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

NCT ID: NCT02445092

Last Updated: 2016-09-27

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: NA
• Total Enrollment: 450 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2014-01-31
• Study Completion Date: 2016-09-30

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.

Conditions

Infertility; Pregnancy

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: BASIC_SCIENCE
• Blinding Strategy: DOUBLE

Study Groups

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.

Group Type: EXPERIMENTAL

washing the insemination catheter with sperm washing media

Intervention Type: OTHER

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.

Control group

450 patients randomly assigned in this group will have their insemination performed routinely, without washing the insemination catheter..

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

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.

Intervention Type: OTHER

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 40 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: Yes

Sponsors

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

OTHER

Sponsor Role: lead

Responsible Party

Patricia Monnier

Associate Professor at MUHC reproductive health center

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Patricia Monnier, MD

Role: PRINCIPAL_INVESTIGATOR

MUHC reproductive center

Locations

MUHC reproductive center

Montreal, Quebec, Canada

Countries

Canada

References

Pont JC, Patrat C, Fauque P, Camp ML, Gayet V, Wolf JP. [Pre-washing catheter dramatically improves the post intrauterine insemination pregnancy rate]. Gynecol Obstet Fertil. 2012 Jun;40(6):356-9. doi: 10.1016/j.gyobfe.2012.02.002. Epub 2012 Apr 13. French.

Reference Type: BACKGROUND

PMID: 22503402 (View on PubMed)

Other Identifiers

13-158-SDR

Identifier Type: -

Identifier Source: org_study_id