Effect of Cervical Occlusion During Intrauterine Insemination (IUI)

Last updated: August 27, 2012
Sponsor: Women and Infants Hospital of Rhode Island
Overall Status: Terminated

Phase

3

Condition

Infertility

Treatment

N/A

Clinical Study ID

NCT00951171
CO_IUI
  • Ages 20-45
  • Female
  • Accepts Healthy Volunteers

Study 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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

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

Exclusion

Exclusion Criteria:

  • "Abnormal" Semenalysis TMC < 5 million

  • Blocked Fallopian tubes

Study Design

Total Participants: 93
Study Start date:
February 01, 2009
Estimated Completion Date:
December 31, 2011

Study 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.

Connect with a study center

  • Center for Reproduction and Infertility

    Providence, Rhode Island 02905
    United States

    Site Not Available

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