NCT02973555

Brief Summary

Platelet-rich plasma (PRP) may promote the endometrial growth and improve pregnancy outcome of patients with thin endometrium undergoing ART treatments.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
50

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jan 2017

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

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

November 22, 2016

Completed
3 days until next milestone

First Posted

Study publicly available on registry

November 25, 2016

Completed
1 month until next milestone

Study Start

First participant enrolled

January 1, 2017

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2018

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2019

Completed
Last Updated

November 25, 2016

Status Verified

November 1, 2016

Enrollment Period

1 year

First QC Date

November 22, 2016

Last Update Submit

November 22, 2016

Conditions

Infertility

Outcome Measures

Primary Outcomes (1)

  • endometrial thickness >7mm

    1 month

Secondary Outcomes (1)

  • Positive serum pregnancy test

    14 days post embryo transfer

Study Arms (1)

PRP injection

EXPERIMENTAL
Other: PRP injection

Interventions

PRP injectionOTHER

autologous intrauterine infusion of PRP

PRP injection

Eligibility Criteria

Age18 Years - 54 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • Women undergoing a frozen thawed embryo transfer cycle with poor endometrial response to estrogen (\< 7 mm) after at least two standard preparation protocols, of which one was canceled due to thin endometrium

You may not qualify if:

  • none

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hadassah Medical Organization

Jerusalem, Israel

Location

MeSH Terms

Conditions

Infertility

Condition Hierarchy (Ancestors)

Genital DiseasesUrogenital Diseases

Study Officials

  • Ronit Kochman, MD

    Hadassah Medical Organization

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Ronit Kochman, MD

CONTACT

+972 508946414kochman@hadassah.org.il

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 22, 2016

First Posted

November 25, 2016

Study Start

January 1, 2017

Primary Completion

January 1, 2018

Study Completion

January 1, 2019

Last Updated

November 25, 2016

Record last verified: 2016-11

Data Sharing

IPD Sharing
Will not share

Locations

IL(1)