NCT03067623

Brief Summary

The goal of this interventional study is to evaluate the increasing in endometrial thickening after the intrauterine infusion of 0,5-1 ml of autologous Platelet-Rich Plasma (PRP) and the implantation rate in women with thin endometrium undergoing Embryo-transfer, in order to propose a novel therapeutic approach for women with an endometrium \< 7 mm unresponsive to standard 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
200

participants targeted

Target at P75+ for phase_2

Timeline
Completed

Started Feb 2017

Typical duration for phase_2

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

February 26, 2017

Completed
1 day until next milestone

Study Start

First participant enrolled

February 27, 2017

Completed
2 days until next milestone

First Posted

Study publicly available on registry

March 1, 2017

Completed
2.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2019

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

February 27, 2020

Completed
Last Updated

May 23, 2019

Status Verified

May 1, 2019

Enrollment Period

2.8 years

First QC Date

February 26, 2017

Last Update Submit

May 21, 2019

Conditions

Thin EndometriumEndometrial DisorderEndometrial Thickness Not Growing Under Estrogen Stimulation

Keywords

Thin endometriumEndometrial thickness

Outcome Measures

Primary Outcomes (1)

  • Endometrial thickness

    Endometrial thickness \> 7 mm measured by means of transvaginal ultrasound

    24-48h after the intrauterine PRP infusion

Secondary Outcomes (2)

  • Positive pregnancy test rate

    Approximately 3 weeks after treatment

  • Implantation rate

    Approximately 6 weeks after treatment

Other Outcomes (2)

  • Clinical pregnancy rate

    Approximately 8 weeks after treatment

  • Return to spontaneous period

    Approximately 1 to 3 months after treatment

Study Arms (1)

PRP-infusion

EXPERIMENTAL

PRP will be obtained from a fresh whole blood collected from a peripheral vein; the blood sample will be centrifuged at 1500g (RCF) for 10 minutes and the repeated reversal of the tube will allow obtaining the PRP at the concentration required. Then 0,5-1ml of PRP will be infused into the uterine cavity through a Tomcat catheter. The endometrial thickening will be evaluated by ultrasonography 24-48h after the instillation and, if the endometrial lining reaches 7mm the Embryo-transfer will be arranged.

Drug: PRPDevice: Tomcat catheter

Interventions

PRPDRUG

PRP intrauterine infusion

PRP-infusion
Tomcat catheterDEVICE

PRP intrauterine infusion by means Tomcat catheter

PRP-infusion

Eligibility Criteria

Age18 Years - 46 Years
Sexfemale(Gender-based eligibility)
Gender Eligibility DetailsFemale
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • Endometrial thickness \< 7 mm under estrogen replacement therapy or repeated implantation failure
  • Age between 18 and 46 years

You may not qualify if:

  • Age \< 18 and \> 46 years
  • Pregnancy
  • Bleeding diathesis
  • Previous uterine surgery (miomectomy, cesarean section, etc...)
  • Platelet count \< 105/μL
  • Hemoglobin \< 10 g/dL
  • Presence of a tumor in the wound bed or metastatic disease
  • Current diagnosis of cancer
  • Other concomitant active infections

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Pugliese Ciaccio Hospital

Catanzaro, 88100, Italy

RECRUITING

Related Publications (3)

  • Chang Y, Li J, Chen Y, Wei L, Yang X, Shi Y, Liang X. Autologous platelet-rich plasma promotes endometrial growth and improves pregnancy outcome during in vitro fertilization. Int J Clin Exp Med. 2015 Jan 15;8(1):1286-90. eCollection 2015.

    PMID: 25785127BACKGROUND

  • Nazari L, Salehpour S, Hoseini S, Zadehmodarres S, Ajori L. Effects of autologous platelet-rich plasma on implantation and pregnancy in repeated implantation failure: A pilot study. Int J Reprod Biomed. 2016 Oct;14(10):625-628.

    PMID: 27921085BACKGROUND

  • L. Aghajanova, S. Houshdaran, S. Balayan, J. Irwin, H. Huddleston, L. Giudice. Platelets for endometrial regeneration: a novel approach. Fertil Steril. Volume 106, Issue 3, Supplement, Page e82

    BACKGROUND

Related Links

Study Officials

  • Roberta Venturella, MD

    Magna Graecia University of Catanzaro

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Roberta Venturella, MD

CONTACT

+390961883234venturella@unicz.it

Sara Pedri, MD

CONTACT

+390961883234sara.pedri89@gmail.com

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

February 26, 2017

First Posted

March 1, 2017

Study Start

February 27, 2017

Primary Completion

December 31, 2019

Study Completion

February 27, 2020

Last Updated

May 23, 2019

Record last verified: 2019-05

Data Sharing

IPD Sharing
Will not share

Locations

IT(1)