FibroidsNCT01671215
Endometrial and Myometrial Changes, With and Without Fibroids
An observational study of Fibroids, run by Meir Medical Center at 1 site in Israel.
Trial summary
fibroids are common among women in fertile age. the relation between fibroids and infertility is controversial. our goal is to claculate a ratio between uterine cavity - endometrium \& myometrium in normal uterine s and study the interference of the cavity in uterine s with fibroids. Read more about this study
- Who is it for?
- Ages 20 to 45 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Fibroids
- How many people
- 0 participants
- Where
- 1 siteIsrael
- Study dates
- Aug 2012to Aug 2014
- 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 20 to 45 years
- Women only
- Healthy volunteers accepted
- Adult
Study population: women at the age of 20-45
Who may be able to join
- women at IVF unit
Who cannot join
- inabilty to measure propperly the uterine dimensions
Trial locations and contacts
1 site in 1 country.
About this study
fibroids are common among women in fertile age. the relation between fibroids and infertility is controversial. our goal is to claculate a ratio between uterine cavity - endometrium \& myometrium in normal uterine s and study the interference of the cavity in uterine s with fibroids.
Read the detailed description
phase 1-
- retrospective measurments of uterine dimensions of 100 women with normal uterin
- measurment of the above during different sycle days in the same woman. 30 women. phase 2- retrospective measurments of 500 uterine dimensions of women with fibroids phase 3- the same for 400 uterine malformations
- Conditions
- Fibroids
- Keywords
- endometrium, myometrium, fibroids, uterine malformations
- Medical subject headings
- Leiomyoma, Uterine Anomalies
What is being measured
The primary outcome is the main question the study is designed to answer.
ratio between normal & abnormal(by fibroid) uterine cavity
Measured: year
Secondary outcomes (1)
ratio between endometriom & myometrium area, circumference &n volume
Measured: year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Aug 2012 (estimated)
- Study startAug 2012
- Primary completionAug 2014
Why it stopped: no enrollment
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for FibroidsStudies 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
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Meir Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- ronni tepper, md, Principal investigator, Tel Aviv University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01671215
- Sponsor's protocol ID
- MMC120026CTIL
- Status last verified
- Apr 2012
- First submitted
- 20 Aug 2012
- Last updated
- 15 Apr 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Apr 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Endometrial and Myometrial Changes, With and Without Fibroids
- ClinicalTrials.gov ID
- NCT01671215
- Acronym / sponsor ID
- MMC120026CTIL
- Conditions
- Fibroids
- Keywords
- endometrium, myometrium, fibroids, uterine malformations
- Study type
- Observational
- Recruitment status
- WithdrawnReason stopped: no enrollment
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Meir Medical CenterUniversity, hospital or other
- Study start
- Aug 2012
- Primary completion
- Aug 2014 (actual)
- First posted
- 23 Aug 2012 (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.
fibroids are common among women in fertile age. the relation between fibroids and infertility is controversial. our goal is to claculate a ratio between uterine cavity - endometrium \& myometrium in normal uterine s and study the interference of the cavity in uterine s with fibroids.
Detailed description
phase 1-
- retrospective measurments of uterine dimensions of 100 women with normal uterin
- measurment of the above during different sycle days in the same woman. 30 women. phase 2- retrospective measurments of 500 uterine dimensions of women with fibroids phase 3- the same for 400 uterine malformations
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 20 to 45 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- women at the age of 20-45
Key inclusion criteria (1 listed)
- women at IVF unit
Key exclusion criteria (1 listed)
- inabilty to measure propperly the uterine dimensions
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
ratio between normal & abnormal(by fibroid) uterine cavity
Time frame: year
1 secondary outcome
ratio between endometriom & myometrium area, circumference &n volume
Time frame: year
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Apr 2015.
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Life Study: Lifestyle Intervention in Fibroid Elimination
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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.
ronni tepper, md principal investigator
Tel Aviv University
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 Fibroids, 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 1 inclusion and 1 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: withdrawn, as of the sponsor's last update on 15 Apr 2015. 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?
The study was withdrawn before enrolling participants, so there are no results.
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?
ratio between normal & abnormal(by fibroid) uterine cavity (time frame: year). 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 15 Apr 2015.