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

Infertility Clinical Trial

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT02445092
• Other study ID #: 13-158-SDR
• Status: Terminated
• Phase: N/A
• First received: January 8, 2014
• Last updated: September 25, 2016
• Start date: January 2014
• Est. completion date: September 2016

Study information

• Verified date: September 2016
• Source: McGill University Health Center
• Contact: n/a
• Is FDA regulated: No
• Health authority: Canada: Ethics Review Committee
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 450
• Est. completion date: September 2016
• Est. primary completion date: July 2016
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years to 40 Years

Eligibility

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

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver), Primary Purpose: Basic Science

Related Conditions & MeSH terms

• Infertility
• Pregnancy

Intervention

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.

Locations

Country	Name	City	State
Canada	MUHC reproductive center	Montreal	Quebec

Sponsors (1)

Lead Sponsor	Collaborator
McGill University Health Center

Country where clinical trial is conducted

Canada, 

References & Publications (1)

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Pregnancy Rate	To determine if pre-washing the catheter before insemination improves the pregnancy outcome in women undergoing IUI.	19months	No
Secondary	Ectopic Pregnancy Rate	1. To evaluate the impact of pre-washing the catheter before insemination on the ectopic pregnancy rate in women undergoing IUI.	19 months	No
Secondary	Clinical pregnancy rate	2. To evaluate the impact of pre-washing the catheter before insemination on the clinical pregnancy rate in women undergoing IUI.	19 months	No
Secondary	miscarriage Rate	3. To evaluate the impact of pre-washing the catheter before insemination on the miscarriage rates in women undergoing IUI.	19 months	No
Secondary	Live birth rate	To evaluate the impact of pre-washing the catheter before insemination on the live birth rates in women undergoing IUI.	19 months	No