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Thin EndometriumPhase 2NCT03067623

Autologous Platelet-Rich Plasma (PRP) and Endometrial Thickness

A Phase 2 study testing PRP and Tomcat catheter in people with Thin Endometrium and Endometrial Disorder, run by University Magna Graecia at 1 site in Italy.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial 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… Read more about this study

Who is it for?
Ages 18 to 46 years, women only
What is being tested?
PRP and Tomcat catheter
Could I receive a placebo?
No, everyone receives an active treatment
How many people
200 participants
Where
1 siteItaly
Study dates
27 Feb 2017to 27 Feb 2020
Phase
Phase 2
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 46 years
  • Women only
  • No healthy volunteers
  • Adult

Who may be able to join

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

Who cannot join

  • Age < 18 and > 46 years
  • Pregnancy
  • Bleeding diathesis
  • Previous uterine surgery (miomectomy, cesarean section, etc...)
  • Platelet count < 105/μL
  • Hemoglobin < 10 g/dL
Show all 9Show fewer
  • Presence of a tumor in the wound bed or metastatic disease
  • Current diagnosis of cancer
  • Other concomitant active infections

Trial locations and contacts

1 site in 1 country.

Roberta Venturella, MD contact

+390961883234

venturella@unicz.it

Italy1 site, 1 recruiting
  • Pugliese Ciaccio Hospital

    Catanzaro, 88100

    Roberta Venturella, MD, +390961883234, venturella@unicz.it

    Adalgisa Brescia, MD

    Recruiting

Other trials in Italy

About this study

Official title: Intrauterine Infusion of Autologous Platelet-Rich Plasma (PRP) in Women With Thin Endometrium Undergoing Embryo-transfer.

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.

Being tested
PRP, Tomcat catheter
Keywords
Thin endometrium, Endometrial thickness

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • PRPDrug

    PRP intrauterine infusion

  • Tomcat catheterDevice

    PRP intrauterine infusion by means Tomcat catheter

Study groups in NCT03067623
Study groupRoleWhat they receive
PRP-infusionExperimentalPRP 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.
Receives: Drug: PRP; Device: Tomcat catheter

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Endometrial thickness

    Endometrial thickness > 7 mm measured by means of transvaginal ultrasound

    Measured: 24-48h after the intrauterine PRP infusion

Secondary outcomes (2)
  1. Positive pregnancy test rate

    Positive pregnancy test rate after Embryo-transfer

    Measured: 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

    Measured: Approximately 6 weeks after treatment

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted1 Mar 2017
  2. Study start27 Feb 2017
  3. Primary completion31 Dec 2019 (estimated)
  4. Study completion27 Feb 2020 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
200 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03067623
Sponsor's protocol ID
PRP-Et
Status last verified
May 2019
First submitted
26 Feb 2017
Last updated
23 May 2019
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

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

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing PRP and Tomcat catheter in people with Thin Endometrium and Endometrial Disorder, run by University Magna Graecia at 1 site in Italy.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 2 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 23 May 2019. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Contact Roberta Venturella, MD (+390961883234, venturella@unicz.it), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Endometrial thickness (time frame: 24-48h after the intrauterine PRP infusion). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03067623, which also lists 3 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 May 2019.

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