Autologous Platelet-Rich Plasma in the Management of Asherman Syndrome

NCT04308811 | Completed Phase 2

• 1 other identifier: ASU456
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

The aim of the study is to find out the benefit of the platelet-rich plasma in preventing reformation of intrauterine adhesions after adhesiolysis in cases of Asherman syndrome

Conditions

Intrauterine Adhesion

Outcome Measures

Primary Outcomes (1)

• Grade of intrauterine adhesions

  Grade of intrauterine adhesions

  after one month

Secondary Outcomes (1)

• menstruation

  within three months postoperative

Study Arms (3)

platelet rich plasma group

OTHER

intrauterine platelet rich plasma injection and intrauterine balloon insertion after hysteroscopic lysis of intrauterine adhesions

Biological: platelet rich plasma

amniotic membrane graft group

OTHER

the clinician will perform hysteroscopic lysis of intrauterine adhesions followed by application of intrauterine balloon covered by freeze-dried amniotic membranes.

Combination Product: amniotic membrane graft group

intrauterine balloon group

OTHER

the clinician will perform hysteroscopic lysis of intrauterine adhesions followed by application of intrauterine balloon

Device: Intrauterine balloon

Interventions

platelet rich plasma BIOLOGICAL

Platelet rich plasma and intrauterine balloon applied intrauterine after hysteroscopic adhesiolysis of intrauterine adhesions

platelet rich plasma group

amniotic membrane graft group COMBINATION_PRODUCT

amniotic membrane applied on the intrauterine balloon after hysteroscopic lysis of intrauterine adhesions

amniotic membrane graft group

Intrauterine balloon DEVICE

intrauterine balloon applied intrauterine after hysteroscopic lysis of intrauterine adhesions

intrauterine balloon group

Eligibility Criteria

• Age: 20 Years - 40 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• age group from 20 to 40 years

You may not qualify if:

• Hemoglobin less than 11 g/dl
• Platelet less than 150000/mm3
• Patients taking anticoagulants
• Patients taking NSAID in the 15 days prior to the procedure
• Active cervical or uterine infection

Sponsors & Collaborators

• Ain Shams University: lead

Study Sites (1)

Endoscopy unit, Ain shams university Maternity hospital

Cairo, Egypt

Location

MeSH Terms

Conditions

Gynatresia

Condition Hierarchy (Ancestors)

Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Model Details: The patients who are diagnosed previously with severe AS will choose an envelope which determines the treatment method. There will be 60 envelops assigning for the groups mixed together in one box. This will ensure a randomized allocation of patients to either group of this study. Hysteroscopy adhesiolysis will be done to all participants in the study. in the first group, Adhesiolysis will be followed by intrauterine use of PRP then insertion of Foley balloon catheter. in the second group, adhesiolysis will be followed by insertion of Foley balloon catheter covered by freeze-dried amniotic graft. In the third group, Adhesiolysis will be followed by insertion of Foley balloon catheter. All foley ballon removed 2 weeks postoperative. All patients will be given antibiotics and hormonal treatment. Also, they will be given low dose aspirin and sildenafil 50mg daily.

Study Record Dates

• First Submitted: December 14, 2018
• First Posted: March 16, 2020
• Study Start: August 10, 2019
• Primary Completion: February 20, 2020
• Study Completion: February 20, 2020
• Last Updated: March 16, 2020

Record last verified: 2020-03

Locations

EG (1)