NCT02445092

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

Double Blind Randomized Controlled Trial on the Effect of Pre-washing the Insemination Catheter on Pregnancy Outcome

• Status: Terminated
• Phase: N/A
• Study type: Interventional
• Enrollment: 450 (actual)
• Sponsor: McGill University Health Centre/Research Institute of the McGill University Health Centre · Academic / Other
• Sex: Female
• Age: 18 Years – 40 Years
• Healthy volunteers: Accepted

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.

Conditions

• Infertility
• Pregnancy

Interventions

Type	Name	Description
OTHER	washing the insemination catheter with sperm washing media	Intervention: pre-washing of the IUI catheter Throughout the research period all of the insemination catheters used for patients recruited in our study, will be prepared as follows: * Connection: The catheter used for insemination, will be connected to the sperm filled syringe as per our standard procedure. * Catheter washing: The sperm washing media will be aspirated and then flushed through the insemination catheter.. * Sperm loading: catheters washed or not connected to the syringe will be loaded with the washed sperm sample as our standard procedure. Labeling: Patient identification data will be labeled on the syringe and place back in the original package cover to ensure proper blinding and sterility of the catheter.

Timeline

• Start date: 2014-01-01
• Primary completion: 2016-07-01
• Completion: 2016-09-01
• First posted: 2015-05-15
• Last updated: 2016-09-27

Locations

1 site across 1 country: Canada