Effect of Cervical Occlusion During Intrauterine Insemination (IUI)

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

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

Conditions
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Infertility

Intervention / Treatment
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* Procedure: Intrauterine Insemination
* Procedure: IUI with the standard inseminator


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 20 Years
Maximum Age: 45 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Cervical occulsion<br>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<br>* 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.<br>* Other names: H/SH;|
| Active Comparator: Standard IUI<br>Insemination with TOmcat catheter | Procedure: IUI with the standard inseminator<br>* The control arm will undergo insemination with the standard inseminator (TOmcat catheter).<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Clinical Pregnancy | positive beta HCG test | 1 month | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Live Birth |  | 9 months | 
| Positive Pregnancy Test |  | 14 days |