- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04330066
Impact of Endometrial Compaction in Euploid Frozen Embryo Transfers
Impact of Endometrial Compaction in Euploid Frozen Embryo Transfers: a Prospective Observational Pilot Study
Study Overview
Status
Conditions
Intervention / Treatment
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 Type
Enrollment (Actual)
Contacts and Locations
Study Locations
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Massachusetts
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Boston, Massachusetts, United States, 02109
- Boston IVF
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
Inclusion Criteria:
- Single euploid frozen embryo transfer
- ≥ 7 mm endometrial lining on transvaginal ultrasound
- 1st or 2nd frozen embryo transfer
Exclusion Criteria:
- 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
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
---|---|
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.
|
On the day of the participants frozen embryo transfer, an endometrial thickness measurement (T2) will obtained from an abdominal ultrasound during the embryo transfer.
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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.
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On the day of the participants frozen embryo transfer, an endometrial thickness measurement (T2) will obtained from an abdominal ultrasound during the embryo transfer.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Clinical pregnancy rate
Time Frame: through study completion, an average of 1 year
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defined as confirmation of gestational sac with fetal heart beat on ultrasound between 6 - 9 weeks gestation
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through study completion, an average of 1 year
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Biochemical pregnancy rate
Time Frame: through study completion, an average of 1 year
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defined as positive beta-hCG but no gestational sac visualized
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through study completion, an average of 1 year
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Live birth rate
Time Frame: through study completion, an average of 1 year
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defined as delivery > 23 weeks gestation
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through study completion, an average of 1 year
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Miscarriage rate
Time Frame: through study completion, an average of 1 year
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defined as the loss of a pregnancy prior to 12 weeks per total number of pregnancies
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through study completion, an average of 1 year
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Collaborators and Investigators
Sponsor
Publications and helpful links
Study record dates
Study Major Dates
Study Start (ACTUAL)
Primary Completion (ANTICIPATED)
Study Completion (ANTICIPATED)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (ACTUAL)
Study Record Updates
Last Update Posted (ACTUAL)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2020P000191
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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