablazar@WIHRI.org

401-274-1122

Study Officials

• Andrew Blazar, MD

  Women & Infants Hospital

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Prinicpal Investigator

Study Record Dates

• First Submitted: July 31, 2009
• First Posted: August 4, 2009
• Study Start: February 1, 2009
• Primary Completion: December 1, 2011
• Study Completion: December 1, 2011
• Last Updated: August 28, 2012
• Results First Posted: August 28, 2012

Record last verified: 2012-08

Locations

US (1)