Autologous Platelet-Rich Plasma in the Management of Asherman Syndrome

Intrauterine Adhesion Clinical Trial

Official title:

Platelet-Rich Plasma in the Management of Asherman Syndrome

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04308811
• Other study ID #: ASU456
• Status: Completed
• Phase: Phase 2
• Start date: August 10, 2019
• Est. completion date: February 20, 2020

Study information

• Verified date: March 2020
• Source: Ain Shams University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

Description:

Patients fulfilling criteria will be randomized into three equal groups. 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 intrauterine Foley balloon catheter that will be inflated and left for 2 weeks. in the second group, adhesiolysis will be followed by insertion of intrauterine Foley balloon catheter covered by freeze-dried amniotic graft and will be inflated and left for 2 weeks. In the third group, Adhesiolysis will be followed by insertion of intrauterine Foley balloon catheter that will be inflated and left for 2 weeks. All patients will be given antibiotics and hormonal treatment. Also, they will be given low dose aspirin and sildenafil 50mg daily.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: February 20, 2020
• Est. primary completion date: February 20, 2020
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 20 Years to 40 Years

Eligibility

Inclusion Criteria: Severe intrauterine synechia confirmed by hysteroscopy

• age group from 20 to 40 years

Exclusion Criteria:

• 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

Related Conditions & MeSH terms

• Intrauterine Adhesion

Intervention

Biological:
• platelet rich plasma
Platelet rich plasma and intrauterine balloon applied intrauterine after hysteroscopic adhesiolysis of intrauterine adhesions

Combination Product:
• amniotic membrane graft group
amniotic membrane applied on the intrauterine balloon after hysteroscopic lysis of intrauterine adhesions

Device:
• Intrauterine balloon
intrauterine balloon applied intrauterine after hysteroscopic lysis of intrauterine adhesions

Locations

Country	Name	City	State
Egypt	Endoscopy unit, Ain shams university Maternity hospital	Cairo

Sponsors (1)

Lead Sponsor	Collaborator
Ain Shams University

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Grade of intrauterine adhesions	Grade of intrauterine adhesions	after one month
Secondary	menstruation	amount of menstrual blood change	within three months postoperative