Infertility, FemaleNCT04330066
Impact of Endometrial Compaction in Euploid Frozen Embryo Transfers
An observational study of Infertility, Female, run by Boston IVF at 1 site in United States.
Trial summary
The purpose of this pilot study is to evaluate whether a decrease in endometrial thickness (compaction) prior to progesterone exposure (endogenous or exogenous) to the day before a single frozen embryo transfer has an impact on the clinical pregnancy rate with euploid embryos in exogenous hormone and modified natural… Read more about this study
- Who is it for?
- Ages 18 to 44 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Infertility, Female
- What is being tested?
- Abdominal ultrasound measurement of the endometrial lining
- Type of treatment
- Pill or oral medicine, Injection or infusion
- How many people
- 187 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Sep 2020to 30 Jun 2022
- 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 44 years
- Women only
- Healthy volunteers accepted
- Adult
Study population: Participants that are having a single frozen embryo transfer with a euploid embryo.
Who may be able to join
- Single euploid frozen embryo transfer
- ≥ 7 mm endometrial lining on transvaginal ultrasound
- 1st or 2nd frozen embryo transfer
Who cannot join
- Obesity with body mass index > 40
- Underweight with body mass index < 18.5
- Utilization of a gestational carrier
- History of recurrent pregnancy loss (≥ 2 spontaneous abortions)
- Uterine factors (history of uterine adhesions, uterine surgery, fibroids, polyps)
- History of an endometrial receptivity assay (ERA) biopsy
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Impact of Endometrial Compaction in Euploid Frozen Embryo Transfers: a Prospective Observational Pilot Study
The purpose of this pilot study is to evaluate whether a decrease in endometrial thickness (compaction) prior to progesterone exposure (endogenous or exogenous) to the day before a single frozen embryo transfer has an impact on the clinical pregnancy rate with euploid embryos in exogenous hormone and modified natural thaw cycles. Information derived from this study may give insight on ways to improve pregnancy rates in cryo-thaw cycles.
Read the detailed description
Methods: Study participation will not influence any element of IVF treatment and all participants will be receiving the standard of care at Boston IVF. Potential participants will be identified by a member of the research team, who will review the appointment log and medical records to ensure eligibility. Eligible participants interested in participating in the study will have an abdominal ultrasound endometrial thickness measurement on the day of the participants embryo transfer (T2). This abdominal ultrasound is part of routine clinical care necessary for the embryo transfer. The eligible participant will provide verbal consent to a member of the research team prior to the ultrasound. Baseline demographic data will be obtained from the electronic medical record including: age, race, education level, partner status, height, weight, gravidity, and parity.
Two groups of thaw cycles will be included: (1) exogenous hormone replacement thaw cycles and (2) modified natural thaw cycle. Both groups will follow the standard of care for cycle preparation at Boston IVF. Ultrasound measurements of the endometrial lining (T1) will only be used if they were within 1 day of the initiation of progesterone (group 1) or ovulation trigger injection (group 2). At T1, multiple endometrial lining measurements will be made per standard protocol, but only the optimal image and measurement will be saved. At T2, only a single endometrial thickness measurement will be measured by the sonographer and will be recorded on a study log. Images should include a longitudinal view of the endometrium and cervix. Measurements from the T2 ultrasound will be blinded from the participant and they will not be used to make any clinical decisions. Both groups will have a comparison of the difference in endometrial thickness measurement between T1 and T2.
Sample Size Justification: Given the limited data on this specific topic, the study will be an observational pilot study. Given the available resources, the researchers will aim to have 100 participants per cycle preparation group, for a total of 200 participants.
Data Analysis: Descriptive data will be presented as the proportion, mean with standard deviation, or median with interquartile range. Comparisons will be made using the chi-square or Fisher's exact test for categorical variables and parametric or non-parametric tests for continuous variables based on data distribution. Logistic regression analysis will be performed for multivariate analysis. All data will be analyzed with SAS 9.4 (SAS Institute Inc., Cary, NC, USA). All tests will be two sided and a P value < 0.05 will be required to confer significance.
