InfertilityNCT00737984
Improving the Pregnancy Rate With Endometrial Sampling Before Intrauterine Insemination
A study testing Endometrial sampling in people with Infertility and Clinical Pregnancy Rate, run by McGill University Health Centre/Research Institute of the McGill University Health Centre at 1 site in Canada.
Trial summary
Endometrial sampling improves the pregnancy rates in superovulation-IUI cycles Read more about this study
- Who is it for?
- Any age, women only
- Conditions the study is for
- Infertility, Clinical Pregnancy Rate
- What is being tested?
- Endometrial sampling
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 9 participants
- Where
- 1 siteCanada
- Study dates
- Aug 2008to Aug 2011
- 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 Any age
- Women only
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- All women undergoing superovulation with gonadotrophins and intrauterine insemination.
- All women with cervical factor, mild male factor and/or unexplained infertility.
- At least one patent Fallopian tube.
Who cannot join
- Bilateral tubal disease
- Severe male factor infertility
- Intrauterine pathology (submucosal fibroid, endometrial polyp, adhesions)
- Women with positive cervical culture and/or acute vaginal infection
Trial locations and contacts
1 site in 1 country.
About this study
Endometrial sampling improves the pregnancy rates in superovulation-IUI cycles
Read the detailed description
Endometrial sampling is performed using the standard technique in the outpatient department. Similarly, superovulation with gonadotrophins will be performed according to our standard practice.Endometrial sampling will be done in the follicular phase not later than day 10 of the cycle. Endometrial sampling will be performed using Pipelle sampling catheter. The Pipelle is inserted gently through the cervical canal into the uterine cavity and advanced slowly till just resistance felt by the operator. Then, the piston is withdrawn to create negative suction and gentle movement of Pipelle up and down in the uterine cavity is performed while it is against the uterine wall. The Pipelle catheter is withdrawn gently and any obtained specimen will be sent for histopathological examination.
- Conditions
- Infertility, Clinical Pregnancy Rate
- Being tested
- Endometrial sampling
- Keywords
- Infertility, Clinical pregnancy rate
- Medical subject headings
- Infertility
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Endometrial samplingProcedure or surgery
Also called Intrauterine insemination, Clinical pregnancy rate
Endometrial sampling performed in the preceding cycle. It will be done in the follicular phase not later than day 10 of the cycle
| Study group | Role | What they receive |
|---|---|---|
| 1 | No intervention | Group 1 patients will receive standard superovulation-IUI treatment without endometrial sampling |
| 2 | Active comparator | Group 2 patients will receive standard superovulation-IUI treatment with endometrial sampling performed in the preceding cycle. It will be done in the follicular phase not later than day 10 of the cycle Receives: Procedure: Endometrial sampling |
What is being measured
The primary outcome is the main question the study is designed to answer.
The rate of clinical pregnancy
Measured: 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Aug 2008 (estimated)
- Study startAug 2008
- Primary completionAug 2011
- Study completionAug 2011
Why it stopped: Because very low number of patients were enrolled
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)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
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 9 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, Mohammed Agdi, McGill University Health Centre/Research Institute of the McGill University Health Centre
- Investigators
- Togas Tulandi, MD, MHCM, Principal investigator, McGill University Health Centre/Research Institute of the McGill University Health Centre
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00737984
- Sponsor's protocol ID
- SDR-08-004
- Status last verified
- Oct 2009
- First submitted
- 18 Aug 2008
- Last updated
- 20 Apr 2012
- Results posted
- No
- Data monitoring committee
- No
Publications
Raziel A, Schachter M, Strassburger D, Bern O, Ron-El R, Friedler S. Favorable influence of local injury to the endometrium in intracytoplasmic sperm injection patients with high-order implantation failure. Fertil Steril. 2007 Jan;87(1):198-201. doi: 10.1016/j.fertnstert.2006.05.062.
PubMed 17197286Barash A, Dekel N, Fieldust S, Segal I, Schechtman E, Granot I. Local injury to the endometrium doubles the incidence of successful pregnancies in patients undergoing in vitro fertilization. Fertil Steril. 2003 Jun;79(6):1317-22. doi: 10.1016/s0015-0282(03)00345-5.
