Description Module
The Description Module contains narrative descriptions of the clinical trial, including a brief summary and detailed description. These descriptions provide important information about the study's purpose, methodology, and key details in language accessible to both researchers and the general public.
Description Module path is as follows:
Study -> Protocol Section -> Description Module
Description Module
Ignite Creation Date:
2025-12-24 @ 3:43 PM
Ignite Modification Date:
2025-12-24 @ 3:43 PM
NCT ID:
NCT02445092
Brief 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.
Detailed 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:
NCT02445092
Study Brief:
Protocol Section:
NCT02445092