InfertilityNCT02445092
The Effect of Pre-washing the Insemination Catheter on Pregnancy Outcome
A study testing washing the insemination catheter with sperm washing media in people with Infertility and Pregnancy, run by McGill University Health Centre/Research Institute of the McGill University Health Centre at 1 site in Canada.
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). Read more about this study
- Who is it for?
- Ages 18 to 40 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Infertility, Pregnancy
- What is being tested?
- washing the insemination catheter with sperm washing media
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 450 participants
- Where
- 1 siteCanada
- Study dates
- Jan 2014to Sep 2016
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 40 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Double Blind Randomized Controlled Trial on the Effect of Pre-washing the Insemination Catheter on Pregnancy Outcome
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.
Read the detailed description
OBJECTIVES:
Primary objective:
To determine if pre-washing the catheter before insemination improves the pregnancy outcome in women undergoing IUI.
Secondary objectives:
- To evaluate the impact of pre-washing the catheter before insemination on the ectopic pregnancy rate in women undergoing IUI.
- To evaluate the impact of pre-washing the catheter before insemination on the miscarriage rate in women undergoing IUI.
- 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
- Being tested
- washing the insemination catheter with sperm washing media
- Keywords
- Intrauterine insemination, Insemination catheter prewashing, Pregnancy outcome
- Medical subject headings
- Infertility
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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.. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pregnancy Rate
To determine if pre-washing the catheter before insemination improves the pregnancy outcome in women undergoing IUI.
Measured: 19months
Secondary outcomes (4)
Ectopic Pregnancy Rate
- To evaluate the impact of pre-washing the catheter before insemination on the ectopic pregnancy rate in women undergoing IUI.
Measured: 19 months
Clinical pregnancy rate
- To evaluate the impact of pre-washing the catheter before insemination on the clinical pregnancy rate in women undergoing IUI.
Measured: 19 months
miscarriage Rate
- To evaluate the impact of pre-washing the catheter before insemination on the miscarriage rates in women undergoing IUI.
Measured: 19 months
Live birth rate
To evaluate the impact of pre-washing the catheter before insemination on the live birth rates in women undergoing IUI.
Measured: 19 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 May 2015 (estimated)
- Study startJan 2014
- Primary completionJul 2016
- Study completionSep 2016
Why it 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.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for InfertilityStudies of the same condition, open and under way.
- More trials run by McGill University Health Centre/Research Institute of the McGill University Health CentreThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Care provider
- Enrolment
- 450 participants (actual)
Sponsor and investigators
- Lead sponsor
- McGill University Health Centre/Research Institute of the McGill University Health Centre
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Patricia Monnier, McGill University Health Centre/Research Institute of the McGill University Health Centre
- Investigators
- Patricia Monnier, MD, Principal investigator, MUHC reproductive center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02445092
- Sponsor's protocol ID
- 13-158-SDR
- Status last verified
- Sep 2016
- First submitted
- 8 Jan 2014
- Last updated
- 27 Sep 2016
- Results posted
- No
- Data monitoring committee
- Yes
Publications
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.
PubMed 22503402
Study at a glance
From the registry record, last updated by the sponsor on 27 Sep 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Double Blind Randomized Controlled Trial on the Effect of Pre-washing the Insemination Catheter on Pregnancy Outcome
- ClinicalTrials.gov ID
- NCT02445092
- Acronym / sponsor ID
- 13-158-SDR
- Conditions
- Infertility, Pregnancy
- Keywords
- Intrauterine insemination, Insemination catheter prewashing, Pregnancy outcome
- Study type
- Interventional
- Recruitment status
- TerminatedReason 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.
- Enrolment
- 450 participants (actual)
- Lead sponsor
- McGill University Health Centre/Research Institute of the McGill University Health CentreUniversity, hospital or other
- Study start
- Jan 2014
- Primary completion
- Jul 2016 (actual)
- Study completion
- Sep 2016 (actual)
- First posted
- 15 May 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- To evaluate the impact of pre-washing the catheter before insemination on the ectopic pregnancy rate in women undergoing IUI.
- To evaluate the impact of pre-washing the catheter before insemination on the miscarriage rate in women undergoing IUI.
- 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.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, care provider)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Catheter prewashing | Experimental | Other: washing the insemination catheter with sperm washing mediaIntervention: 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. |
| Control group | No intervention | –450 patients randomly assigned in this group will have their insemination performed routinely, without washing the insemination catheter.. |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- 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.
Key exclusion criteria (6 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| washing the insemination catheter with sperm washing mediaIntervention: 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. | Other | Catheter prewashing |
Primary outcome
Pregnancy Rate
Time frame: 19months
To determine if pre-washing the catheter before insemination improves the pregnancy outcome in women undergoing IUI.
4 secondary outcomes
Ectopic Pregnancy Rate
Time frame: 19 months
Clinical pregnancy rate
Time frame: 19 months
miscarriage Rate
Time frame: 19 months
Live birth rate
Time frame: 19 months
Results and safety
The study was stopped early (reason given: 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.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Sep 2016.
- Background: PubMed 22503402Pont 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Patricia Monnier, MD principal investigator
MUHC reproductive center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing washing the insemination catheter with sperm washing media in people with Infertility and Pregnancy, run by McGill University Health Centre/Research Institute of the McGill University Health Centre at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 27 Sep 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: 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.). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pregnancy Rate (time frame: 19months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02445092, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Sep 2016.