Clinical trial NCT04308811: Autologous Platelet-Rich Plasma in the Management of Asherman Syndrome
Official title: Platelet-Rich Plasma in the Management of Asherman Syndrome
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Intrauterine Adhesion
Lead sponsor: Ain Shams University
Sponsor class: OTHER
First posted: 2020-03-16
Enrollment: 60
Sex: FEMALE
Minimum age (years): 20
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: 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.
Primary purpose: TREATMENT

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

Detailed 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.

Eligibility criteria: 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

Primary outcomes:
measure: Grade of intrauterine adhesions
timeFrame: after one month
Secondary outcomes:
measure: menstruation
timeFrame: within three months postoperative
Other outcomes:
Locations:
city: Cairo
country: Egypt
facility: Endoscopy unit, Ain shams university Maternity hospital
Study officials:
References: