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Effect of Cervical Occlusion During Intrauterine Insemination (IUI)

This study has been terminated.
(Randomization flawed. Results were poor in the innovative catheter group)
Sponsor:
Information provided by (Responsible Party):
Andrew Blazar, M.D., Women and Infants Hospital of Rhode Island
ClinicalTrials.gov Identifier:
NCT00951171
First received: July 31, 2009
Last updated: August 27, 2012
Last verified: August 2012
  Purpose

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.


Condition Intervention Phase
Infertility
Procedure: Intrauterine Insemination
Procedure: IUI with the standard inseminator
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Evaluation of the Effect of Cervical Occlusion During Infertility Treatment by Intrauterine Insemination

Resource links provided by NLM:


Further study details as provided by Women and Infants Hospital of Rhode Island:

Primary Outcome Measures:
  • Clinical Pregnancy [ Time Frame: 1 month ] [ Designated as safety issue: No ]
    positive beta HCG test


Secondary Outcome Measures:
  • Live Birth [ Time Frame: 9 months ] [ Designated as safety issue: No ]
  • Positive Pregnancy Test [ Time Frame: 14 days ] [ Designated as safety issue: No ]

Enrollment: 93
Study Start Date: February 2009
Study Completion Date: December 2011
Primary Completion Date: December 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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).

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.

  Eligibility

Ages Eligible for Study:   20 Years to 45 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00951171

Locations
United States, Rhode Island
Center for Reproduction and Infertility
Providence, Rhode Island, United States, 02905
Sponsors and Collaborators
Women and Infants Hospital of Rhode Island
Investigators
Principal Investigator: Andrew Blazar, MD Women & Infants Hospital
  More Information

No publications provided

Responsible Party: Andrew Blazar, M.D., Prinicpal Investigator, Women and Infants Hospital of Rhode Island
ClinicalTrials.gov Identifier: NCT00951171     History of Changes
Other Study ID Numbers: CO_IUI
Study First Received: July 31, 2009
Results First Received: July 10, 2012
Last Updated: August 27, 2012
Health Authority: United States: Institutional Review Board

Additional relevant MeSH terms:
Infertility
Genital Diseases, Female
Genital Diseases, Male

ClinicalTrials.gov processed this record on November 20, 2014