InfertilityNCT02153814
Endometrial Injury and in Vitro Fertilization Outcomes
A study testing Endometrial Scratch in people with Infertility, run by Northwestern University at 1 site in United States.
Trial summary
Infertility affects 1 in 7 couples worldwide. The most successful treatment is in vitro fertilization (IVF), a procedure where a woman's eggs are collected and fertilized with sperm to make embryos, which are then placed in the woman's uterus using a small catheter, a procedure called "embryo transfer." Unfortunately… Read more about this study
- Who is it for?
- Ages 18 to 45 years, women only
- Conditions the study is for
- Infertility
- What is being tested?
- Endometrial Scratch
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 600 participants
- Where
- 1 siteUnited States
- Study dates
- Aug 2014to Dec 2018
- 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 45 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- Women undergoing IVF at the Northwestern Medical Faculty Foundation, Division of Reproductive Endocrinology and Infertility
- Age at time of egg retrieval 18-40 years, inclusive. Age at time of embryo transfer 18-45 years, inclusive.
- All subjects must have given signed, informed consent prior to registration in study
Who cannot join
- Patients with any current uterine pathology known to affect implantation, such as large hydrosalpinx, Asherman's syndrome, fibroids or polyps
- Patients with active cervical or pelvic infection
- Pregnant women
- Patients with a serious bleeding diathesis (e.g. hemophilia)
Trial locations and contacts
1 site in 1 country.
United States1 site
Northwestern Medical Faculty Foundation, Division of Reproductive Endocrinology and Infertility
Chicago, Illinois, 60611
About this study
Official title: Pilot Study on the Effect of Endometrial Injury in Patients Undergoing in Vitro Fertilization (IVF)
Infertility affects 1 in 7 couples worldwide. The most successful treatment is in vitro fertilization (IVF), a procedure where a woman's eggs are collected and fertilized with sperm to make embryos, which are then placed in the woman's uterus using a small catheter, a procedure called "embryo transfer." Unfortunately, pregnancy rates from IVF are less than 50%. Recently, several studies have shown dramatically improved pregnancy rates by grazing the innermost lining of the uterus (the endometrium) with a small flexible catheter weeks prior to embryo transfer. These studies were all performed outside the United States (U.S.) in women with multiple failed IVF attempts and did not investigate the mechanisms by which endometrial injury works. This study will be the first to evaluate the effect of endometrial injury on IVF success in all women undergoing IVF, including first IVF cycles, frozen embryo transfers, and donor eggs.
Read the detailed description
Nationally, the percentage of in vitro fertilization (IVF) cycles resulting in pregnancy is still less than 50%, even in optimal patients. While failed implantation may be due to embryo factors, in recent years much attention has been given to the role of endometrial receptivity at the time of embryo transfer. There is abundant evidence in the literature showing that, in women with repeated implantation failures despite having high quality embryos, endometrial injury performed either in the follicular phase of the IVF cycle or late in the cycle preceding the treatment cycle increases IVF success rates, often more than doubling the pregnancy rate.
The mechanism of improved pregnancy rates after endometrial injury is currently unknown. There is a paucity of studies in the current literature linking the biochemical and genetic changes induced by endometrial injury to pregnancy rates in patients undergoing IVF, as well as studies examining the effect of endometrial injury on ultrasound findings previously shown to predict IVF success, such as endometrial thickness, pattern, and volume, or markers of endometrial vascularity.
Additionally, no studies have been published examining whether or not IVF success rates can be improved in all-comers (not just women with repeated failures or abnormal appearing endometrium on ultrasound) by performing endometrial injury and there are currently no studies published on this topic with U.S. women in the study population. The proposed study would be the first to examine the effect of endometrial injury in U.S. women undergoing infertility treatment with IVF, regardless of prior treatment history, including women undergoing donor oocyte IVF cycles or frozen embryo transfer. It would also be the first to evaluate the biochemical changes induced by endometrial injury in the context of cycle outcome and live birth rate and to examine the effect on ultrasound parameters.
