Clinical trial NCT02445092: The Effect of Pre-washing the Insemination Catheter on Pregnancy Outcome
Official title: Double Blind Randomized Controlled Trial on the Effect of Pre-washing the Insemination Catheter on Pregnancy Outcome
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Infertility
Pregnancy
Keywords: Intrauterine insemination
Insemination catheter prewashing
Pregnancy outcome
Lead sponsor: McGill University Health Centre/Research Institute of the McGill University Health Centre
Sponsor class: OTHER
First posted: 2015-05-15
Enrollment: 450
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: BASIC_SCIENCE

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.

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.

Primary outcomes:
measure: Pregnancy Rate
timeFrame: 19months
Secondary outcomes:
measure: Ectopic Pregnancy Rate
timeFrame: 19 months
measure: Clinical pregnancy rate
timeFrame: 19 months
measure: miscarriage Rate
timeFrame: 19 months
measure: Live birth rate
timeFrame: 19 months
Other outcomes:
Locations:
city: Montreal
country: Canada
facility: MUHC reproductive center
state: Quebec
Study officials:
affiliation: MUHC reproductive center
name: Patricia Monnier, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.