- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02817373
Implantation Prediction by Three Dimensional (3D) Ultrasound in Fresh Embryo Transfers
December 29, 2016 updated by: Meir Medical Center
Implantation Prediction Model by the Use of Three Dimensional (3D) Ultrasound in Fresh Embryo Transfers Cycles
This study is designed to predict implantation of a fresh, high quality embryo in an in vitro fertilization (IVF) cycle by using ultrasound based uterine factors.
Study Overview
Status
Unknown
Conditions
Intervention / Treatment
Detailed Description
Investigators will recruit patients <40 years with no background morbidities who are being treated with IVF or IVF intra cytoplasmic sperm injection (ICSI) for acceptable indications.
Only patients reaching a blastocyst transfer will be recruited ; this criterion will assist in minimizing embryonal quality as a factor in the implantation chance.
The investigators will limit the quality to good quality embryos, which in the unit's routine practice are transferred in a single embryo transfer.
On Day 5, embryos will be scored for blastocyst formation.
Blastocysts will be graded according to the size of the blastocyst, the assessment of the inner cell mass (ICM) and trophectoderm development as suggested by Gardner.
Good quality embryos (Grade 1-2) will be defined as those where at least: "3" score if the cavity completely fills the embryo, "B" when the ICM is loosely grouped with several cells and "B" when the trophectoderm has very few cells forming a loose epithelium.
Lower criteria embryos on Day 5 will be defined as poor quality embryos (Grade 3 or 4).
Blastocyst grading will be performed by two trained embryologists, each with over 10 years of experience.
The study will not involve any change in the conventional IVF treatment; the only change will involve a 3D trans-vaginal ultrasound at the morning of the embryo transfer, before patients are initiating bladder filling (a common request from all abdominally assisted embryo transfers, facilitating an easier pathway to the uterus and an excellent view).
The estimated time for the ultrasound test is 5-8 minutes and will include recording of the following variables : endometrial thickness, endometrial pattern, endometrial -myometrial junction appearance, subendometrial wave contractions (presence and number), endometrial surface area.
The information will be recoded under the patients' unique study identity number and will be stored in a special computerized archived file secured by Meir medical center data protection and computer unit.
The data will not affect any treatment decisions in the IVF unit unless this examination will reveal for the first time the presence of an unknown uterine polyp or the presence of a hydrosalpinx.
Such scenario is improbable since in the performing unit, patients are routinely going through a uterine cavity assessment and a pelvic ultrasound scan prior to an IVF cycle.
If this indeed happens then the ultrasound unit will contact the IVF unit and the treating physician will discuss the data with the patient in order to decide whether to go on with the transfer or to freeze the embryo/s until treating the new findings.
Upon completion of 150 patients/studies, the ultrasound file will be analyzed by two highly trained and experienced examiners.
Each of the variables collected will be used in a multivariate model for implantation incorporating the patient's age.
Study Type
Interventional
Enrollment (Anticipated)
150
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Amir Wiser, MD
- Phone Number: 97297472901
- Email: amir.wiser@gmail.com
Study Locations
-
-
-
Kfar Saba, Israel
- Recruiting
- Meir Medical Center
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 40 years (Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
Female
Description
Inclusion Criteria:
- Single day 5 fresh embryo transfer of good quality
- Age<40
Exclusion Criteria:
- Frozen embryo transfer
- Age>40
- Day 2-3 transfer
- Double embryo transfer
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Diagnostic
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Other: transvaginal ultrasound study
Patients with a well established infertility requiring IVF treatment and who are <40.
Cohort will consist of patients going through a fresh day 5 transfer with a planned transfer of a single good quality embryo.
Patients will go thorough a Ultrasound scan performed through a vaginal probe on the morning of the embryo transfer.
|
5-8 minute scan recording : endometrial thickness, endometrial pattern, endometrial -myometrial junction appearance, subendometrial wave contractions (presence and number), endometrial surface area
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
implantation of a fresh high quality embryo
Time Frame: outcome measure will be known within 4 weeks of the embryo transfer
|
Implantation is defined as the presence of a gestational sac as will be assessed by a vaginal ultrasound probe 4 weeks after the embryo transfer.
Implantation is expected to exist only in cases of a positive pregnancy test; in such cases the ultrasound can either describe an absence of sac, a single sac or multiple sacs.
|
outcome measure will be known within 4 weeks of the embryo transfer
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Amir Wiser, MD, Meir Medical Center
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
- Peduzzi P, Concato J, Kemper E, Holford TR, Feinstein AR. A simulation study of the number of events per variable in logistic regression analysis. J Clin Epidemiol. 1996 Dec;49(12):1373-9. doi: 10.1016/s0895-4356(96)00236-3.
- Matsuura K, Hayashi N, Takiue C, Hirata R, Habara T, Naruse K. Blastocyst quality scoring based on morphologic grading correlates with cell number. Fertil Steril. 2010 Aug;94(3):1135-7. doi: 10.1016/j.fertnstert.2009.11.003. Epub 2010 Jan 15.
- Hershko-Klement A, Tepper R. Ultrasound in assisted reproduction: a call to fill the endometrial gap. Fertil Steril. 2016 Jun;105(6):1394-1402.e4. doi: 10.1016/j.fertnstert.2016.04.012. Epub 2016 Apr 29.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
November 1, 2016
Primary Completion (Anticipated)
August 1, 2018
Study Completion (Anticipated)
December 1, 2018
Study Registration Dates
First Submitted
June 20, 2016
First Submitted That Met QC Criteria
June 26, 2016
First Posted (Estimate)
June 29, 2016
Study Record Updates
Last Update Posted (Estimate)
December 30, 2016
Last Update Submitted That Met QC Criteria
December 29, 2016
Last Verified
December 1, 2016
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 123-16MMC
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
No
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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