Infertility, FemaleNCT05397912
Uterine Elastography: a Potential Predictor of Embryo Transfer Success
An observational study of Infertility, Female, run by Reproductive Medicine Associates of New Jersey at 1 site in United States.
Trial summary
To determine if the mean elasticity value (measured in kilopascals, kPa) of a patient's endometrium, myometrium and cervix in a sonographically normal appearing uterus predict frozen embryo transfer (FET) success and long term reproductive outcomes when measured the day prior to FET. Read more about this study
- Who is it for?
- Ages 18 to 45 years, women only
- Conditions the study is for
- Infertility, Female
- What is being tested?
- Uterine Elastography
- How many people
- 162 participants
- Where
- 1 siteUnited States
- Study dates
- 15 Jun 2022to 1 Sep 2023
- Phase
- Observational
- 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
Study population: All patients presenting to one of our offices for an ultrasound the day prior to embryo transfer will be reviewed for inclusion. Patients will be undergoing euploid, single, frozen embryo transfer.
Who may be able to join
- Female patients, 18yo-45yo, presenting for ultrasound the day prior to embryo transfer
- Patients planning to undergo single embryo transfer (SET) of a euploid embryo by Preimplantation genetic testing for aneuploidy (PGT-A)
- Uterine evaluation prior to transfer (saline sonogram or hysteroscopy) within 1 year
- Egg recipients
Who cannot join
- Gestational carriers
- BMI > 35
- Diagnosis of a uterine anomaly
- History of uterine surgery, excluding polypectomy, c-section, D\&C
- Communicating hydrosalpinx
- Transfer of an embryo of unknown ploidy status or embryos of undetermined safety
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- Surgically retrieved sperm
- Embryos that were cryopreserved on day 7 of development
- Poor quality embryos defined by modified Gardner grading criteria used in the embryology lab
- Sonographically abnormal appearing uteri, including distortions from leiomyomas and thin endometrium
Trial locations and contacts
1 site in 1 country.
United States1 site
Reproductive Medicine Associates of New Jersey
Basking Ridge, New Jersey, 07920
About this study
To determine if the mean elasticity value (measured in kilopascals, kPa) of a patient's endometrium, myometrium and cervix in a sonographically normal appearing uterus predict frozen embryo transfer (FET) success and long term reproductive outcomes when measured the day prior to FET.
- Conditions
- Infertility, Female
- Being tested
- Uterine Elastography
- Medical subject headings
- Infertility, Female
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Uterine ElastographyDiagnostic test
Shear wave elastography data will be obtained at the transvaginal ultrasound visit the day prior to frozen embryo transfer
| Study group | Role | What they receive |
|---|---|---|
| Women undergoing euploid, single frozen embryo transfer | Women age 18yo-45yo undergoing euploid, single, frozen embryo transfer with sonographically normal appearing uterus without uterine factor infertility Receives: Diagnostic Test: Uterine Elastography |
What is being measured
The primary outcome is the main question the study is designed to answer.
Sustained Implantation Rate
number of fetal heart beats at time of discharge ultrasound
Measured: 6 weeks after embryo transfer
Secondary outcomes (3)
Chemical Pregnancy
Positive serum bHCG level
Measured: 8-10 days after embryo transfer
Clinical Pregnancy
presence of gestational sac on ultrasound
Measured: 2-4 weeks after embryo transfer
Clinical Pregnancy Loss
loss of gestational sac, yolk sac, fetal pole, fetal heart beat on ultrasound after being present
Measured: 2-40 weeks after embryo transfer
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 May 2022
- Study start15 Jun 2022
- Primary completion12 Jan 2023
- Study completion1 Sep 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Infertility, FemaleStudies 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 162 participants (actual)
Sponsor and investigators
- Lead sponsor
- Reproductive Medicine Associates of New Jersey
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Marie Werner, MD, Principal investigator, Reproductive Medicine Associates of New Jersey
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05397912
- Sponsor's protocol ID
- RMA-2022-02
- Status last verified
- Feb 2025
- First submitted
- 25 May 2022
- Last updated
- 7 Feb 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Margolis C, Garrido N, Roberts L, Reig A, Gill P, Willson S, Genovese H, Barrett F, Zuckerman C, Whitehead C, Bergh P, Seli E, Werner M. Mapping the way to successful euploid frozen embryo transfer: a prospective pilot study of uterine elastography. Hum Reprod. 2025 May 1;40(5):895-903. doi: 10.1093/humrep/deaf029.
