Global Medicare · Publications & Evidence

The evidence behind the scientific questions.

Explore clinical studies, randomized trials, observational research and biological background relevant to Global Medicare’s ovarian and endometrial research programs.

Clinical trials Peer-reviewed research Scientific background

Published findings are heterogeneous and should be interpreted according to study design, population and clinical context.

Reading the evidence

Not every publication answers the same question.

Study design matters. A randomized clinical trial, a prospective cohort, a pilot study and a biological review provide different types and levels of information.

RCT Randomized trial

Designed for controlled comparison between groups.

COHORT Prospective cohort

Observes outcomes prospectively in a defined population.

PILOT Pilot study

Provides preliminary clinical information in smaller samples.

REVIEW Review

Synthesizes previously published scientific literature.

ABSTRACT Congress abstract

Preliminary scientific communication rather than a full article.

Ovarian Clinical Evidence

Intraovarian PRP: promising signals, heterogeneous results.

Published studies have evaluated intraovarian PRP in women with poor ovarian response, diminished ovarian reserve and primary ovarian insufficiency.

Results differ between studies, and improvements in intermediate parameters do not necessarily translate into improved blastocyst quality, pregnancy or live birth.

RCT

Intraovarian platelet-rich plasma injection and IVF outcomes in patients with poor ovarian response

Barrenetxea G. et al. · Human Reproduction · 2024 · 39(4):760–769

Double-blind randomized controlled trial. The study reported an increase in retrieved oocytes, without improvement in the quality of resulting blastocysts.

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Clinical study

First data on IVF and blastocyst formation after intraovarian injection of autologous platelet-rich plasma

Sills E.S. et al. · Gynecological Endocrinology · 2018

Early clinical data describing ovarian and IVF-related parameters following intraovarian autologous PRP.

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Clinical cohort

Effects of intraovarian autologous platelet-rich plasma on ovarian reserve and IVF outcomes in primary ovarian insufficiency

Cakiroglu Y. et al. · Aging · 2020 · 12:10211–10222

Clinical study reporting ovarian-reserve and IVF-related outcomes after intraovarian PRP in women with primary ovarian insufficiency.

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Pilot

Reactivating ovarian function through autologous platelet-rich plasma intraovarian infusion

Sfakianoudis K. et al. · Journal of Clinical Medicine · 2020

Pilot data involving premature ovarian insufficiency, perimenopausal, menopausal and poor-responder populations.

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Prospective cohort

Preliminary report of intraovarian PRP in patients with extremely poor functional ovarian reserve

Barad D.H. et al. · Human Reproduction Open · 2022

Prospective cohort that did not demonstrate clinically relevant improvement in ovarian function during the observation period.

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Endometrial Clinical Evidence

PRP has been studied directly in thin endometrium and implantation-related settings.

Published research includes randomized trials, pilot studies and clinical cohorts examining endometrial expansion and reproductive outcomes after intrauterine PRP.

Double-blind RCT

Effects of autologous platelet-rich plasma on endometrial expansion in frozen-thawed embryo transfer

Nazari L. et al. · International Journal of Reproductive BioMedicine · 2019

Double-blind randomized controlled trial evaluating intrauterine PRP in patients with inadequate endometrial growth.

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RCT

Can autologous PRP expand endometrial thickness and improve pregnancy rate during frozen embryo transfer?

Eftekhar M. et al. · Taiwan Journal of Obstetrics & Gynecology · 2018

Randomized clinical trial evaluating endometrial thickness and pregnancy outcomes in frozen-thawed embryo-transfer cycles.

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Clinical study

Autologous PRP infusion improves clinical pregnancy rate in FET cycles for women with thin endometrium

Chang Y. et al. · Medicine · 2019

Clinical study examining intrauterine PRP in women with thin endometrium undergoing frozen embryo transfer.

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Pilot

Autologous PRP treatment on refractory thin endometrium during frozen embryo-transfer cycles

Kim H. et al. · Frontiers in Endocrinology · 2019

Pilot study evaluating PRP treatment in refractory thin endometrium.