- Conditions
- Infertility, Female
- Being tested
- Abdominal ultrasound measurement of the endometrial lining
- Keywords
- endometrial compaction, frozen embryo transfer, euploid embryo, ultrasound
- Medical subject headings
- Infertility, Female
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Abdominal ultrasound measurement of the endometrial liningDiagnostic test
On the day of the participants frozen embryo transfer, an endometrial thickness measurement (T2) will obtained from an abdominal ultrasound during the embryo transfer.
| Study group | Role | What they receive |
|---|---|---|
| Exogenous hormone replacement thaw cycle | Participants in this group will follow Boston IVF's standard exogenous hormone replacement protocol. Participants will take Estrace 3mg twice daily by mouth for endometrial preparation. After 16-18 days of Estrace, endometrial thickness will be measured by transvaginal ultrasound but medication and ultrasounds will be continued until the endometrial lining is ≥ 7 mm. Once the final endometrial lining is ≥ 7 mm (T1), the doctor of record will start the participant the following day with intramuscular progesterone daily or intramuscular progesterone every 3 days with daily vaginal progesterone. Frozen embryo transfers would occur on the sixth day of progesterone. Receives: Diagnostic Test: Abdominal ultrasound measurement of the endometrial lining | |
| Natural thaw cycle | Participants in this group will follow Boston IVF's standard natural thaw cycle protocol. Participants will be coming for blood and transvaginal ultrasound monitoring around day 11 of the participants cycle. Once the participant has a final measurement of the endometrial lining ≥ 7 mm (T1), a 17mm ovarian follicle, and a progesterone < 1.2 ng/mL, the doctor of record will schedule the patient to receive a trigger injection to induce ovulation followed by an embryo transfer 6-7 days later. Participants may be started on vaginal progesterone 4 days after the trigger injection for added supplementation per the doctor of record. Receives: Diagnostic Test: Abdominal ultrasound measurement of the endometrial lining |
What is being measured
The primary outcome is the main question the study is designed to answer.
Clinical pregnancy rate
defined as confirmation of gestational sac with fetal heart beat on ultrasound between 6 - 9 weeks gestation
Measured: through study completion, an average of 1 year
Secondary outcomes (3)
Biochemical pregnancy rate
defined as positive beta-hCG but no gestational sac visualized
Measured: through study completion, an average of 1 year
Live birth rate
defined as delivery > 23 weeks gestation
Measured: through study completion, an average of 1 year
Miscarriage rate
defined as the loss of a pregnancy prior to 12 weeks per total number of pregnancies
Measured: through study completion, an average of 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Apr 2020
- Study start1 Sep 2020
- Primary completion30 May 2022 (estimated)
- Study completion30 Jun 2022 (estimated)
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
- 187 participants (actual)
Sponsor and investigators
- Lead sponsor
- Boston IVF
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Alan Penzias, MD, Principal investigator, Boston IVF
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04330066
- Sponsor's protocol ID
- 2020P000191
- Status last verified
- Mar 2022
- First submitted
- 30 Mar 2020
- Last updated
- 11 Mar 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Shah JS, Vaughan DA, Dodge LE, Leung A, Korkidakis A, Sakkas D, Ryley DA, Penzias AS, Toth TL. Endometrial compaction does not predict live birth in single euploid frozen embryo transfers: a prospective study. Hum Reprod. 2022 May 3;37(5):980-987. doi: 10.1093/humrep/deac060.
PubMed 35357436
Study at a glance
From the registry record, last updated by the sponsor on 11 Mar 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of Endometrial Compaction in Euploid Frozen Embryo Transfers: a Prospective Observational Pilot Study
- ClinicalTrials.gov ID
- NCT04330066
- Acronym / sponsor ID
- 2020P000191
- Conditions
- Infertility, Female
- Keywords
- endometrial compaction, frozen embryo transfer, euploid embryo, ultrasound
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 187 participants (actual)
- Lead sponsor
- Boston IVFUniversity, hospital or other
- Study start
- 1 Sep 2020 (actual)
- Primary completion
- 30 May 2022 (estimated)
- Study completion
- 30 Jun 2022 (estimated)
- First posted
- 1 Apr 2020 (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.
The purpose of this pilot study is to evaluate whether a decrease in endometrial thickness (compaction) prior to progesterone exposure (endogenous or exogenous) to the day before a single frozen embryo transfer has an impact on the clinical pregnancy rate with euploid embryos in exogenous hormone and modified natural thaw cycles. Information derived from this study may give insight on ways to improve pregnancy rates in cryo-thaw cycles.
Detailed description
Methods: Study participation will not influence any element of IVF treatment and all participants will be receiving the standard of care at Boston IVF. Potential participants will be identified by a member of the research team, who will review the appointment log and medical records to ensure eligibility. Eligible participants interested in participating in the study will have an abdominal ultrasound endometrial thickness measurement on the day of the participants embryo transfer (T2). This abdominal ultrasound is part of routine clinical care necessary for the embryo transfer. The eligible participant will provide verbal consent to a member of the research team prior to the ultrasound. Baseline demographic data will be obtained from the electronic medical record including: age, race, education level, partner status, height, weight, gravidity, and parity.
