NCT03629132

Brief Summary

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

Trial Health

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
60

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Aug 2018

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 9, 2018

Completed
5 days until next milestone

First Posted

Study publicly available on registry

August 14, 2018

Completed
1 day until next milestone

Study Start

First participant enrolled

August 15, 2018

Completed
12 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2019

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 30, 2019

Completed
Last Updated

August 14, 2018

Status Verified

August 1, 2018

Enrollment Period

12 months

First QC Date

August 9, 2018

Last Update Submit

August 9, 2018

Conditions

Intrauterine Adhesion

Outcome Measures

Primary Outcomes (1)

  • AFS score

    AFS score

    1 year

Study Arms (2)

PRP

EXPERIMENTAL

Platelet-rich plasma

Procedure: Platelet-rich plasma

Gel

SHAM COMPARATOR

Self-crosslinking sodium hyaluronate gel

Procedure: gel

Interventions

Platelet-rich plasmaPROCEDURE

Platelet-rich plasma intrauterine injection

PRP
gelPROCEDURE

Self-crosslinking sodium hyaluronate gel intrauterine injection

Gel

Eligibility Criteria

Age20 Years - 37 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Gynatresia

Interventions

Gels

Condition Hierarchy (Ancestors)

Genital Diseases, FemaleFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesGenital Diseases

Intervention Hierarchy (Ancestors)

ColloidsComplex MixturesDosage FormsPharmaceutical Preparations

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
professor

Study Record Dates

First Submitted

August 9, 2018

First Posted

August 14, 2018

Study Start

August 15, 2018

Primary Completion

August 1, 2019

Study Completion

December 30, 2019

Last Updated

August 14, 2018

Record last verified: 2018-08

Data Sharing

IPD Sharing
Will not share