Asherman SyndromeNCT01377779
Efficiency of Intercoat (Oxiplex/AP Gel)in Decreasing Intrauterine Adhesions
A study testing Oxiplex/AP gel and Normal Saline in people with Asherman Syndrome, run by Assaf-Harofeh Medical Center at 1 site in Israel.
Trial summary
This is a prospective single blind randomized controlled pilot study was designed to investigate whether the biological barrier Intercoat (Oxiplex/AP gel) reduces formation of intrauterine adhesions following hysteroscopic treatment for retained products of conception. Read more about this study
- Who is it for?
- Ages 18 to 50 years, women only
- Conditions the study is for
- Asherman Syndrome
- What is being tested?
- Oxiplex/AP gel and Normal Saline
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 60 participants
- Where
- 1 siteIsrael
- Study dates
- Sep 2009to Feb 2011
- 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 50 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- Age between 18 and 50 years
- Availability of the results of vaginal ultrasound or diagnostic hysteroscopy
Who cannot join
- Signs of infection upon admission
- Ongoing pregnancy
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Intercoat (Oxiplex/AP Gel) for Preventing Intrauterine Adhesions Following Operative Hysteroscopy for Suspected Retained Products of Conception - a Prospective Randomized Pilot Study
This is a prospective single blind randomized controlled pilot study was designed to investigate whether the biological barrier Intercoat (Oxiplex/AP gel) reduces formation of intrauterine adhesions following hysteroscopic treatment for retained products of conception.
Read the detailed description
Thirty women randomly divided equally into those who received Intercoat following hysteroscopic treatment for retained products of conception (study group) and those who did not receive the gel (controls). Safety and efficacy of the preparation were evaluated.
- Conditions
- Asherman Syndrome
- Being tested
- Oxiplex/AP gel, Normal Saline
- Keywords
- Oxiplex/AP gel, Prevention of Asherman's syndrome, Intra uterine adhesions
- Medical subject headings
- Gynatresia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Oxiplex/AP gelDrug
Also called Intercoat
Intrauterine application of Intercoat following hysteroscopy
Normal SalineDrug
Also called Distention media
No intrauterine application of Intercoat following hysteroscopy
| Study group | Role | What they receive |
|---|---|---|
| Intercoat treatment | Experimental | women treated by Intercoat gel following hysteroscopy for retained products of conception Receives: Drug: Oxiplex/AP gel |
| Control group | Placebo comparator | No additional treatment following hysteroscopy was performed Receives: Drug: Normal Saline |
What is being measured
The primary outcome is the main question the study is designed to answer.
safety of intrauterine application of Intercoat
women treated by Intercoat following their hysteroscopic procedure were followed for immediate and late adverse effects; fever, increased intrauterine adhesion formation upon follow up and changes in menstrual pattern
Measured: 18 months
Secondary outcomes (1)
efficacy of intrauterine application of Intercoat gel in reducing adhesion formation following hysteroscopic treatment for retained products of conception
intrauterine adhesions were graded according to the AFS score upon hysteroscopic follow up 6-8 weeks following initial treatment
Measured: 14 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Jun 2011 (estimated)
- Study startSep 2009
- Primary completionNov 2010
- Study completionFeb 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Asherman SyndromeStudies 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
- Randomised
- Intervention model
- Single group
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Assaf-Harofeh Medical Center
- Sponsor type
- Other government
- Investigators
- Moty Pansky, MD, Principal investigator, Asaf Harofe MC
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01377779
- Sponsor's protocol ID
- 2*13/09
- Status last verified
- Jul 2009
- First submitted
- 15 Jun 2011
- Last updated
- 21 Jun 2011
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 21 Jun 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Intercoat (Oxiplex/AP Gel) for Preventing Intrauterine Adhesions Following Operative Hysteroscopy for Suspected Retained Products of Conception - a Prospective Randomized Pilot Study
- ClinicalTrials.gov ID
- NCT01377779
- Acronym / sponsor ID
- 2*13/09
- Conditions
- Asherman Syndrome
- Keywords
- Oxiplex/AP gel, Prevention of Asherman's syndrome, Intra uterine adhesions
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Assaf-Harofeh Medical CenterOther government
- Study start
- Sep 2009
- Primary completion
- Nov 2010 (actual)
- Study completion
- Feb 2011 (actual)
- First posted
- 21 Jun 2011 (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 is a prospective single blind randomized controlled pilot study was designed to investigate whether the biological barrier Intercoat (Oxiplex/AP gel) reduces formation of intrauterine adhesions following hysteroscopic treatment for retained products of conception.
Detailed description
Thirty women randomly divided equally into those who received Intercoat following hysteroscopic treatment for retained products of conception (study group) and those who did not receive the gel (controls). Safety and efficacy of the preparation were evaluated.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intercoat treatment | Experimental | Drug: Oxiplex/AP gelwomen treated by Intercoat gel following hysteroscopy for retained products of conception |
| Control group | Placebo comparator | Drug: Normal SalineNo additional treatment following hysteroscopy was performed |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- Age between 18 and 50 years
- Availability of the results of vaginal ultrasound or diagnostic hysteroscopy
Key exclusion criteria (2 listed)
- Signs of infection upon admission
- Ongoing pregnancy
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 |
|---|---|---|
| Oxiplex/AP gelAlso: IntercoatIntrauterine application of Intercoat following hysteroscopy | Drug | Intercoat treatment |
| Normal SalineAlso: Distention mediaNo intrauterine application of Intercoat following hysteroscopy | Drug | Control group |
Primary outcome
safety of intrauterine application of Intercoat
Time frame: 18 months
women treated by Intercoat following their hysteroscopic procedure were followed for immediate and late adverse effects; fever, increased intrauterine adhesion formation upon follow up and changes in menstrual pattern
1 secondary outcome
efficacy of intrauterine application of Intercoat gel in reducing adhesion formation following hysteroscopic treatment for retained products of conception
Time frame: 14 months
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 21 Jun 2011.
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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.
Moty Pansky, MD principal investigator
Asaf Harofe MC
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Oxiplex/AP gel and Normal Saline in people with Asherman Syndrome, run by Assaf-Harofeh 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 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: finished, as of the sponsor's last update on 21 Jun 2011. 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. Some participants in this study may receive a placebo. 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?
safety of intrauterine application of Intercoat (time frame: 18 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 21 Jun 2011.