Ignite Creation Date:
2025-12-24 @ 3:43 PM
Ignite Modification Date:
2025-12-29 @ 10:06 PM
Study NCT ID:
NCT02445092
Status:
TERMINATED
Last Update Posted:
2016-09-27
First Post:
2014-01-08
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
The Effect of Pre-washing the Insemination Catheter on Pregnancy Outcome
Sponsor:
McGill University Health Centre/Research Institute of the McGill University Health Centre
Organization:
Study Overview
Official Title:
Double Blind Randomized Controlled Trial on the Effect of Pre-washing the Insemination Catheter on Pregnancy Outcome
Status:
TERMINATED
Status Verified Date:
2016-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
After reviewing the interim analysis results the study was terminated as a bigger sample size was needed to find a significant difference between the groups.
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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.
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.
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 Oversight
Has Oversight DMC:
True
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: