The Value of Using Platelet Rich Plasma After Hysteroscopic Lysis of Severe Intrauterine Adhesions (A Randomized Controlled Trial)
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Ain Shams Maternity Hospital
- Enrollment
- 60
- Locations
- 2
- Primary Endpoint
- Prevent recurrence of intrauterine adhesions
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Prevention
- Masking
- Triple (Participant, Investigator, Outcomes Assessor)
Eligibility Criteria
- Ages
- 18 Years to 43 Years (Adult)
- Sex
- Female
- Accepts 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.
Arms & Interventions
Study Group
Platelet Rich Plasma
Intervention: Platelet Rich Plasma (Biological)
Control Group
Intrauterine Foley's Catheter
Intervention: Intrauterine Foley's Catheter (Device)
Outcomes
Primary Outcomes
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)
Secondary Outcomes
- Return of menses(Reassessed after one month)
Investigators
Ahmed Mohamed Mahmoud Abd El-Wahab Torky
Principal Investigator
Ain Shams Maternity Hospital