Infertility Clinical Trial
Official title:
Double Blind Randomized Controlled Trial on the Effect of Pre-washing the Insemination Catheter on Pregnancy Outcome
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.
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.
;
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver), Primary Purpose: Basic Science
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