NCT02445092

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.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
450

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jan 2014

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2014

Completed
7 days until next milestone

First Submitted

Initial submission to the registry

January 8, 2014

Completed
1.3 years until next milestone

First Posted

Study publicly available on registry

May 15, 2015

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2016

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2016

Completed
Last Updated

September 27, 2016

Status Verified

September 1, 2016

Enrollment Period

2.5 years

First QC Date

January 8, 2014

Last Update Submit

September 25, 2016

Conditions

InfertilityPregnancy

Keywords

Intrauterine inseminationInsemination catheter prewashingPregnancy outcome

Outcome Measures

Primary Outcomes (1)

  • Pregnancy Rate

    To determine if pre-washing the catheter before insemination improves the pregnancy outcome in women undergoing IUI.

    19months

Secondary Outcomes (4)

  • Ectopic Pregnancy Rate

    19 months

  • Clinical pregnancy rate

    19 months

  • miscarriage Rate

    19 months

  • Live birth rate

    19 months

Study Arms (2)

Catheter prewashing

EXPERIMENTAL

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

Control group

NO INTERVENTION

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

Interventions

washing the insemination catheter with sperm washing mediaOTHER

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.

Catheter prewashing

Eligibility Criteria

Age18 Years - 40 Years
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

MUHC reproductive center

Montreal, Quebec, H3A 1A1, Canada

Location

Related 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.

    PMID: 22503402BACKGROUND

MeSH Terms

Conditions

Infertility

Condition Hierarchy (Ancestors)

Genital DiseasesUrogenital Diseases

Study Officials

  • Patricia Monnier, MD

    MUHC reproductive center

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, CARE PROVIDER
Purpose
BASIC SCIENCE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor at MUHC reproductive health center

Study Record Dates

First Submitted

January 8, 2014

First Posted

May 15, 2015

Study Start

January 1, 2014

Primary Completion

July 1, 2016

Study Completion

September 1, 2016

Last Updated

September 27, 2016

Record last verified: 2016-09

Locations

CA(1)