InfertilityNCT01278706
Endometrial Biopsy Protocol for In Vitro Fertilization (IVF)
A study testing endometrial biopsy/ies in people with Infertility and Recurrent Implantation Failure, run by Kaplan Medical Center at 2 sites in Israel.
Trial summary
Endometrial biopsy has been shown to improve IVF pregnancy and live birth rates. The optimal time of performing the biopsy is yet to be established. In this study, the investigators will compare different temporal timing of the biopsies with regards to the menstrual cycle and their affect on the success rates of the… Read more about this study
- Who is it for?
- Ages 18 to 38 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Infertility, Recurrent Implantation Failure
- What is being tested?
- endometrial biopsy/ies
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 200 participants
- Where
- 2 sitesIsrael
- Study dates
- Jan 2011to Jan 2013
- 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 38 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- normal menstrual cycle
- between 1-6 previous failed IVF cycles
- normal hormonal profile
Who cannot join
- intrauterine procedure in last 3 months
- hydrosalpinx
- intrauterine lesion /malformation
Trial locations and contacts
2 sites in 1 country.
Israel2 sites
Kaplan Medical Center, IVF Unit
Rehovot
Levin, +972-8-9441623
Amihai Barash, M/D/
Weizmann Institute of Science
Rehovot
About this study
Official title: Comparing Timing and Number of Endometrial Biopsies in IVF Treatment and Identifying Biochemical Markers to Predict Endometrial Receptivity
Endometrial biopsy has been shown to improve IVF pregnancy and live birth rates. The optimal time of performing the biopsy is yet to be established.
In this study, the investigators will compare different temporal timing of the biopsies with regards to the menstrual cycle and their affect on the success rates of the treatment.
- Conditions
- Infertility, Recurrent Implantation Failure
- Being tested
- endometrial biopsy/ies
- Medical subject headings
- Infertility
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
endometrial biopsy/iesProcedure or surgery
performing office endometrial biopsy with a disposable sterile catheter
| Study group | Role | What they receive |
|---|---|---|
| no treatment | No intervention | Not described |
| one biopsy, proliferative phase | Experimental | Not described Receives: Procedure: endometrial biopsy/ies |
| one biopsy, secretory phase | Experimental | Not described Receives: Procedure: endometrial biopsy/ies |
| two biopsies | Experimental | Not described Receives: Procedure: endometrial biopsy/ies |
What is being measured
The primary outcome is the main question the study is designed to answer.
pregnancy rates
Measured: 2 years
Secondary outcomes (1)
live birth rates
Measured: 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Jan 2011 (estimated)
- Study startJan 2011
- Primary completionJan 2013 (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.
- 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
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Kaplan Medical Center
- Sponsor type
- University, hospital or other
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01278706
- Sponsor's protocol ID
- kmc110154CTIL
- Status last verified
- Dec 2010
- First submitted
- 18 Jan 2011
- Last updated
- 26 Jan 2011
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 26 Jan 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparing Timing and Number of Endometrial Biopsies in IVF Treatment and Identifying Biochemical Markers to Predict Endometrial Receptivity
- ClinicalTrials.gov ID
- NCT01278706
- Acronym / sponsor ID
- kmc110154CTIL
- Conditions
- Infertility, Recurrent Implantation Failure
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Kaplan Medical CenterUniversity, hospital or other
- Study start
- Jan 2011
- Primary completion
- Jan 2013 (estimated)
- First posted
- 19 Jan 2011 (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 biopsy has been shown to improve IVF pregnancy and live birth rates. The optimal time of performing the biopsy is yet to be established.
In this study, the investigators will compare different temporal timing of the biopsies with regards to the menstrual cycle and their affect on the success rates of the treatment.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| no treatment | No intervention | – |
| one biopsy, proliferative phase | Experimental | Procedure: endometrial biopsy/ies |
| one biopsy, secretory phase | Experimental | Procedure: endometrial biopsy/ies |
| two biopsies | Experimental | Procedure: endometrial biopsy/ies |
Who may qualify
- Ages
- 18 to 38 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- normal menstrual cycle
- between 1-6 previous failed IVF cycles
- normal hormonal profile
Key exclusion criteria (3 listed)
- intrauterine procedure in last 3 months
- hydrosalpinx
- intrauterine lesion /malformation
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 biopsy/iesperforming office endometrial biopsy with a disposable sterile catheter | Procedure or surgery | one biopsy, proliferative phase, one biopsy, secretory phase, two biopsies |
Primary outcome
pregnancy rates
Time frame: 2 years
1 secondary outcome
live birth rates
Time frame: 3 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Jan 2011.
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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.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing endometrial biopsy/ies in people with Infertility and Recurrent Implantation Failure, run by Kaplan Medical Center at 2 sites 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 3 inclusion and 3 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 26 Jan 2011. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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 Dan Levin, M.D. (+972-89441623, dan_l@clalit.org.il), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
pregnancy rates (time frame: 2 years). It is what the study was designed to measure, not a finding.
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 26 Jan 2011; AzTrials last refreshed its copy on 1 Nov 2026.