- Conditions
- Infertility
- Being tested
- Endometrial Scratch, Sham procedure
- Keywords
- Infertility, In vitro fertilization, Endometrial injury
- Medical subject headings
- Infertility
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Endometrial ScratchProcedure or surgery
Also called Endometrial biopsy, Endometrial injury, Endometrial pipelle
After cleansing the cervix with Betadine, the procedure will be performed using a 3mm endometrial sampling curette, with three passes made of the endometrium along the length of the fundus. Patients will be given the option to take ibuprofen 600mg one hour prior to the scheduled procedure. The first endometrial scratch procedure or sham procedure will be performed up to two weeks prior to expected menses, and the second endometrial scratch or sham procedure will be performed cycle day 5-11 of the stimulation cycle.
Sham procedureProcedure or surgery
For the sham procedure, after cleansing the cervix with betadine, the endometrial sampling curette will be placed 2-3cm into the cervix without entering the uterine cavity
| Study group | Role | What they receive |
|---|---|---|
| Control | Sham comparator | Will undergo sham procedure twice Receives: Procedure: Sham procedure |
| One Endometrial Scratch Procedure | Experimental | Will undergo one sham procedure and one endometrial scratch procedure Receives: Procedure: Endometrial Scratch |
| Two Endometrial Scratch Procedures | Experimental | Will undergo endometrial scratch procedure twice Receives: Procedure: Endometrial Scratch |
What is being measured
The primary outcome is the main question the study is designed to answer.
Live Birth Rate
Measured: 10 Months
Secondary outcomes (5)
Pregnancy Rate
Measured: 2 months
Implantation Rate
Measured: 1 month
Spontaneous Abortion Rate
Measured: 4 months
3-D Ultrasound Results - endometrial volume in mm^3
Measured: 1 month
Endometrial tissue gene expression levels (CT values)
Measured: 1 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Jun 2014 (estimated)
- Study startAug 2014
- Primary completionJun 2017
- Study completionDec 2018
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 Northwestern UniversityThe 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
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 600 participants (actual)
Sponsor and investigators
- Lead sponsor
- Northwestern University
- Sponsor type
- University, hospital or other
- Collaborators
- Northwestern Memorial Hospital
- Responsible party
- Sponsor
- Investigators
- Erica E Marsh, MD, MSCI, Principal investigator, Northwestern UniversityMolly B Moravek, MD, MPH, Study director, Northwestern UniversityRandall Barnes, MD, Principal investigator, Northwestern University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02153814
- Sponsor's protocol ID
- NW-STU00075489
- Status last verified
- May 2023
- First submitted
- 17 Dec 2013
- Last updated
- 3 May 2023
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 May 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pilot Study on the Effect of Endometrial Injury in Patients Undergoing in Vitro Fertilization (IVF)
- ClinicalTrials.gov ID
- NCT02153814
- Acronym / sponsor ID
- NW-STU00075489
- Conditions
- Infertility
- Keywords
- Infertility, In vitro fertilization, Endometrial injury
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 600 participants (actual)
- Lead sponsor
- Northwestern UniversityUniversity, hospital or other
- Collaborators
- Northwestern Memorial Hospital
- Study start
- Aug 2014
- Primary completion
- Jun 2017 (actual)
- Study completion
- Dec 2018 (actual)
- First posted
- 3 Jun 2014 (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.
Infertility affects 1 in 7 couples worldwide. The most successful treatment is in vitro fertilization (IVF), a procedure where a woman's eggs are collected and fertilized with sperm to make embryos, which are then placed in the woman's uterus using a small catheter, a procedure called "embryo transfer." Unfortunately, pregnancy rates from IVF are less than 50%. Recently, several studies have shown dramatically improved pregnancy rates by grazing the innermost lining of the uterus (the endometrium) with a small flexible catheter weeks prior to embryo transfer. These studies were all performed outside the United States (U.S.) in women with multiple failed IVF attempts and did not investigate the mechanisms by which endometrial injury works. This study will be the first to evaluate the effect of endometrial injury on IVF success in all women undergoing IVF, including first IVF cycles, frozen embryo transfers, and donor eggs.