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Self-controlled

Intrauterine PRP and embryo implantation in women with repeated implantation failure

Kusumi M. et al. · Reproductive Medicine and Biology · 2020

Single-arm self-controlled study examining endometrial thickness and implantation in recurrent implantation failure.

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Biological Background

Platelets are more than components of haemostasis.

Activated platelets release growth factors, cytokines and other naturally occurring biological components involved in tissue signalling and repair.

This biological background helps explain why autologous platelet-rich preparations have been investigated across several medical disciplines.

GF · 01 Growth factors

Platelet-derived signalling includes PDGF, TGF-β, VEGF, EGF and other biological factors.

ANG · 02 Angiogenesis

Platelet-derived factors participate in vascular and tissue-repair signalling.

ECM · 03 Tissue remodelling

Published biological research describes roles in extracellular-matrix and cellular responses.

EV · 04 Extracellular vesicles

Platelets also release extracellular vesicles that participate in intercellular communication.

Mechanistic Evidence

Extracellular-vesicle biology is scientific background — not proof of IAS efficacy.

Extracellular vesicles are naturally occurring membrane-bound particles involved in intercellular communication and the transport of biologically active molecules.

Research on platelet-derived extracellular vesicles provides mechanistic background relevant to regenerative biology.

This evidence must not be used to describe IAS as purified exosome therapy or to claim proven clinical superiority.

Review

Advances in platelet-rich plasma-derived extracellular vesicles for regenerative medicine

Anitua E. et al. · International Journal of Molecular Sciences · 2023

Systematic-narrative review of platelet-rich plasma-derived extracellular vesicles and regenerative-medicine research.

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Review

Shedding light on the cell biology of extracellular vesicles

van Niel G., D’Angelo G., Raposo G. · Nature Reviews Molecular Cell Biology · 2018

Fundamental review of extracellular-vesicle biology, biogenesis and intercellular communication.

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Clinical Background

The research programs sit within broader reproductive-medicine evidence.

The protocols also draw on established literature concerning poor ovarian response, PCOS, chronic endometritis, adenomyosis, implantation failure and recurrent pregnancy loss.

OVARIAN POSEIDON classification

A structured framework for describing low-prognosis patients undergoing ovarian stimulation.

ENDOMETRIAL Chronic endometritis

Systematic-review literature addresses the relationship between chronic endometritis and altered embryo implantation.

UTERINE Adenomyosis

Systematic review and meta-analysis have evaluated fertility, pregnancy and neonatal outcomes associated with adenomyosis.

Our Research

Building prospective evidence from current clinical pathways.

The current REGEN-AR studies are designed to document ovarian and endometrial outcomes prospectively in patients receiving Standard-PRP or IAS within routine clinical care.

Ongoing observational research

ExoRegenOvo

Study 02-REGEN-AR · ovarian research at IVF Baden-Baden. Results are not yet presented as published study outcomes.

Study 02-REGEN-AR
Ongoing observational research

RegenEndo

Study 03-REGEN-AR · endometrial research at IVF Baden-Baden. Results are not yet presented as published study outcomes.

Study 03-REGEN-AR
Congress contribution · 2023

O-221

Regenerative endometrial PRGF treatment in patients with thin endometrium, recurrent implantation failure and recurrent miscarriages: a retrospective, self-controlled cohort study.

Human Reproduction

Scientific Interpretation

Evidence should clarify uncertainty, not hide it.

Current literature provides a scientific rationale for continued research, but important questions remain regarding patient selection, magnitude of effect and comparative clinical outcomes.

01 PRP evidence ≠ IAS evidence

Published PRP studies cannot automatically be interpreted as clinical validation of IAS.

02 Mechanism ≠ clinical benefit

Biological evidence regarding growth factors or extracellular vesicles does not prove improved reproductive outcomes.

03 Observational ≠ randomized

ExoRegenOvo and RegenEndo are prospective observational, non-randomized studies and must be interpreted accordingly.

Continue exploring

Evidence provides context. Research asks the next question.

Explore the scientific background, the ongoing REGEN-AR studies or the patient programs connected with ovarian and endometrial specialist evaluation.

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