InfertilityNCT00411021
Endometrial Sampling (Pipelle)in IVF Patients
A study testing Pipelle (Endometrial Sampling) in people with Infertility, run by Sheba Medical Center at 1 site in Israel.
Trial summary
A prospective cross-over randomized study aimed to test the hypothesis that local injury of the endometrium increases the implantation rate in the successive cycle. Seventy IVF patients will be randomly selected to undergo either endometrial biopsies or minimal cervical scratch on days 8-10 and 21-23 of their cycle… Read more about this study
- Who is it for?
- Ages 20 to 45 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Infertility
- What is being tested?
- Pipelle (Endometrial Sampling)
- Type of treatment
- Surgery or procedure
- How many people
- 70 participants
- Where
- 1 siteIsrael
- Study dates
- Start not givento not given
- 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 20 to 45 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Women undergoing IVF treatment
- Repeated Implantation failure
Who cannot join
- PID or suspected PID
- Undiagnosed Irregular Bleeding
Trial locations and contacts
1 site in 1 country.
Micha Baum, MD contact
Israel1 site, 1 recruiting
- Recruiting
IVF Unit, Sheba Medical Center
Ramat Gan, 52621
Micha Baum, MD, baumdr@zahav.net.il
About this study
A prospective cross-over randomized study aimed to test the hypothesis that local injury of the endometrium increases the implantation rate in the successive cycle. Seventy IVF patients will be randomly selected to undergo either endometrial biopsies or minimal cervical scratch on days 8-10 and 21-23 of their cycle, preceding the IVF treatment. If not pregnant, the women will continue for another IVF cycle, preceded by endometrial or cervical scratch complimentary to their procedure in the first cycle. The main major outcomes will include pregnancy rate, implantation rate, endometrial thickness, abortion rate, live births and embryo quality.
- Conditions
- Infertility
- Being tested
- Pipelle (Endometrial Sampling)
- Medical subject headings
- Infertility
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Pipelle (Endometrial Sampling)Procedure or surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Dec 2006 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for InfertilityStudies of the same condition, open and under way.
- More trials run by Sheba Medical CenterThe 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
- Crossover
- Masking
- Single blind
- Enrolment
- 70 participants
Sponsor and investigators
- Lead sponsor
- Sheba Medical Center
- Sponsor type
- Other government
- Investigators
- Micha Baum, MD, Principal investigator, Sheba Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00411021
- Sponsor's protocol ID
- SHEBA-05-3674-MB-CTIL
- Status last verified
- Dec 2006
- First submitted
- 12 Dec 2006
- Last updated
- 13 Dec 2006
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Dec 2006. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Endometrial Sampling (Pipelle)in IVF Patients
- ClinicalTrials.gov ID
- NCT00411021
- Acronym / sponsor ID
- SHEBA-05-3674-MB-CTIL
- Conditions
- Infertility
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 70 participants
- Lead sponsor
- Sheba Medical CenterOther government
- First posted
- 13 Dec 2006 (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.
A prospective cross-over randomized study aimed to test the hypothesis that local injury of the endometrium increases the implantation rate in the successive cycle. Seventy IVF patients will be randomly selected to undergo either endometrial biopsies or minimal cervical scratch on days 8-10 and 21-23 of their cycle, preceding the IVF treatment. If not pregnant, the women will continue for another IVF cycle, preceded by endometrial or cervical scratch complimentary to their procedure in the first cycle. The main major outcomes will include pregnancy rate, implantation rate, endometrial thickness, abortion rate, live births and embryo quality.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind
Who may qualify
- Ages
- 20 to 45 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- Women undergoing IVF treatment
- Repeated Implantation failure
Key exclusion criteria (2 listed)
- PID or suspected PID
- Undiagnosed Irregular Bleeding
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 |
|---|---|---|
| Pipelle (Endometrial Sampling) | Procedure or surgery | – |
Primary outcome
Not reported in the source record.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Dec 2006.
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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.
Micha Baum, MD contact
Micha Baum, MD principal investigator
Sheba Medical 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 Pipelle (Endometrial Sampling) in people with Infertility, run by Sheba Medical Center at 1 site in Israel.
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 2 inclusion and 2 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: status not confirmed, as of the sponsor's last update on 13 Dec 2006. 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 Israel. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Micha Baum, MD (baumdr@zahav.net.il), or a site near the patient. AzTrials does not enrol participants or take referrals.
Where can I read the original study information?
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 13 Dec 2006.