Detailed description
Nationally, the percentage of in vitro fertilization (IVF) cycles resulting in pregnancy is still less than 50%, even in optimal patients. While failed implantation may be due to embryo factors, in recent years much attention has been given to the role of endometrial receptivity at the time of embryo transfer. There is abundant evidence in the literature showing that, in women with repeated implantation failures despite having high quality embryos, endometrial injury performed either in the follicular phase of the IVF cycle or late in the cycle preceding the treatment cycle increases IVF success rates, often more than doubling the pregnancy rate.
The mechanism of improved pregnancy rates after endometrial injury is currently unknown. There is a paucity of studies in the current literature linking the biochemical and genetic changes induced by endometrial injury to pregnancy rates in patients undergoing IVF, as well as studies examining the effect of endometrial injury on ultrasound findings previously shown to predict IVF success, such as endometrial thickness, pattern, and volume, or markers of endometrial vascularity.
Additionally, no studies have been published examining whether or not IVF success rates can be improved in all-comers (not just women with repeated failures or abnormal appearing endometrium on ultrasound) by performing endometrial injury and there are currently no studies published on this topic with U.S. women in the study population. The proposed study would be the first to examine the effect of endometrial injury in U.S. women undergoing infertility treatment with IVF, regardless of prior treatment history, including women undergoing donor oocyte IVF cycles or frozen embryo transfer. It would also be the first to evaluate the biochemical changes induced by endometrial injury in the context of cycle outcome and live birth rate and to examine the effect on ultrasound parameters.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Control | Sham comparator | Procedure: Sham procedureWill undergo sham procedure twice |
| One Endometrial Scratch Procedure | Experimental | Procedure: Endometrial ScratchWill undergo one sham procedure and one endometrial scratch procedure |
| Two Endometrial Scratch Procedures | Experimental | Procedure: Endometrial ScratchWill undergo endometrial scratch procedure twice |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Women undergoing IVF at the Northwestern Medical Faculty Foundation, Division of Reproductive Endocrinology and Infertility
- Age at time of egg retrieval 18-40 years, inclusive. Age at time of embryo transfer 18-45 years, inclusive.
- All subjects must have given signed, informed consent prior to registration in study
Key exclusion criteria (4 listed)
- Patients with any current uterine pathology known to affect implantation, such as large hydrosalpinx, Asherman's syndrome, fibroids or polyps
- Patients with active cervical or pelvic infection
- Pregnant women
- Patients with a serious bleeding diathesis (e.g. hemophilia)
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 ScratchAlso: Endometrial biopsy, Endometrial injury, Endometrial pipelleAfter cleansing the cervix with Betadine, the procedure will be performed using a 3mm endometrial sampling curette, with three passes made of the endometrium along the length of the fundus. Patients will be given the option to take ibuprofen 600mg one hour prior to the scheduled procedure. The first endometrial scratch procedure or sham procedure will be performed up to two weeks prior to expected menses, and the second endometrial scratch or sham procedure will be performed cycle day 5-11 of the stimulation cycle. | Procedure or surgery | One Endometrial Scratch Procedure, Two Endometrial Scratch Procedures |
| Sham procedureFor the sham procedure, after cleansing the cervix with betadine, the endometrial sampling curette will be placed 2-3cm into the cervix without entering the uterine cavity | Procedure or surgery | Control |
Primary outcome
Live Birth Rate
Time frame: 10 Months
5 secondary outcomes
Pregnancy Rate
Time frame: 2 months
Implantation Rate
Time frame: 1 month
Spontaneous Abortion Rate
Time frame: 4 months
3-D Ultrasound Results - endometrial volume in mm^3
Time frame: 1 month
Endometrial tissue gene expression levels (CT values)
Time frame: 1 month
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 May 2023.
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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.
Erica E Marsh, MD, MSCI principal investigator
Northwestern University
Molly B Moravek, MD, MPH study director
Northwestern University
Randall Barnes, MD principal investigator
Northwestern University
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 Scratch in people with Infertility, run by Northwestern University at 1 site in United States.
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: finished, as of the sponsor's last update on 3 May 2023. 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 United States. 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. Some participants in this study may receive a placebo. 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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Live Birth Rate (time frame: 10 Months). 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 3 May 2023.