Skip to content

The Value of Using Platelet Rich Plasma After Hysteroscopic Lysis of Severe Intrauterine Adhesions

The Value of Using Platelet Rich Plasma After Hysteroscopic Lysis of Severe Intrauterine Adhesions (A Randomized Controlled Trial)

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03541746
Enrollment
60
Registered
2018-05-31
Start date
2017-04-01
Completion date
2018-01-31
Last updated
2018-05-31

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Intrauterine Adhesion

Brief 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.

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.

Interventions

BIOLOGICALPlatelet Rich Plasma

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.

DEVICEIntrauterine Foley's Catheter

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.

Sponsors

Ain Shams Maternity Hospital
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender
FEMALE
Age
18 Years to 43 Years
Healthy volunteers
No

Inclusion criteria

* 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.

Exclusion criteria

* 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.

Design outcomes

Primary

MeasureTime frameDescription
Prevent recurrence of intrauterine adhesionsReassessed after one monthPrevent 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)

Secondary

MeasureTime frameDescription
Return of mensesReassessed after one monthReturn/normalization of expected menses by history (yes/no)

Countries

Egypt

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026