PubMed 12798877
Study at a glance
From the registry record, last updated by the sponsor on 20 Apr 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Improving the Pregnancy Rate With Endometrial Sampling Before Intrauterine Insemination
- ClinicalTrials.gov ID
- NCT00737984
- Acronym / sponsor ID
- SDR-08-004
- Conditions
- Infertility, Clinical Pregnancy Rate
- Keywords
- Infertility, Clinical pregnancy rate
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Because very low number of patients were enrolled
- Enrolment
- 9 participants (actual)
- Lead sponsor
- McGill University Health Centre/Research Institute of the McGill University Health CentreUniversity, hospital or other
- Study start
- Aug 2008
- Primary completion
- Aug 2011 (actual)
- Study completion
- Aug 2011 (actual)
- First posted
- 20 Aug 2008 (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.
Endometrial sampling improves the pregnancy rates in superovulation-IUI cycles
Detailed description
Endometrial sampling is performed using the standard technique in the outpatient department. Similarly, superovulation with gonadotrophins will be performed according to our standard practice.Endometrial sampling will be done in the follicular phase not later than day 10 of the cycle. Endometrial sampling will be performed using Pipelle sampling catheter. The Pipelle is inserted gently through the cervical canal into the uterine cavity and advanced slowly till just resistance felt by the operator. Then, the piston is withdrawn to create negative suction and gentle movement of Pipelle up and down in the uterine cavity is performed while it is against the uterine wall. The Pipelle catheter is withdrawn gently and any obtained specimen will be sent for histopathological examination.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | No intervention | –Group 1 patients will receive standard superovulation-IUI treatment without endometrial sampling |
| 2 | Active comparator | Procedure: Endometrial samplingGroup 2 patients will receive standard superovulation-IUI treatment with endometrial sampling performed in the preceding cycle. It will be done in the follicular phase not later than day 10 of the cycle |
Who may qualify
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (3 listed)
- All women undergoing superovulation with gonadotrophins and intrauterine insemination.
- All women with cervical factor, mild male factor and/or unexplained infertility.
- At least one patent Fallopian tube.
Key exclusion criteria (4 listed)
- Bilateral tubal disease
- Severe male factor infertility
- Intrauterine pathology (submucosal fibroid, endometrial polyp, adhesions)
- Women with positive cervical culture and/or acute vaginal infection
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 |
|---|---|---|
| Endometrial samplingAlso: Intrauterine insemination, Clinical pregnancy rateEndometrial sampling performed in the preceding cycle. It will be done in the follicular phase not later than day 10 of the cycle | Procedure or surgery | 2 |
Primary outcome
The rate of clinical pregnancy
Time frame: 24 months
Results and safety
The study was stopped early (reason given: Because very low number of patients were enrolled). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Apr 2012.
- Background: PubMed 17197286Raziel A, Schachter M, Strassburger D, Bern O, Ron-El R, Friedler S. Favorable influence of local injury to the endometrium in intracytoplasmic sperm injection patients with high-order implantation failure. Fertil Steril. 2007 Jan;87(1):198-201. doi: 10.1016/j.fertnstert.2006.05.062.
- Results publication: PubMed 12798877Barash A, Dekel N, Fieldust S, Segal I, Schechtman E, Granot I. Local injury to the endometrium doubles the incidence of successful pregnancies in patients undergoing in vitro fertilization. Fertil Steril. 2003 Jun;79(6):1317-22. doi: 10.1016/s0015-0282(03)00345-5.
Related trials for Infertility
RecruitingObservational study
International Pilot Study for Dual Non-invasive Assesment of Embryo Development
Infertility
Active, not recruitingObservational study
Retrieval of Sperm From Men With Azoospermia Using Ultrasound-guided Rete Testis Aspiration
Azoospermia, Nonobstructive, Infertility, Male
Not yet recruiting
Spinery Basivertebral Nerve Ablation for Vertebrogenic Chronic Low Back Pain
Low Back Pain, Chronic Low Back Pain (CLBP)
RecruitingObservational study
Impact of Infertility on the Sexual Sphere in Couples Undergoing Assisted Reproduction
Sexual Health Quality of Life, Infertile Patients
RecruitingObservational study
Pilot Study of Discarded Blastocysts
Infertility (IVF Patients)
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.
Togas Tulandi, MD, MHCM principal investigator
McGill University Health Centre/Research Institute of the McGill University Health Centre
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Endometrial sampling in people with Infertility and Clinical Pregnancy Rate, 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 3 inclusion and 4 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 20 Apr 2012. 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: Because very low number of patients were enrolled). 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?
The rate of clinical pregnancy (time frame: 24 months). 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 NCT00737984, which also lists 2 linked publications.
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 20 Apr 2012.