Infertility, FemaleNCT03147144
Ultrasonographic Measurements of Uterine Junctional Zone and Association With In Vitro Fertilization Treatment Outcome
An observational study of Infertility, Female, run by Hillel Yaffe Medical Center at 1 site in Israel.
Trial summary
The aim of this study is to prospectively examine the relationship of the uterine junctional zone thickness, evaluated by ultrasonography and In Vitro Fertilization (IVF) treatment outcome. Read more about this study
- Who is it for?
- Ages 18 to 40 years, women only
- Conditions the study is for
- Infertility, Female
- What is being tested?
- Ultrasonographic imaging
- How many people
- 80 participants
- Where
- 1 siteIsrael
- Study dates
- May 2017to May 2018
- 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 40 years
- Women only
- Adult
Study population: Women attending the IVF clinic at Hillel Yaffe Medical Center
Who may be able to join
- Undergoing IVF treatment due to male factor, polycystic ovary syndrome and unexplained infertility
Who cannot join
- Low ovarian reserve
- Having undergone more than one D\&C
Trial locations and contacts
1 site in 1 country.
Israel1 site
Hillel Yaffe Medical Center
Hadera, 38100
Livna Shafat Heller, MD, 972-50-3321230, livnashafat@gmail.com
About this study
The aim of this study is to prospectively examine the relationship of the uterine junctional zone thickness, evaluated by ultrasonography and In Vitro Fertilization (IVF) treatment outcome. The study hypothesis is that the uterine junctional zones of women who did not achieve pregnancy will be thicker than those of the women who do achieve pregnancy
Read the detailed description
Ultrasounds of women who achieve pregnancy after IVF treatment will be compared to ultrasounds of women who do not achieve pregnancy. Their uterine junctional zone thickness will be compared.
The study hypothesis is that the uterine junctional zones of women who did not achieve pregnancy will be thicker than those of the women who do achieve pregnancy.
- Conditions
- Infertility, Female
- Being tested
- Ultrasonographic imaging
- Medical subject headings
- Infertility, Female
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ultrasonographic imagingOther
Ultrasound pelvic scan
What is being measured
The primary outcome is the main question the study is designed to answer.
Thickened uterine junctional zone
Observed and measured by ultrasound
Measured: 2 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 May 2017
- Study startMay 2017 (estimated)
- Primary completionMay 2018 (estimated)
- Study completionMay 2018 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hillel Yaffe Medical Center
- Sponsor type
- Other government
- Responsible party
- Sponsor
- Investigators
- Livna Shafat Heller, MD, Principal investigator, Hillel Yaffe Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03147144
- Sponsor's protocol ID
- HYMC-0031-17
- Status last verified
- May 2017
- First submitted
- 8 May 2017
- Last updated
- 10 May 2017
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 May 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Ultrasonographic Measurements of Uterine Junctional Zone and Association With In Vitro Fertilization Treatment Outcome
- ClinicalTrials.gov ID
- NCT03147144
- Acronym / sponsor ID
- HYMC-0031-17
- Conditions
- Infertility, Female
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- Hillel Yaffe Medical CenterOther government
- Study start
- May 2017 (estimated)
- Primary completion
- May 2018 (estimated)
- Study completion
- May 2018 (estimated)
- First posted
- 10 May 2017 (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 aim of this study is to prospectively examine the relationship of the uterine junctional zone thickness, evaluated by ultrasonography and In Vitro Fertilization (IVF) treatment outcome. The study hypothesis is that the uterine junctional zones of women who did not achieve pregnancy will be thicker than those of the women who do achieve pregnancy
Detailed description
Ultrasounds of women who achieve pregnancy after IVF treatment will be compared to ultrasounds of women who do not achieve pregnancy. Their uterine junctional zone thickness will be compared.
The study hypothesis is that the uterine junctional zones of women who did not achieve pregnancy will be thicker than those of the women who do achieve pregnancy.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 40 years
- Sex
- Female only
- Age groups
- Adult
- Study population
- Women attending the IVF clinic at Hillel Yaffe Medical Center
Key inclusion criteria (1 listed)
- Undergoing IVF treatment due to male factor, polycystic ovary syndrome and unexplained infertility
Key exclusion criteria (2 listed)
- Low ovarian reserve
- Having undergone more than one D\&C
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 |
|---|---|---|
| Ultrasonographic imagingUltrasound pelvic scan | Other | – |
Primary outcome
Thickened uterine junctional zone
Time frame: 2 months
Observed and measured by ultrasound
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 May 2017.
- 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.
Livna Shafat Heller, MD principal investigator
Hillel Yaffe Medical Center
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 Hillel Yaffe 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 1 inclusion and 2 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 10 May 2017. 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 Livna Shafat Heller, MD (972-50-3321230, livnashafat@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Thickened uterine junctional zone (time frame: 2 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 10 May 2017.