The Effect of Pre-washing the Insemination Catheter on Pregnancy Outcome

Status Terminated

Clinical Trial Summary

The investigators hypothesize that washing the insemination catheter prior to performing the IUI (intrauterine insemination) will improve the pregnancy outcome in IUI cycles when compared to controls (without pre-washing the catheter).

Catheter washing is performed routinely before embryo transfer, however it is not done for IUI catheters. Therefore no data is available on applying the technique to IUI catheters prior to insemination.

Clinical Trial Description

OBJECTIVES:

Primary objective:

To determine if pre-washing the catheter before insemination improves the pregnancy outcome in women undergoing IUI.

Secondary objectives:

1. To evaluate the impact of pre-washing the catheter before insemination on the ectopic pregnancy rate in women undergoing IUI.

2. To evaluate the impact of pre-washing the catheter before insemination on the miscarriage rate in women undergoing IUI.

3. To evaluate the impact of pre-washing the catheter before insemination on the multiple pregnancy rates in women undergoing IUI.

STUDY DESIGN:

The study will be a prospective double blind trial among women undergoing IUI at the MUHC reproductive centre using a cluster randomized design. The week will be defined as the unit for the clusters of randomization. Weeks will be allocated to one of the following groups:

- Group 1 = pre-washing group (patients will have the IUI with a pre-washed catheter during that week)

- Group 2 = control group (no pre-washing before IUI during that week)

A random block size will be used to minimize the risk of non-blinding. The study is double-blind, neither the patients nor the physicians performing IUI will know whether the catheter was washed or not, as both the sample and the catheter will be prepared by the andrology lab technician. The cluster randomization design is justified since the management of the unit will not allow us to perform a randomization at the patient level.

However a very low Intra-Correlation Coefficient (ICC) between patients is expected. ;

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver), Primary Purpose: Basic Science

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT02445092
Study type	Interventional
Source	McGill University Health Center
Contact
Status	Terminated
Phase	N/A
Start date	January 2014
Completion date	September 2016

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Clinical trials are conducted in a series of steps, called phases - each phase is designed to answer a separate research question.

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.