The Value of Using Platelet Rich Plasma After Hysteroscopic Lysis of Severe Intrauterine Adhesions

Not Applicable

Completed

• Conditions: Intrauterine Adhesion
• Interventions: Biological: Platelet Rich Plasma; Device: Intrauterine Foley's Catheter

• Registration Number: NCT03541746
• Lead Sponsor: Ain Shams Maternity Hospital

Brief Summary

The aim of present study is to evaluate the effect of the use of platelet rich plasma in decreasing recurrence of intrauterine adhesions after its lysis.

Detailed Description

Research question:

In women undergoing hysteroscopic adhesiolysis, does postoperative use of platelet rich plasma decrease the recurrence of intrauterine adhesions?

Research hypothesis:

In women undergoing hysteroscopic adhesiolysis for Asherman's syndrome, postoperative use of platelet rich plasma may decrease the recurrence of intrauterine adhesions.

Study Timeline

• Study Start: 2017-04-01
• Primary Completion: 2018-01-31
• Study Completion: 2018-01-31
• Study First Submitted: 2018-02-13
• Status Verified: 2018-05
• Study First Submitted QC: 2018-05-29
• Last Update Submitted: 2018-05-29
• Study First Posted: 2018-05-31
• Last Update Posted: 2018-05-31

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 60

Inclusion Criteria

• Infertility due to Asherman's syndrome with history of hypomenorrhea or amenorrhea and infertility and evaluated by office hysteroscopy to confirm the presence of sever adhesions according to American fertility society.

Exclusion Criteria

• Hb < 11 g/dL, platelets < 150.000/mm3
• Patient taking anticoagulant.
• Patient taking NSAID in the 10 days before procedure.
• Any significant comorbidity or psychiatric disorder that would compromise patient's consent.
• Active cervical or uterine infection.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Study Group	Platelet Rich Plasma	Platelet Rich Plasma
Control Group	Intrauterine Foley's Catheter	Intrauterine Foley's Catheter

Primary Outcome Measures

Name	Time	Method
Prevent recurrence of intrauterine adhesions	Reassessed after one month	Prevent recurrence of intrauterine adhesions after hysteroscopic adhesiolysis assessed by office hysteroscopy according to American Fertility Society adhesion score: 1. Extent of cavity involved: ( \<1/3, 1/3 - 2/3, \>2/3 ); 2. Type of adhesions: (filmy, filmy to dense, dense); 3. menstrual pattern (normal, hypomenorrhea, amenorrhea)

Secondary Outcome Measures

Name	Time	Method
Return of menses	Reassessed after one month	Return/normalization of expected menses by history (yes/no)

Trial Locations

Locations (1)

Ain Shams University Maternity Hospital; 🇪🇬 Cairo, Egypt