PubMed 39999405
Study at a glance
From the registry record, last updated by the sponsor on 7 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Uterine Elastography: a Potential Predictor of Embryo Transfer Success
- ClinicalTrials.gov ID
- NCT05397912
- Acronym / sponsor ID
- RMA-2022-02
- Conditions
- Infertility, Female
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 162 participants (actual)
- Lead sponsor
- Reproductive Medicine Associates of New JerseyUniversity, hospital or other
- Study start
- 15 Jun 2022 (actual)
- Primary completion
- 12 Jan 2023 (actual)
- Study completion
- 1 Sep 2023 (actual)
- First posted
- 31 May 2022 (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.
To determine if the mean elasticity value (measured in kilopascals, kPa) of a patient's endometrium, myometrium and cervix in a sonographically normal appearing uterus predict frozen embryo transfer (FET) success and long term reproductive outcomes when measured the day prior to FET.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Women undergoing euploid, single frozen embryo transfer | – | Diagnostic Test: Uterine ElastographyWomen age 18yo-45yo undergoing euploid, single, frozen embryo transfer with sonographically normal appearing uterus without uterine factor infertility |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
- Study population
- All patients presenting to one of our offices for an ultrasound the day prior to embryo transfer will be reviewed for inclusion. Patients will be undergoing euploid, single, frozen embryo transfer.
Key inclusion criteria (4 listed)
- Female patients, 18yo-45yo, presenting for ultrasound the day prior to embryo transfer
- Patients planning to undergo single embryo transfer (SET) of a euploid embryo by Preimplantation genetic testing for aneuploidy (PGT-A)
- Uterine evaluation prior to transfer (saline sonogram or hysteroscopy) within 1 year
- Egg recipients
Key exclusion criteria (10 listed)
- Gestational carriers
- BMI > 35
- Diagnosis of a uterine anomaly
- History of uterine surgery, excluding polypectomy, c-section, D\&C
- Communicating hydrosalpinx
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 |
|---|---|---|
| Uterine ElastographyShear wave elastography data will be obtained at the transvaginal ultrasound visit the day prior to frozen embryo transfer | Diagnostic test | Women undergoing euploid, single frozen embryo transfer |
Primary outcome
Sustained Implantation Rate
Time frame: 6 weeks after embryo transfer
number of fetal heart beats at time of discharge ultrasound
3 secondary outcomes
Chemical Pregnancy
Time frame: 8-10 days after embryo transfer
Clinical Pregnancy
Time frame: 2-4 weeks after embryo transfer
Clinical Pregnancy Loss
Time frame: 2-40 weeks after embryo transfer
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 7 Feb 2025.
- Derived from this study: PubMed 39999405Margolis C, Garrido N, Roberts L, Reig A, Gill P, Willson S, Genovese H, Barrett F, Zuckerman C, Whitehead C, Bergh P, Seli E, Werner M. Mapping the way to successful euploid frozen embryo transfer: a prospective pilot study of uterine elastography. Hum Reprod. 2025 May 1;40(5):895-903. doi: 10.1093/humrep/deaf029.
- Individual participant dataSharing planned: No
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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.
Marie Werner, MD principal investigator
Reproductive Medicine Associates of New Jersey
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Infertility, Female, run by Reproductive Medicine Associates of New Jersey 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 4 inclusion and 10 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 7 Feb 2025. 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. 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?
Sustained Implantation Rate (time frame: 6 weeks after embryo transfer). 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 NCT05397912, which also lists 1 linked publication.
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 7 Feb 2025.