Intra-uterine AdhesionsNCT03881215
Platelet Rich Plasma Following Hysteroscopic Adhesolysis
A study testing Platelet Rich Plasma and intra-uterine balloon in people with Intra-uterine Adhesions, run by Ain Shams University at 1 site in Egypt.
Trial summary
Platelet Rich Plasma Following Hysteroscopic Adhesolysis: A Randomized Clinical Trial Read more about this study
- Who is it for?
- Ages 18 to 40 years, women only
- Conditions the study is for
- Intra-uterine Adhesions
- What is being tested?
- Platelet Rich Plasma and intra-uterine balloon
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 160 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Jan 2016to 10 Jan 2020
- 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 40 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- Age: 18-40 years
- Grade III intra-uterine adhesions
Who cannot join
- Age < 18 or > 40 years.
- Hb < 11 g/dL, platelets < 150.000/mm3.
- Patient taking anticoagulant.
- Patient taking NSAID in the 10 days before procedure.
- Any significant comorbidity or psychiatric disorder that would compromise patient's consent.
- Active cervical or uterine infection.
- Undiagnosed genital bleeding.
- pregnancy.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Platelet Rich Plasma Following Hysteroscopic Adhesolysis: A Randomized Clinical Trial
Platelet Rich Plasma Following Hysteroscopic Adhesolysis: A Randomized Clinical Trial
- Conditions
- Intra-uterine Adhesions
- Being tested
- Platelet Rich Plasma, intra-uterine balloon
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Platelet Rich PlasmaProcedure or surgery
Platelet Rich Plasma
intra-uterine balloonProcedure or surgery
intra-uterine balloon
| Study group | Role | What they receive |
|---|---|---|
| Platelet Rich Plasma | Experimental | PRP Receives: Procedure: Platelet Rich Plasma; Procedure: intra-uterine balloon |
| intra-uterine balloon | Active comparator | Not described Receives: Procedure: intra-uterine balloon |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of adhesion recurrence
recurrence of severe intra-uterine adhesions
Measured: 3 months
Secondary outcomes (2)
Days of menses
Number of days of menstrual cycle following operation
Measured: 3 months
Amount of menses
Number of sanitary pads changed during each menstrual cycle
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Mar 2019
- Study start1 Jan 2016
- Primary completion10 Dec 2019
- Study completion10 Jan 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Intra-uterine AdhesionsStudies of the same condition, open and under way.
- More trials run by Ain Shams UniversityThe 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 160 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ain Shams University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mohamed S Sweed, MD, Ain Shams University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03881215
- Sponsor's protocol ID
- AS1811
- Status last verified
- Jan 2020
- First submitted
- 16 Mar 2019
- Last updated
- 28 Jan 2020
- Results posted
- No
- 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 28 Jan 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Platelet Rich Plasma Following Hysteroscopic Adhesolysis: A Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT03881215
- Acronym / sponsor ID
- AS1811
- Conditions
- Intra-uterine Adhesions
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 160 participants (actual)
- Lead sponsor
- Ain Shams UniversityUniversity, hospital or other
- Study start
- 1 Jan 2016 (actual)
- Primary completion
- 10 Dec 2019 (actual)
- Study completion
- 10 Jan 2020 (actual)
- First posted
- 19 Mar 2019 (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.
Platelet Rich Plasma Following Hysteroscopic Adhesolysis: A Randomized Clinical Trial
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Platelet Rich Plasma | Experimental | Procedure: Platelet Rich Plasma, Procedure: intra-uterine balloonPRP |
| intra-uterine balloon | Active comparator | Procedure: intra-uterine balloon |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- Age: 18-40 years
- Grade III intra-uterine adhesions
Key exclusion criteria (8 listed)
- Age < 18 or > 40 years.
- Hb < 11 g/dL, platelets < 150.000/mm3.
- Patient taking anticoagulant.
- Patient taking NSAID in the 10 days before procedure.
- Any significant comorbidity or psychiatric disorder that would compromise patient's consent.
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 |
|---|---|---|
| Platelet Rich PlasmaPlatelet Rich Plasma | Procedure or surgery | Platelet Rich Plasma |
| intra-uterine balloonintra-uterine balloon | Procedure or surgery | Platelet Rich Plasma, intra-uterine balloon |
Primary outcome
Incidence of adhesion recurrence
Time frame: 3 months
recurrence of severe intra-uterine adhesions
2 secondary outcomes
Days of menses
Time frame: 3 months
Amount of menses
Time frame: 3 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 28 Jan 2020.
- Individual participant dataSharing planned: No
Related trials for Intra-uterine Adhesions
Recruiting
Prevention of Intra-uterine Adhesions Following Laparoscopic and Laparotomic Myomectomy
Myoma
Not yet recruitingObservational study
Safety and Performance of the Semical Adhesion Barrier Gel for Prevention of Intra-uterine Adhesion
Intrauterine Abnormalities in Infertility, Asherman Syndrome
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?
A study testing Platelet Rich Plasma and intra-uterine balloon in people with Intra-uterine Adhesions, run by Ain Shams University at 1 site in Egypt.
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 8 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 28 Jan 2020. 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 Egypt. 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?
Incidence of adhesion recurrence (time frame: 3 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 28 Jan 2020.