InfertilityNCT02817373
Implantation Prediction by Three Dimensional (3D) Ultrasound in Fresh Embryo Transfers
A study testing Ultrasound scan performed through a vaginal probe in people with Infertility, run by Meir Medical Center at 1 site in Israel.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 40 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Infertility
- What is being tested?
- Ultrasound scan performed through a vaginal probe
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 150 participants
- Where
- 1 siteIsrael
- Study dates
- Nov 2016to 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 40 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Single day 5 fresh embryo transfer of good quality
- Age<40
Who cannot join
- Frozen embryo transfer
- Age>40
- Day 2-3 transfer
- Double embryo transfer
Trial locations and contacts
1 site in 1 country.
Israel1 site, 1 recruiting
- Recruiting
Meir Medical Center
Kfar Saba, Israel
Anat Hershko Klement, MD, 972549170084, anat.klement@gmail.com
About this study
Official title: 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.
Read the 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.
- Conditions
- Infertility
- Being tested
- Ultrasound scan performed through a vaginal probe
- Keywords
- IVF, embryo transfer, ultrasound, implantation
- Medical subject headings
- Infertility
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ultrasound scan performed through a vaginal probeOther
5-8 minute scan recording : endometrial thickness, endometrial pattern, endometrial -myometrial junction appearance, subendometrial wave contractions (presence and number), endometrial surface area
| Study group | Role | What they receive |
|---|---|---|
| transvaginal ultrasound study | Other | 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. Receives: Other: Ultrasound scan performed through a vaginal probe |
What is being measured
The primary outcome is the main question the study is designed to answer.
implantation of a fresh high quality embryo
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.
Measured: outcome measure will be known within 4 weeks of the embryo transfer
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jun 2016 (estimated)
- Study startNov 2016
- Primary completionAug 2018 (estimated)
- Study completionDec 2018 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for InfertilityStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 150 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Meir Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Amir Wiser, MD, Principal investigator, Meir Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02817373
- Sponsor's protocol ID
- 123-16MMC
- Status last verified
- Dec 2016
- First submitted
- 20 Jun 2016
- Last updated
- 30 Dec 2016
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- No
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.
PubMed 8970487Matsuura 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.
PubMed 20079898Hershko-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.
PubMed 27140291
Study at a glance
From the registry record, last updated by the sponsor on 30 Dec 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Implantation Prediction Model by the Use of Three Dimensional (3D) Ultrasound in Fresh Embryo Transfers Cycles
- ClinicalTrials.gov ID
- NCT02817373
- Acronym / sponsor ID
- 123-16MMC
- Conditions
- Infertility
- Keywords
- IVF, embryo transfer, ultrasound, implantation
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 150 participants (estimated)
- Lead sponsor
- Meir Medical CenterUniversity, hospital or other
- Study start
- Nov 2016
- Primary completion
- Aug 2018 (estimated)
- Study completion
- Dec 2018 (estimated)
- First posted
- 29 Jun 2016 (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.
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.
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 design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| transvaginal ultrasound study | Other | Other: Ultrasound scan performed through a vaginal probePatients 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. |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- Single day 5 fresh embryo transfer of good quality
- Age<40
Key exclusion criteria (4 listed)
- Frozen embryo transfer
- Age>40
- Day 2-3 transfer
- Double embryo transfer
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 |
|---|---|---|
| Ultrasound scan performed through a vaginal probe5-8 minute scan recording : endometrial thickness, endometrial pattern, endometrial -myometrial junction appearance, subendometrial wave contractions (presence and number), endometrial surface area | Other | transvaginal ultrasound study |
Primary outcome
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.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Dec 2016.
- Background: PubMed 8970487Peduzzi 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.
- Results publication: PubMed 20079898Matsuura 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.
- Results publication: PubMed 27140291Hershko-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.
- Individual participant dataSharing planned: No
Related trials for Infertility
RecruitingObservational study
International Pilot Study for Dual Non-invasive Assesment of Embryo Development
Infertility
Active, not recruitingObservational study
Retrieval of Sperm From Men With Azoospermia Using Ultrasound-guided Rete Testis Aspiration
Azoospermia, Nonobstructive, Infertility, Male
Not yet recruiting
Spinery Basivertebral Nerve Ablation for Vertebrogenic Chronic Low Back Pain
Low Back Pain, Chronic Low Back Pain (CLBP)
RecruitingObservational study
Impact of Infertility on the Sexual Sphere in Couples Undergoing Assisted Reproduction
Sexual Health Quality of Life, Infertile Patients
RecruitingObservational study
Pilot Study of Discarded Blastocysts
Infertility (IVF Patients)
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.
Amir Wiser, MD principal investigator
Meir Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Ultrasound scan performed through a vaginal probe in people with Infertility, run by Meir Medical Center at 1 site in Israel.
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 2 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: status not confirmed, as of the sponsor's last update on 30 Dec 2016. 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 Israel. 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?
Contact Anat Hershko Klement, MD (972549170084, anat.klement@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
implantation of a fresh high quality embryo (time frame: outcome measure will be known within 4 weeks of the 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 NCT02817373, which also lists 3 linked publications.
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 30 Dec 2016.