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Completed

NCT Number: NCT03541746

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

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.

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Key information

Conditions

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

Age range

18 year–43 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Ain Shams University Maternity Hospital

Cairo, 11357, Egypt

About this study

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.

Who can participate

Healthy volunteers accepted: No

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

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.

Treatment and study plan

Platelet rich plasma

Biological

After hysteroscopic adhesiolysis, 30 patients will undergo once injection of 5ml PRP into the wall then lining the uterine cavity by 5ml platelet rich plasma gel. Finally, Foley balloon catheter will be inserted intrauterine then inflated and cutting its stem and to be left for two weeks.

Intrauterine Foley's Catheter

Device

After hysteroscopic adhesiolysis, 30 patients will undergo intrauterine insertion of one inflated Foley balloon catheter with cutting its stem only to be left for two weeks.

Primary outcomes

  1. Prevent recurrence of intrauterine adhesions

    Time frame: Reassessed after one month

    Prevent recurrence of intrauterine adhesions after hysteroscopic adhesiolysis assessed by office hysteroscopy according to American Fertility Society adhesion score:

    • Extent of cavity involved: ( <1/3, 1/3 - 2/3, >2/3 )
    • Type of adhesions: (filmy, filmy to dense, dense)
    • menstrual pattern (normal, hypomenorrhea, amenorrhea)

Secondary outcomes

  1. Return of menses

    Time frame: Reassessed after one month

    Return/normalization of expected menses by history (yes/no)

Sponsors and collaborators

Lead sponsor

Ain Shams Maternity Hospital

Other

Registry information

Official study title

The Value of Using Platelet Rich Plasma After Hysteroscopic Lysis of Severe Intrauterine Adhesions (A Randomized Controlled Trial)

Important dates

Study start
2017
Primary completion
2018
Study completion
2018
First posted
May 31, 2018
Registry last updated
May 31, 2018

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.

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