Intrauterine AdhesionsNCT02404454
Prevention of Intrauterine Adhesions After Hysteroscopic Metroplasty With Autocross-linked Hyaluronic Acid Gel
A study testing Hysteroscopic metroplasty, Autocross-linked acid hyaluronic gel and Office second look hysteroscopy in people with Intrauterine Adhesions and Septate Uterus, run by University of Cagliari.
Trial summary
The septate uterus is the most common structural uterine anomaly. It results from failure of the partition between the two fused Müllerian ducts to resorb;it is associated with the highest incidence of reproductive failure and with first- and second-trimester pregnancy loss and infertility. Read more about this study
- Who is it for?
- Ages 18 to 45 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Intrauterine Adhesions, Septate Uterus
- What is being tested?
- Hysteroscopic metroplasty, Autocross-linked acid hyaluronic gel and Office second look hysteroscopy
- Type of treatment
- Medical device, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- No sites listed yet
- Study dates
- Jun 2016to Mar 2017
- 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 45 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- uterine septum
- history of ≥1 miscarriage or infertility;
- desire to have children in the future
Who cannot join
- pregnancy;
- menopause;
- precancerous state or malignancy of the reproductive organs;
- benign lesions in the myometrium of the uterine fundus (myomas or adenomyosis)
- lesions distorting the uterine cavity (submucosal myomas or intrauterine adhesions) on ultrasonography;
- withdrawal of patient consent;
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- rare complex uterine congenital anomalies without an ASRM classification such as uterine septum with double cervix ;
- presence of external intercornual cleft;
- incomplete (internal fundal indentation 10 mm) or non-standardized septum resection (internal fundal indentation ,10 mm and uterine myometrial thickness .10 mm at the fundus), confirmed intraoperatively
- excessive fundal incision (uterine myometrial thickness ,6 mm at the fundus confirmed intraoperatively)
About this study
The septate uterus is the most common structural uterine anomaly. It results from failure of the partition between the two fused Müllerian ducts to resorb;it is associated with the highest incidence of reproductive failure and with first- and second-trimester pregnancy loss and infertility.
Hysteroscopic division of the uterine septum is performed using microscissors, electrosurgery, or laser. Several studies shown significant improvement in pregnancy outcome after hysteroscopic metroplasty.
Purpose of this study is to verify the effectiveness of 5 ml, instead of 10 ml, of autocross-linked hyaluronic acid gel in the prevention of the formation of intrauterine adhesions, through second look office hysteroscopy after three months.
- Conditions
- Intrauterine Adhesions, Septate Uterus
- Being tested
- Hysteroscopic metroplasty, Autocross-linked acid hyaluronic gel, Office second look hysteroscopy
- Medical subject headings
- Gynatresia, Septate Uterus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Hysteroscopic metroplastyProcedure or surgery
Autocross-linked acid hyaluronic gelDevice
Patients received adhesion barrier with 5 ml of autocross-linked acid hyaluronic gel
Office second look hysteroscopyProcedure or surgery
Second-look hysteroscopy after three months
| Study group | Role | What they receive |
|---|---|---|
| hysteroscopic metroplasty | Experimental | women undergoing hysteroscopic metroplasty for uterine septum resection Receives: Procedure: Hysteroscopic metroplasty; Device: Autocross-linked acid hyaluronic gel; Procedure: Office second look hysteroscopy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Formation of intrauterine adhesions
Measured: baseline (operative isteroscopy and three months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Mar 2015 (estimated)
- Study startJun 2016
- Primary completionDec 2016 (estimated)
- Study completionMar 2017 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Intrauterine AdhesionsStudies 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
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Cagliari
- Sponsor type
- University, hospital or other
- Collaborators
- Università degli Studi di Sassari, Azienda Sanitaria Locale di Cagliari, Azienda Sanitaria Locale di Olbia, Azienda Sanitaria Locale di Oristano
- Responsible party
- Principal investigator, Stefano Angioni, University of Cagliari
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02404454
- Sponsor's protocol ID
- MulticentricMetroplasty
- Status last verified
- Mar 2016
- First submitted
- 26 Mar 2015
- Last updated
- 9 Mar 2016
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Mar 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prevention of Intrauterine Adhesions After Hysteroscopic Metroplasty With Autocross-linked Hyaluronic Acid Gel
- ClinicalTrials.gov ID
- NCT02404454
- Acronym / sponsor ID
- MulticentricMetroplasty
- Conditions
- Intrauterine Adhesions, Septate Uterus
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- University of CagliariUniversity, hospital or other
- Collaborators
- Università degli Studi di Sassari, Azienda Sanitaria Locale di Cagliari, Azienda Sanitaria Locale di Olbia, Azienda Sanitaria Locale di Oristano
- Study start
- Jun 2016
- Primary completion
- Dec 2016 (estimated)
- Study completion
- Mar 2017 (estimated)
- First posted
- 31 Mar 2015 (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.
The septate uterus is the most common structural uterine anomaly. It results from failure of the partition between the two fused Müllerian ducts to resorb;it is associated with the highest incidence of reproductive failure and with first- and second-trimester pregnancy loss and infertility.
Hysteroscopic division of the uterine septum is performed using microscissors, electrosurgery, or laser. Several studies shown significant improvement in pregnancy outcome after hysteroscopic metroplasty.
Purpose of this study is to verify the effectiveness of 5 ml, instead of 10 ml, of autocross-linked hyaluronic acid gel in the prevention of the formation of intrauterine adhesions, through second look office hysteroscopy after three months.
Study design
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| hysteroscopic metroplasty | Experimental | Procedure: Hysteroscopic metroplasty, Device: Autocross-linked acid hyaluronic gel, Procedure: Office second look hysteroscopywomen undergoing hysteroscopic metroplasty for uterine septum resection |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- uterine septum
- history of ≥1 miscarriage or infertility;
- desire to have children in the future
Key exclusion criteria (10 listed)
- pregnancy;
- menopause;
- precancerous state or malignancy of the reproductive organs;
- benign lesions in the myometrium of the uterine fundus (myomas or adenomyosis)
- lesions distorting the uterine cavity (submucosal myomas or intrauterine adhesions) on ultrasonography;
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 |
|---|---|---|
| Hysteroscopic metroplasty | Procedure or surgery | hysteroscopic metroplasty |
| Autocross-linked acid hyaluronic gelPatients received adhesion barrier with 5 ml of autocross-linked acid hyaluronic gel | Device | hysteroscopic metroplasty |
| Office second look hysteroscopySecond-look hysteroscopy after three months | Procedure or surgery | hysteroscopic metroplasty |
Primary outcome
Change in Formation of intrauterine adhesions
Time frame: baseline (operative isteroscopy and three months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Mar 2016.
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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.
Questions about this trial
What is this clinical trial studying?
A study testing Hysteroscopic metroplasty, Autocross-linked acid hyaluronic gel and Office second look hysteroscopy in people with Intrauterine Adhesions and Septate Uterus, run by University of Cagliari.
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 3 inclusion and 10 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 9 Mar 2016. Status can change between updates, so confirm with the study contact before making plans.
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?
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?
Change in Formation of intrauterine adhesions (time frame: baseline (operative isteroscopy and three 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 9 Mar 2016.