Intrauterine AdhesionNCT03541746
The Value of Using Platelet Rich Plasma After Hysteroscopic Lysis of Severe Intrauterine Adhesions
A study testing Platelet Rich Plasma and Intrauterine Foley's Catheter in people with Intrauterine Adhesion, run by Ain Shams Maternity Hospital at 1 site in Egypt.
Trial summary
The aim of present study is to evaluate the effect of the use of platelet rich plasma in decreasing recurrence of intrauterine adhesions after its lysis. Read more about this study
- Who is it for?
- Ages 18 to 43 years, women only
- Conditions the study is for
- Intrauterine Adhesion
- What is being tested?
- Platelet Rich Plasma and Intrauterine Foley's Catheter
- Type of treatment
- Injection or infusion, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Apr 2017to 31 Jan 2018
- 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 43 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- Infertility due to Asherman's syndrome with history of hypomenorrhea or amenorrhea and infertility and evaluated by office hysteroscopy to confirm the presence of sever adhesions according to American fertility society.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Value of Using Platelet Rich Plasma After Hysteroscopic Lysis of Severe Intrauterine Adhesions (A Randomized Controlled Trial)
The aim of present study is to evaluate the effect of the use of platelet rich plasma in decreasing recurrence of intrauterine adhesions after its lysis.
Read the detailed description
Research question:
In women undergoing hysteroscopic adhesiolysis, does postoperative use of platelet rich plasma decrease the recurrence of intrauterine adhesions?
Research hypothesis:
In women undergoing hysteroscopic adhesiolysis for Asherman's syndrome, postoperative use of platelet rich plasma may decrease the recurrence of intrauterine adhesions.
- Conditions
- Intrauterine Adhesion
- Being tested
- Platelet Rich Plasma, Intrauterine Foley's Catheter
- Medical subject headings
- Gynatresia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Platelet Rich PlasmaBiological
After hysteroscopic adhesiolysis, 30 patients will undergo once injection of 5ml PRP into the wall then lining the uterine cavity by 5ml platelet rich plasma gel. Finally, Foley balloon catheter will be inserted intrauterine then inflated and cutting its stem and to be left for two weeks.
Intrauterine Foley's CatheterDevice
After hysteroscopic adhesiolysis, 30 patients will undergo intrauterine insertion of one inflated Foley balloon catheter with cutting its stem only to be left for two weeks.
| Study group | Role | What they receive |
|---|---|---|
| Study Group | Experimental | Platelet Rich Plasma Receives: Biological: Platelet Rich Plasma |
| Control Group | Active comparator | Intrauterine Foley's Catheter Receives: Device: Intrauterine Foley's Catheter |
What is being measured
The primary outcome is the main question the study is designed to answer.
Prevent recurrence of intrauterine adhesions
Prevent recurrence of intrauterine adhesions after hysteroscopic adhesiolysis assessed by office hysteroscopy according to American Fertility Society adhesion score:
- Extent of cavity involved: ( <1/3, 1/3 - 2/3, >2/3 )
- Type of adhesions: (filmy, filmy to dense, dense)
- menstrual pattern (normal, hypomenorrhea, amenorrhea)
Measured: Reassessed after one month
Secondary outcomes (1)
Return of menses
Return/normalization of expected menses by history (yes/no)
Measured: Reassessed after one month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 May 2018
- Study start1 Apr 2017
- Primary completion31 Jan 2018
- Study completion31 Jan 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Intrauterine AdhesionStudies 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
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ain Shams Maternity Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ahmed Mohamed Mahmoud Abd El-Wahab Torky, Ain Shams Maternity Hospital
- Investigators
- Mohamed I Amer, MD, Study chair, ProfessorMortada E Ahmed, MD, Study director, LecturerReda M Kamal, MD, Study director, Lecturer
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03541746
- Sponsor's protocol ID
- PRP-HLIUA
- Status last verified
- May 2018
- First submitted
- 13 Feb 2018
- Last updated
- 31 May 2018
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 31 May 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Value of Using Platelet Rich Plasma After Hysteroscopic Lysis of Severe Intrauterine Adhesions (A Randomized Controlled Trial)
- ClinicalTrials.gov ID
- NCT03541746
- Acronym / sponsor ID
- PRP-HLIUA
- Conditions
- Intrauterine Adhesion
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Ain Shams Maternity HospitalUniversity, hospital or other
- Study start
- 1 Apr 2017 (actual)
- Primary completion
- 31 Jan 2018 (actual)
- Study completion
- 31 Jan 2018 (actual)
- First posted
- 31 May 2018 (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.
The aim of present study is to evaluate the effect of the use of platelet rich plasma in decreasing recurrence of intrauterine adhesions after its lysis.
Detailed description
Research question:
In women undergoing hysteroscopic adhesiolysis, does postoperative use of platelet rich plasma decrease the recurrence of intrauterine adhesions?
Research hypothesis:
In women undergoing hysteroscopic adhesiolysis for Asherman's syndrome, postoperative use of platelet rich plasma may decrease the recurrence of intrauterine adhesions.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Study Group | Experimental | Biological: Platelet Rich PlasmaPlatelet Rich Plasma |
| Control Group | Active comparator | Device: Intrauterine Foley's CatheterIntrauterine Foley's Catheter |
Who may qualify
- Ages
- 18 to 43 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- Infertility due to Asherman's syndrome with history of hypomenorrhea or amenorrhea and infertility and evaluated by office hysteroscopy to confirm the presence of sever adhesions according to American fertility society.
Key exclusion criteria (5 listed)
- 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.
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 PlasmaAfter hysteroscopic adhesiolysis, 30 patients will undergo once injection of 5ml PRP into the wall then lining the uterine cavity by 5ml platelet rich plasma gel. Finally, Foley balloon catheter will be inserted intrauterine then inflated and cutting its stem and to be left for two weeks. | Biological | Study Group |
| Intrauterine Foley's CatheterAfter hysteroscopic adhesiolysis, 30 patients will undergo intrauterine insertion of one inflated Foley balloon catheter with cutting its stem only to be left for two weeks. | Device | Control Group |
Primary outcome
Prevent recurrence of intrauterine adhesions
Time frame: Reassessed after one month
Prevent recurrence of intrauterine adhesions after hysteroscopic adhesiolysis assessed by office hysteroscopy according to American Fertility Society adhesion score: 1. Extent of cavity involved: ( <1/3, 1/3 - 2/3, >2/3 ) 2. Type of adhesions: (filmy, filmy to dense, dense) 3. menstrual pattern (normal, hypomenorrhea, amenorrhea)
1 secondary outcome
Return of menses
Time frame: Reassessed after one month
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 31 May 2018.
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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.
Mohamed I Amer, MD study chair
Professor
Mortada E Ahmed, MD study director
Lecturer
Reda M Kamal, MD study director
Lecturer
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 Intrauterine Foley's Catheter in people with Intrauterine Adhesion, run by Ain Shams Maternity Hospital 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 1 inclusion and 5 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 31 May 2018. 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?
Prevent recurrence of intrauterine adhesions (time frame: Reassessed after one month). 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 31 May 2018.