Effect of Cervical Occlusion During Intrauterine Insemination (IUI)

Infertility Clinical Trial

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00951171
• Other study ID #: CO_IUI
• Status: Terminated
• Phase: Phase 3
• First received: July 31, 2009
• Last updated: August 27, 2012
• Start date: February 2009
• Est. completion date: December 2011

Study information

• Verified date: August 2012
• Source: Women and Infants Hospital of Rhode Island
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 93
• Est. completion date: December 2011
• Est. primary completion date: December 2011
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 20 Years to 45 Years

Eligibility

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

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Infertility

Intervention

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

Locations

Country	Name	City	State
United States	Center for Reproduction and Infertility	Providence	Rhode Island

Sponsors (1)

Lead Sponsor	Collaborator
Women and Infants Hospital of Rhode Island

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Clinical Pregnancy	positive beta HCG test	1 month	No
Secondary	Live Birth		9 months	No
Secondary	Positive Pregnancy Test		14 days	No