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

September 25, 2016 updated by: Patricia Monnier, McGill University Health Centre/Research Institute of the McGill University Health Centre

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.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

450

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Canada
    • Quebec
      • Montreal, Quebec, Canada, H3A 1A1
        • MUHC reproductive center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 40 years (ADULT)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

Female

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: BASIC_SCIENCE
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: DOUBLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Catheter prewashing

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.
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.
No Intervention: Control group
450 patients randomly assigned in this group will have their insemination performed routinely, without washing the insemination catheter..

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Pregnancy Rate
Time Frame: 19months
To determine if pre-washing the catheter before insemination improves the pregnancy outcome in women undergoing IUI.
19months

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

McGill University Health Centre/Research Institute of the McGill University Health Centre

Investigators

  • Principal Investigator: Patricia Monnier, MD, MUHC reproductive center

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2014

Primary Completion (Actual)

July 1, 2016

Study Completion (Actual)

September 1, 2016

Study Registration Dates

First Submitted

January 8, 2014

First Submitted That Met QC Criteria

May 14, 2015

First Posted (Estimate)

May 15, 2015

Study Record Updates

Last Update Posted (Estimate)

September 27, 2016

Last Update Submitted That Met QC Criteria

September 25, 2016

Last Verified

September 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 13-158-SDR

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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