TerminatedNot Applicable

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

Stopped: After reviewing the interim analysis results the study was terminated as a bigger sample size was needed to find a significant difference between the groups.

Canada450 participantsStarted 2014-01

Plain-language 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.

Who can participate

Age range

18 Years – 40 Years

Sex

FEMALE

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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.

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Pregnancy Rate

Timeframe: 19months

Trial details

NCT IDNCT02445092

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

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2016-07

View on ClinicalTrials.gov More Infertility trials