Recurrent Implantation Failure in Setting of Artifically Prepared EndometriumNCT03157765
Trial of Endometrial Scratch Prior to Frozen Embryo Transfer in Patients With Recurrent Implantation Failure
A study testing endometrial biopsy in people with Recurrent Implantation Failure in Setting of Artifically Prepared Endometrium, run by Brown Fertility.
Trial summary
Patients with a history of recurrent implantation failure who are planning a frozen embryo transfer (FET) are enrolled into the program. Patients are randomized to an endometrial biopsy prior to starting estrogen to prepare for the transfer of warmed vitrified embryos or to routine care. Read more about this study
- Who is it for?
- Ages 18 to 49 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Recurrent Implantation Failure in Setting of Artifically Prepared Endometrium
- What is being tested?
- endometrial biopsy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- Jun 2017to Jun 2019
- 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 49 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- At least two prior consecutive failed IVF or FET cycles with transfer of at least 3 high quality embryos and with last cycle a FET cycle
Who cannot join
- Alternate explanation for implantation failure (e.g., intrauterine pathology)
About this study
Official title: A Randomized Study on the Value of an Endometrial Scratch Prior to a Frozen Embryo Transfer Cycle in the Treatment of Recurrent Implantation Failure
Patients with a history of recurrent implantation failure who are planning a frozen embryo transfer (FET) are enrolled into the program. Patients are randomized to an endometrial biopsy prior to starting estrogen to prepare for the transfer of warmed vitrified embryos or to routine care.
Read the detailed description
Patients who failed to achieve a clinical pregnancy after embryo transfer of at least three high quality embryos in at least two IVF or FET cycles and for whom their last failed cycle was a frozen embryo transfer are offered the opportunity to enroll in this study. All patients will follow our routine FET protocol.
On a randomized basis, selected patients will undergo an endometrial biopsy using a Pipelle disposable device in the week prior to starting estrogen to prepare her endometrium.
- Being tested
- endometrial biopsy
- Keywords
- recurrent implantation failure, frozen embryo transfer, IVF, endometrial scratch, endometrial injury
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
endometrial biopsyProcedure or surgery
endometrial biopsy
| Study group | Role | What they receive |
|---|---|---|
| EMB intervention | Experimental | These patients receive and endometrial biopsy Receives: Procedure: endometrial biopsy |
| Routine care | No intervention | These patient receive routine care |
What is being measured
The primary outcome is the main question the study is designed to answer.
Implantation rate
Sacs seen in early ultrasound divided by the number of embryos transferred
Measured: within 6 months after recruitment
clinical pregnancy rate
Number of patients with ultrasound evidence of pregnancy divided by the number of embryo transfers
Measured: within 6 months after recruitment
Secondary outcomes (3)
ongoing pregnancy rate
Viable or delivered pregnancies at conclusion of study divided by the number of embryo transfers
Measured: within 18 months of recruitment
biochemical pregnancy rate
number of positive pregnancy test divided by number of embryo transfers
Measured: within 6 months after recruitment
miscarriage rate
number of losses of clinical pregnancies divided by number of clinical pregnancies
Measured: within 18 months after recruitment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 May 2017
- Study startJun 2017 (estimated)
- Primary completionJun 2019 (estimated)
- Study completionJun 2019 (estimated)
Why it stopped: Change in research site
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Recurrent Implantation Failure in Setting of Artifically Prepared EndometriumStudies 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
- Single group
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Brown Fertility
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03157765
- Sponsor's protocol ID
- EMB for RIP/FET
- Status last verified
- Jan 2019
- First submitted
- 16 May 2017
- Last updated
- 23 Jan 2019
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Jan 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Study on the Value of an Endometrial Scratch Prior to a Frozen Embryo Transfer Cycle in the Treatment of Recurrent Implantation Failure
- ClinicalTrials.gov ID
- NCT03157765
- Acronym / sponsor ID
- EMB for RIP/FET
- Keywords
- recurrent implantation failure, frozen embryo transfer, IVF, endometrial scratch, endometrial injury
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Change in research site
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Brown FertilityUniversity, hospital or other
- Study start
- Jun 2017 (estimated)
- Primary completion
- Jun 2019 (estimated)
- Study completion
- Jun 2019 (estimated)
- First posted
- 17 May 2017 (actual)
- 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.
Patients with a history of recurrent implantation failure who are planning a frozen embryo transfer (FET) are enrolled into the program. Patients are randomized to an endometrial biopsy prior to starting estrogen to prepare for the transfer of warmed vitrified embryos or to routine care.
Detailed description
Patients who failed to achieve a clinical pregnancy after embryo transfer of at least three high quality embryos in at least two IVF or FET cycles and for whom their last failed cycle was a frozen embryo transfer are offered the opportunity to enroll in this study. All patients will follow our routine FET protocol.
On a randomized basis, selected patients will undergo an endometrial biopsy using a Pipelle disposable device in the week prior to starting estrogen to prepare her endometrium.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| EMB intervention | Experimental | Procedure: endometrial biopsyThese patients receive and endometrial biopsy |
| Routine care | No intervention | –These patient receive routine care |
Who may qualify
- Ages
- 18 to 49 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- At least two prior consecutive failed IVF or FET cycles with transfer of at least 3 high quality embryos and with last cycle a FET cycle
Key exclusion criteria (1 listed)
- Alternate explanation for implantation failure (e.g., intrauterine pathology)
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 biopsyendometrial biopsy | Procedure or surgery | EMB intervention |
Primary outcome
Implantation rate
Time frame: within 6 months after recruitment
Sacs seen in early ultrasound divided by the number of embryos transferred
clinical pregnancy rate
Time frame: within 6 months after recruitment
Number of patients with ultrasound evidence of pregnancy divided by the number of embryo transfers
3 secondary outcomes
ongoing pregnancy rate
Time frame: within 18 months of recruitment
biochemical pregnancy rate
Time frame: within 6 months after recruitment
miscarriage rate
Time frame: within 18 months after recruitment
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Jan 2019.
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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing endometrial biopsy in people with Recurrent Implantation Failure in Setting of Artifically Prepared Endometrium, run by Brown Fertility.
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 1 inclusion and 1 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: withdrawn, as of the sponsor's last update on 23 Jan 2019. Status can change between updates, so confirm with the study contact before making plans.
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 withdrawn before enrolling participants, so there are no results.
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?
Implantation rate (time frame: within 6 months after recruitment). The study lists 2 primary outcomes in all. 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 23 Jan 2019.