Two groups of thaw cycles will be included: (1) exogenous hormone replacement thaw cycles and (2) modified natural thaw cycle. Both groups will follow the standard of care for cycle preparation at Boston IVF. Ultrasound measurements of the endometrial lining (T1) will only be used if they were within 1 day of the initiation of progesterone (group 1) or ovulation trigger injection (group 2). At T1, multiple endometrial lining measurements will be made per standard protocol, but only the optimal image and measurement will be saved. At T2, only a single endometrial thickness measurement will be measured by the sonographer and will be recorded on a study log. Images should include a longitudinal view of the endometrium and cervix. Measurements from the T2 ultrasound will be blinded from the participant and they will not be used to make any clinical decisions. Both groups will have a comparison of the difference in endometrial thickness measurement between T1 and T2.
Sample Size Justification: Given the limited data on this specific topic, the study will be an observational pilot study. Given the available resources, the researchers will aim to have 100 participants per cycle preparation group, for a total of 200 participants.
Data Analysis: Descriptive data will be presented as the proportion, mean with standard deviation, or median with interquartile range. Comparisons will be made using the chi-square or Fisher's exact test for categorical variables and parametric or non-parametric tests for continuous variables based on data distribution. Logistic regression analysis will be performed for multivariate analysis. All data will be analyzed with SAS 9.4 (SAS Institute Inc., Cary, NC, USA). All tests will be two sided and a P value < 0.05 will be required to confer significance.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Exogenous hormone replacement thaw cycle | – | Diagnostic Test: Abdominal ultrasound measurement of the endometrial liningParticipants in this group will follow Boston IVF's standard exogenous hormone replacement protocol. Participants will take Estrace 3mg twice daily by mouth for endometrial preparation. After 16-18 days of Estrace, endometrial thickness will be measured by transvaginal ultrasound but medication and ultrasounds will be continued until the endometrial lining is ≥ 7 mm. Once the final endometrial lining is ≥ 7 mm (T1), the doctor of record will start the participant the following day with intramuscular progesterone daily or intramuscular progesterone every 3 days with daily vaginal progesterone. Frozen embryo transfers would occur on the sixth day of progesterone. |
| Natural thaw cycle | – | Diagnostic Test: Abdominal ultrasound measurement of the endometrial liningParticipants in this group will follow Boston IVF's standard natural thaw cycle protocol. Participants will be coming for blood and transvaginal ultrasound monitoring around day 11 of the participants cycle. Once the participant has a final measurement of the endometrial lining ≥ 7 mm (T1), a 17mm ovarian follicle, and a progesterone < 1.2 ng/mL, the doctor of record will schedule the patient to receive a trigger injection to induce ovulation followed by an embryo transfer 6-7 days later. Participants may be started on vaginal progesterone 4 days after the trigger injection for added supplementation per the doctor of record. |
Who may qualify
- Ages
- 18 to 44 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- Participants that are having a single frozen embryo transfer with a euploid embryo.
Key inclusion criteria (3 listed)
- Single euploid frozen embryo transfer
- ≥ 7 mm endometrial lining on transvaginal ultrasound
- 1st or 2nd frozen embryo transfer
Key exclusion criteria (6 listed)
- Obesity with body mass index > 40
- Underweight with body mass index < 18.5
- Utilization of a gestational carrier
- History of recurrent pregnancy loss (≥ 2 spontaneous abortions)
- Uterine factors (history of uterine adhesions, uterine surgery, fibroids, polyps)
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 |
|---|---|---|
| Abdominal ultrasound measurement of the endometrial liningOn the day of the participants frozen embryo transfer, an endometrial thickness measurement (T2) will obtained from an abdominal ultrasound during the embryo transfer. | Diagnostic test | Exogenous hormone replacement thaw cycle, Natural thaw cycle |
Primary outcome
Clinical pregnancy rate
Time frame: through study completion, an average of 1 year
defined as confirmation of gestational sac with fetal heart beat on ultrasound between 6 - 9 weeks gestation
3 secondary outcomes
Biochemical pregnancy rate
Time frame: through study completion, an average of 1 year
Live birth rate
Time frame: through study completion, an average of 1 year
Miscarriage rate
Time frame: through study completion, an average of 1 year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Mar 2022.
- Derived from this study: PubMed 35357436Shah JS, Vaughan DA, Dodge LE, Leung A, Korkidakis A, Sakkas D, Ryley DA, Penzias AS, Toth TL. Endometrial compaction does not predict live birth in single euploid frozen embryo transfers: a prospective study. Hum Reprod. 2022 May 3;37(5):980-987. doi: 10.1093/humrep/deac060.
- 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.
Alan Penzias, MD principal investigator
Boston IVF
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 Boston IVF 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 6 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 11 Mar 2022. 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?
Results are not available in the source record.
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?
Clinical pregnancy rate (time frame: through study completion, an average of 1 year). 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 NCT04330066, 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 11 Mar 2022.