Uterine SeptumUTER-SEPTUMNCT05139446
Reproductive Outcomes Following Uterine Septum Resection
An observational study of Uterine Septum, run by University Hospital, Strasbourg, France at 1 site in France.
Trial summary
Nowadays, there is little data to validate the performance of surgical hysteroscopies in the case of septate uterus, particularly in the case of incidental discoveries. Clinical practice and the experience of teams leads to propose this procedure, but strong evidence for this recommendation is lacking and there is an… Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Uterine Septum
- How many people
- 400 participants
- Where
- 1 siteFrance
- Study dates
- 1 Jan 2020to 2 Jul 2021
- 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 years and older
- Women only
- Adult, Older adult
Study population: Major female (≥18 years old) being an operating patient at the strabourg university hospital or Bicetre Hospital between January 2009 and December 2019.
Who may be able to join
- Major female (≥18 years old) To be an operating patient at the strabourg university hospital or Bicetre Hospital between January 2009 and December 2019.
Who cannot join
- Particular clinical forms of the disease, (associated enlargement metroplasties, other uterine maformations) Minor patients, patients under guardianship
Trial locations and contacts
1 site in 1 country.
France1 site
Service de Gynécologie Obstétrique - Hôpitaux Universitaires de Strasbourg
Strasbourg, 67091
About this study
Official title: Reproductive Outcomes Following Uterine Septum Resection- a Bicentric Retrospective Study
Nowadays, there is little data to validate the performance of surgical hysteroscopies in the case of septate uterus, particularly in the case of incidental discoveries. Clinical practice and the experience of teams leads to propose this procedure, but strong evidence for this recommendation is lacking and there is an urgent need for solid data.
A recent randomized trial contradicts this recommendation, but the methodology is questionable on several points.
Read more
Investigators wished to associate 2 reference centers with current practice and expertise on this procedure in order to have a cohort of many patients and to have more powerful results.) Investigators purpose a retrospective observational data-based study. The aim is to describe the profile of patients with a partitioned uterus in terms of obstetrical history and to study the consequences of uterine partition resection in terms of obstetrical prognosis (live births, at term, number of miscarriages or premature births).
The aim of this study is to take into account the evaluation of the surgical hysteroscopy gesture by postoperative imaging with in particular the indication of a resection in several stages in case of residual postoperative septum.
- Conditions
- Uterine Septum
- Keywords
- uterine septum, Hysteroscopic septum resection, Metroplasty, Subfertility, Infertility, Preterm delivery, Spontaneous abortion
- Medical subject headings
- Septate Uterus, Infertility, Premature Birth, Abortion, Spontaneous
What is being measured
The primary outcome is the main question the study is designed to answer.
Retrospective study of the uterine septum resection technique by operative hysteroscopy
Measured: Files analysed retrospectively from January 01, 2009 to December 31, 2019 will be examined]
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Dec 2021
- Study start1 Jan 2020
- Primary completion2 May 2021
- Study completion2 Jul 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Uterine SeptumStudies of the same condition, open and under way.
- More trials run by University Hospital, Strasbourg, FranceThe sponsor's other registered studies.
- 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
- Case only
- Time perspective
- Retrospective
- Enrolment
- 400 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Strasbourg, France
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05139446
- Sponsor's protocol ID
- 8070
- Acronym
- UTER-SEPTUM
- Status last verified
- Oct 2021
- First submitted
- 13 Oct 2021
- Last updated
- 3 Nov 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Nov 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Reproductive Outcomes Following Uterine Septum Resection- a Bicentric Retrospective Study
- ClinicalTrials.gov ID
- NCT05139446
- Acronym / sponsor ID
- UTER-SEPTUM / 8070
- Conditions
- Uterine Septum
- Keywords
- uterine septum, Hysteroscopic septum resection, Metroplasty, Subfertility, Infertility, Preterm delivery, Spontaneous abortion
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 400 participants (actual)
- Lead sponsor
- University Hospital, Strasbourg, FranceUniversity, hospital or other
- Study start
- 1 Jan 2020 (actual)
- Primary completion
- 2 May 2021 (actual)
- Study completion
- 2 Jul 2021 (actual)
- First posted
- 1 Dec 2021 (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.
Nowadays, there is little data to validate the performance of surgical hysteroscopies in the case of septate uterus, particularly in the case of incidental discoveries. Clinical practice and the experience of teams leads to propose this procedure, but strong evidence for this recommendation is lacking and there is an urgent need for solid data.
A recent randomized trial contradicts this recommendation, but the methodology is questionable on several points.
Investigators wished to associate 2 reference centers with current practice and expertise on this procedure in order to have a cohort of many patients and to have more powerful results.) Investigators purpose a retrospective observational data-based study. The aim is to describe the profile of patients with a partitioned uterus in terms of obstetrical history and to study the consequences of uterine partition resection in terms of obstetrical prognosis (live births, at term, number of miscarriages or premature births).
The aim of this study is to take into account the evaluation of the surgical hysteroscopy gesture by postoperative imaging with in particular the indication of a resection in several stages in case of residual postoperative septum.
Study design
- Observational model
- Case only
- Time perspective
- Retrospective
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Age groups
- Adult, Older adult
- Study population
- Major female (≥18 years old) being an operating patient at the strabourg university hospital or Bicetre Hospital between January 2009 and December 2019.
Key inclusion criteria (1 listed)
- Major female (≥18 years old) To be an operating patient at the strabourg university hospital or Bicetre Hospital between January 2009 and December 2019.
Key exclusion criteria (1 listed)
- Particular clinical forms of the disease, (associated enlargement metroplasties, other uterine maformations) Minor patients, patients under guardianship
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
Retrospective study of the uterine septum resection technique by operative hysteroscopy
Time frame: Files analysed retrospectively from January 01, 2009 to December 31, 2019 will be examined]
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Nov 2023.
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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.
The record lists no contact. Use the official record to reach the sponsor.
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 Uterine Septum, run by University Hospital, Strasbourg, France at 1 site in France.
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: finished, as of the sponsor's last update on 3 Nov 2023. 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 France. 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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Retrospective study of the uterine septum resection technique by operative hysteroscopy (time frame: Files analysed retrospectively from January 01, 2009 to December 31, 2019 will be examined]). 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 3 Nov 2023.