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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04308811
Other study ID # ASU456
Secondary ID
Status Completed
Phase Phase 2
First received
Last updated
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
Health authority
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

Study Design


Related Conditions & MeSH terms


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
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