Effect of Cervical Occlusion During Intrauterine Insemination (IUI)

Women and Infants Hospital of Rhode Island

Status and phase: Terminated; Phase 3

Conditions: Infertility

Treatments: Procedure: Intrauterine Insemination; Procedure: IUI with the standard inseminator

Study type: Interventional

Funder types: Other

Identifiers

NCT00951171

CO_IUI

Details and patient eligibility

About

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.

Full 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.

Enrollment: 93 patients

Sex: Female

Ages: 20 to 45 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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93 participants in 2 patient groups

Cervical occulsion

Experimental group

Description:

Insemination Eliptosphere catheter filled with 1cc of air for 15 minutes. H/S Eliptosphere by Copper surgical (U.S. Patent No. 5,624,399)

Treatment:

Procedure: Intrauterine Insemination

Standard IUI

Active Comparator group

Description:

Insemination with TOmcat catheter

Treatment:

Procedure: IUI with the standard inseminator