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

Not Applicable

Terminated

• Conditions: Infertility; Pregnancy
• Interventions: Other: washing the insemination catheter with sperm washing media

• Registration Number: NCT02445092
• Lead Sponsor: McGill University Health Centre/Research Institute of the McGill University Health Centre

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 Timeline

• Study Start: 2014-01
• Study First Submitted: 2014-01-08
• Study First Submitted QC: 2015-05-14
• Study First Posted: 2015-05-15
• Primary Completion: 2016-07
• Status Verified: 2016-09
• Study Completion: 2016-09
• Last Update Submitted: 2016-09-25
• Last Update Posted: 2016-09-27

Recruitment & Eligibility

• Status: TERMINATED
• Sex: Female
• Target Recruitment: 450

Inclusion Criteria

• Infertile women age ranges from 18 to 40 years at the time of treatment at the MUHC reproductive centre.
• Patients undergoing IUI.
• Fresh and frozen sperm treatment cycles
• Hormone induced and natural cycle (no hormonal stimulation).
• Patients speaking English or/and French.
• Patients able to consent.

Exclusion Criteria

• Patients younger than 18 years or older than 40 years of age.
• Patients undergoing ovarian stimulation without IUI.
• Patients who have been recruited in our study in a previous IUI cycle.
• Patients who don't speak English or French.
• Patients who are not able or refuse to consent.
• Patient who are recruited in a different IUI research study.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Catheter prewashing	washing the insemination catheter with sperm washing media	Intervention: prewashing the catheter before IUI. 450 patients randomly included in this group will have their insemination catheter prewashed with the same media used to wash the sperm, prior to performing the insemination using the washed catheter.

Primary Outcome Measures

Name	Time	Method
Pregnancy Rate	19months	To determine if pre-washing the catheter before insemination improves the pregnancy outcome in women undergoing IUI.

Secondary Outcome Measures

Name	Time	Method
Clinical pregnancy rate	19 months	2. To evaluate the impact of pre-washing the catheter before insemination on the clinical pregnancy rate in women undergoing IUI.
miscarriage Rate	19 months	3. To evaluate the impact of pre-washing the catheter before insemination on the miscarriage rates in women undergoing IUI.
Live birth rate	19 months	To evaluate the impact of pre-washing the catheter before insemination on the live birth rates in women undergoing IUI.
Ectopic Pregnancy Rate	19 months	1. To evaluate the impact of pre-washing the catheter before insemination on the ectopic pregnancy rate in women undergoing IUI.

Trial Locations

Locations (1)

MUHC reproductive center; 🇨🇦 Montreal, Quebec, Canada