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Status unknownNCT03067623Updated May 23, 2019

Autologous Platelet-Rich Plasma (PRP) and Endometrial Thickness

A Phase 2 interventional study of PRP and Tomcat catheter in Thin Endometrium, Endometrial Disorder and Endometrial Thickness Not Growing Under Estrogen Stimulation, sponsored by University Magna Graecia. Status unknown at 1 site in Italy. Open to female participants aged 18 Years to 46 Years. Per ClinicalTrials.gov, last updated 2019-05-23.

Sponsored by University Magna Graecia · Phase 2, Interventional, and Treatment

The sponsor has not verified this record recently (last verified May 2019), so the status shown — last known as Recruiting — may be out of date.
Phase
Phase 2
Study type
Interventional
Enrollment
200
Allocation
Not applicable
Ages
18 Years to 46 Years
Sex
Female
01

Study 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.

Read the detailed description

In clinical practice, a thin endometrium, unresponsive to conventional therapies, usually results in cycle cancellation and embryo cryopreservation. The evaluation of an adequate endometrial growth is performed using grey-scale ultrasound. The minimal endometrial thickness required for embryo transfer is now considered about 7 mm at the end of natural or medically induced follicular phase, despite some investigators reported different cutoff values, ranging between 7 and 10 mm. Currently, no evidence-based data show the predictive positive value of endometrial thickness on pregnancy rate after Embryo-transfer, but if the endometrial lining is below 7mm the chance of pregnancy is statistically significant reduced.

Thin endometrium is relatively frequent in women with previous trauma of the uterus (cesarean sections, repetitive curettage), patients subjected to antitumoral treatments in childhood (Radiotherapy, Chemotherapy, Surgery), women affected by Asherman's syndrome, chronic infections (endometritis, Pelvic Inflammatory Disease) and inadequate blood flow (stress, malposition of uterus, fibrosis), patients with low estradiol values or excessive use of Clomiphene Citrate.

Several alternative treatments have been proposed over the years to improve the endometrial thickening, then showed themselves to be not considered the answer in many cases: some of them, indeed, require a not damaged endometrium, other act on endometrial blood flow and have no direct proliferative effect on the endometrium. The only factor presumed to have a proliferative effect on endometrium is the Granulocyte-Colony Stimulating Factor (G-CSF) but this hypothesis is not supported by in vitro studies.

Recently, first results from an in vitro study ongoing on the evaluation of Platelet-Rich Plasma (PRP) effect on endometrial cell proliferation have been presented (Aghayanova et al., 2016). The authors demonstrated that PRP increased proliferation not only on cultured fibroblasts, as currently known but also on mesenchymal cells, which are progenitors of different types of cells, including endometrial cells. This evidence supports the hypothesis that PRP stimulates some of the cellular processes involved in endometrial regeneration, that can be relevant to the management of a thin lining.

Autologous Platelet-Rich Plasma is prepared from fresh whole blood which is collected from a peripheral vein and processed to separate platelets from the other blood components. PRP contains activating platelets that stimulate the action of cytokines and growth factors. On the basis of this evidence, local intrauterine infusion of PRP may improve endometrial growth and implantation.

Patients considered to be candidates for a PRP application must undergo a minor hematological evaluation to exclude blood disorders or platelet dysfunction. The study, since it involves the use of a blood component, was approved by Ethical Committee and all participant have to sign an informed written consent before undergoing the procedure.

Any concerns of immunogenic reactions or disease transmission, that exist with homologous blood products, are eliminated because PRP is produced from autologous blood. Preparation of PRP, however, demands many processing steps, thus there is the theoretic possibility of contamination. For these reasons, all samples are subjected to quality and sterility controls within a closed mechanism. No wound infections after PRP applications have been reported. Despite PGF has mitogenic properties, there is no evidence that the growth factors included in PRP promote tumor growth or that they are involved in carcinogenesis.

02

Conditions studied

  • Thin Endometrium
  • Endometrial Disorder
  • Endometrial Thickness Not Growing Under Estrogen Stimulation

Keywords

  • Thin endometrium
  • Endometrial thickness
03

In context

Lead sponsor

University Magna Graecia is the lead sponsor of 75 studies on the registry; 5 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 46 Years
Sexes eligible
Female
Accepts healthy volunteers
No

Inclusion criteria

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

Exclusion criteria

Exclusion Criteria:

  • 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
05

Study design

Phase
Phase 2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
200 participants (estimated)

Study arms

  • Experimental
    PRP-infusion

    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: PRP · Device: Tomcat catheter

Interventions

  • DrugPRP

    PRP intrauterine infusion

  • DeviceTomcat catheter

    PRP intrauterine infusion by means Tomcat catheter

06

What researchers measure

Primary outcomes

  1. Endometrial thickness

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

    Time frame: 24-48h after the intrauterine PRP infusion

Secondary outcomes

  1. Positive pregnancy test rate

    Positive pregnancy test rate after Embryo-transfer

    Time frame: Approximately 3 weeks after treatment

  2. Implantation rate

    defined by number of gestational sacs seen on early pregnancy 6-week ultrasound divided by number of embryos transferred

    Time frame: Approximately 6 weeks after treatment

Other outcomes

  1. Clinical pregnancy rate

    Defined by the number of fetal poles with heartbeat seen on 6-week ultrasound divided by the number of embryos transferred

    Time frame: Approximately 8 weeks after treatment

  2. Return to spontaneous period

    Records of a menstrual flow diary (Menstrual Assessment Chart) for 1-3 months after treatment

    Time frame: Approximately 1 to 3 months after treatment

07

Study locations

1 of 1 sites recruiting
  • Pugliese Ciaccio Hospital
    Catanzaro, 88100, Italy
    • Roberta Venturella, MD · Contact · venturella@unicz.it · +390961883234
    • Adalgisa Brescia, MD · Sub investigator
    • Andrea Dominijanni, MD · Sub investigator
    • Sara Pedri, MD · Sub investigator
    Recruiting
08

References and documents

Publications

  • 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. PubMed 25785127 ↗
  • 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. PubMed 27921085 ↗
  • 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

Related links

Individual participant data

Plan to share: No

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on May 23, 2019, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT03067623
Lead sponsor
University Magna Graecia
Responsible party
Roberta Venturella (Principal Investigator, University Magna Graecia) — Principal investigator
First posted
Mar 1, 2017
Start date
Feb 27, 2017
Primary completion
Dec 31, 2019 (estimated)
Completion
Feb 27, 2020 (estimated)
Last update
May 23, 2019

Study contacts

Roberta Venturella, MD
Contact
venturella@unicz.it
+390961883234
Sara Pedri, MD
Contact
sara.pedri89@gmail.com
+390961883234
Roberta Venturella, MD
principal investigator · Magna Graecia University of Catanzaro

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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This study is status unknown, as verified in May 2019. You cannot join it, but the record below documents what was studied.

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