PRP Prevents Recurrence of Intrauterine Adhesions | NCT03629132

Studies
PRP Prevents Recurrence of Intrauterine Adhesions

NCT03629132

Sponsor

Yanhong Deng

Status

Unknown status

Last Update Posted

Aug 14, 2018Actual

Enrollment

60Estimated

Phase

Not Applicable

Conditions

Intrauterine Adhesion

Interventions

Platelet-rich plasma
gel

Countries

Not provided

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Aug 2018

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Not yet recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Aug 15, 2018Estimated

Primary Completion Date

Aug 1, 2019Estimated

Completion Date

Dec 30, 2019Estimated

First Submitted Date

Aug 9, 2018

First Submission Date that Met QC Criteria

Aug 9, 2018

First Posted Date

Aug 14, 2018Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Aug 9, 2018

Last Update Posted Date

Aug 14, 2018Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

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

Detailed Description

Inclusion criteria: patients with intrauterine adhesions (AFS score >9 points); age 21 to 40 years old, with fertility requirements.
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.
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.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

60Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
PRP	Experimental	Platelet-rich plasma	Procedure: Platelet-rich plasma
Gel	Sham Comparator	Self-crosslinking sodium hyaluronate gel	Procedure: gel

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Platelet-rich plasma	Procedure	Platelet-rich plasma intrauterine injection	PRP

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
AFS score	AFS score	1 year

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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

Accepts Healthy Volunteers

Sex

Female

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

20 Years

Maximum Age

37 Years

Standard Ages

Adult

Study Population

Not provided

Sampling Method

Not provided

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D006175	Gynatresia

Ancestor Terms

ID	Term
D005831	Genital Diseases, Female
D052776	Female Urogenital Diseases
D005261	Female Urogenital Diseases and Pregnancy Complications
D000091642	Urogenital Diseases

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D005782	Gels

Ancestor Terms

ID	Term
D003102	Colloids
D045424	Complex Mixtures
D004304	Dosage Forms
D004364	Pharmaceutical Preparations

Browse Leaves

Not provided

Browse Branches

Not provided