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

• ClinicalTrials.gov Identifier: NCT03541746
• Recruitment Status: Completed
• First Posted: May 31, 2018
• Last Update Posted: May 31, 2018
• Sponsor: Ain Shams Maternity Hospital
• Information provided by (Responsible Party): Ahmed Mohamed Mahmoud Abd El-Wahab Torky, Ain Shams Maternity Hospital

Study Description

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.

Condition or disease	Intervention/treatment	Phase
Intrauterine Adhesion	Biological: Platelet Rich Plasma; Device: Intrauterine Foley's Catheter	Not Applicable

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 (Clinical Trial)
• Actual Enrollment: 60 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Triple (Participant, Investigator, Outcomes Assessor)
• Primary Purpose: Prevention
• Official Title: The Value of Using Platelet Rich Plasma After Hysteroscopic Lysis of Severe Intrauterine Adhesions (A Randomized Controlled Trial)
• Actual Study Start Date: April 1, 2017
• Actual Primary Completion Date: January 31, 2018
• Actual Study Completion Date: January 31, 2018

Arms and Interventions

Arm	Intervention/treatment
Experimental: Study Group; Platelet Rich Plasma	Biological: Platelet 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.
Active Comparator: Control Group; Intrauterine Foley's Catheter	Device: Intrauterine 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.

Outcome Measures

Primary Outcome Measures :

1. 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 Outcome Measures :

1. Return of menses [ Time Frame: Reassessed after one month ]
   Return/normalization of expected menses by history (yes/no)

Eligibility Criteria

• Ages Eligible for Study: 18 Years to 43 Years (Adult)
• Sexes Eligible for Study: Female
• Gender Based Eligibility: Yes
• Accepts Healthy Volunteers: No

Criteria

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.

Contacts and Locations

Locations

Egypt

Ain Shams University Maternity Hospital

Cairo, Egypt, 11357

Sponsors and Collaborators

Ain Shams Maternity Hospital

Investigators

• Study Chair: Mohamed I Amer, MD; Professor
• Study Director: Mortada E Ahmed, MD; Lecturer
• Study Director: Reda M Kamal, MD; Lecturer

More Information

• Responsible Party: Ahmed Mohamed Mahmoud Abd El-Wahab Torky, Principal Investigator, Ain Shams Maternity Hospital
• ClinicalTrials.gov Identifier: NCT03541746
• Other Study ID Numbers: PRP-HLIUA
• First Posted: May 31, 2018
• Last Update Posted: May 31, 2018
• Last Verified: May 2018

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:

Tissue Adhesions; Cicatrix; Fibrosis; Pathologic Processes