PRP Prevents Recurrence of Intrauterine Adhesions (RPR-IUAs)

August 9, 2018 updated by: Yanhong Deng

Platelet-rich Plasma(PRP) Prevents Recurrence of Intrauterine Adhesions

Effect of platelet-rich plasma (PRP) on uterine scar fibrosis, endometrial receptivity and pregnancy outcome in patients with severe intrauterine adhesions

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Detailed Description

  1. Inclusion criteria: patients with intrauterine adhesions (AFS score >9 points); age 21 to 40 years old, with fertility requirements.
  2. Study design:prospective, randomized controlled cohort study, patients with intrauterine adhesions were randomized into two groups, the control group and the intervention group (intraoperative and postoperative 1 week postoperative PRP). The surgical procedures and postoperative medication regimens were the same.
  3. Compare the biochemical pregnancy rate, clinical pregnancy rate, abortion rate and live birth rate after hysteroscopic resection in PRP group and control group, and explore the effect of PRP on pregnancy outcome after intrauterine adhesion.

Study Type

Interventional

Enrollment (Anticipated)

60

Phase

  • Not Applicable

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 35 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

Inclusion Criteria:Patients with intrauterine adhesions (AFS score >9 points); age 21 to 40 years old, with fertility requirements -

Exclusion Criteria:Endometrial tuberculosis, endometrial polyps, uterine submucosal fibroids, endometrial hyperplasia, endometrial malignant lesions, premature ovarian failure, chromosomal abnormalities

-

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: PRP
Platelet-rich plasma
Procedure: Platelet-rich plasma
Platelet-rich plasma intrauterine injection
Sham Comparator: Gel
Self-crosslinking sodium hyaluronate gel
Procedure: gel
Self-crosslinking sodium hyaluronate gel intrauterine injection

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
AFS score
Time Frame: 1 year
AFS score
1 year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Yanhong Deng

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Anticipated)

August 15, 2018

Primary Completion (Anticipated)

August 1, 2019

Study Completion (Anticipated)

December 30, 2019

Study Registration Dates

First Submitted

August 9, 2018

First Submitted That Met QC Criteria

August 9, 2018

First Posted (Actual)

August 14, 2018

Study Record Updates

Last Update Posted (Actual)

August 14, 2018

Last Update Submitted That Met QC Criteria

August 9, 2018

Last Verified

August 1, 2018

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • RPR-IUAs

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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