Skip to main content
OpenTrials
Completed

NCT Number: NCT04308811

Autologous Platelet-Rich Plasma in the Management of Asherman Syndrome

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

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Intrauterine Adhesion Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Genital Diseases Genital Diseases, Female Gynatresia Urogenital Diseases

Age range

20 year–40 year

Sex eligibility

Female

Study type

Interventional

Phase

Phase 2

Primary location

Endoscopy unit, Ain shams university Maternity hospital

Cairo, Egypt

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Platelet rich plasma

Biological

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

amniotic membrane graft group

Combination Product

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

intrauterine balloon

Device

intrauterine balloon applied intrauterine after hysteroscopic lysis of intrauterine adhesions

Primary outcomes

  1. Grade of intrauterine adhesions

    Time frame: after one month

    Grade of intrauterine adhesions

Secondary outcomes

  1. menstruation

    Time frame: within three months postoperative

    amount of menstrual blood change

Sponsors and collaborators

Lead sponsor

Ain Shams University

Other

Registry information

Official study title

Platelet-Rich Plasma in the Management of Asherman Syndrome

Important dates

Study start
2019
Primary completion
2020
Study completion
2020
First posted
Mar 16, 2020
Registry last updated
Mar 16, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.