Effect of Cervical Occlusion During Intrauterine Insemination (IUI)
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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 |
- Clinical Pregnancy [ Time Frame: 1 month ] [ Designated as safety issue: No ]positive beta HCG test
- 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 |
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| United States, Rhode Island | |
| Center for Reproduction and Infertility | |
| Providence, Rhode Island, United States, 02905 | |
| 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, Male Genital Diseases, Female |
ClinicalTrials.gov processed this record on June 18, 2013