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Clinical Trials/NCT03541746
NCT03541746CompletedNot Applicable

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

Ain Shams Maternity Hospital2 sites in 1 country60 target enrollmentStarted: April 1, 2017Last updated:
Conditions
Interventions

Trial Snapshot

Phase
Not Applicable
Status
Completed
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

Experimental

Platelet Rich Plasma

Intervention: Platelet Rich Plasma (Biological)

Control Group

Active Comparator

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

Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

Ahmed Mohamed Mahmoud Abd El-Wahab Torky

Principal Investigator

Ain Shams Maternity Hospital

Study Sites (2)

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