Proteomic and Biological Characterisation of Plasma for the Study of Changes Following Ovarian Reactivation Treatment

Trial statusNot yet recruiting
Trial phaseNot listed
Trial typeObservational
Biological sexFemale
Age18-43
SponsorInstituto Valenciano de Infertilidad, IVI Alicante

About this trial

The samples used in PRGF treatments owe their effectiveness to the handling, concentration, and preservation of their components, which explains why samples obtained with different platelet-rich plasma preparation systems may vary. At IVIRMA Group, we employ the closed system PRGF-Endoret to process these samples for StemCell Regenera samples obtained after mobilizing stem cells with granulocyte colony-stimulating factor stimulators. According to current regulations, PRP samples are considered medicinal products by AEMPS, requiring knowledge of the composition of processed samples to be administered to the patient. The study and quantification of samples used in StemCell Regenera treatments aim to understand how stem cell mobilization performed through this technique influences the characteristics of PRGF-Endoret. In this context, the present project aims to systematically analyse the proteomic profile of PRP/PRGF before and after haematopoietic stem cell mobilisation in poor-responder patients, and to evaluate its biological impact in vitro using human ovarian cell models. This approach will enable the identification of key factors involved in ovarian activation and regeneration, thereby providing a mechanistic basis for optimising regenerative therapies applied in clinical reproductive medicine. Furthermore, it will contribute scientifically relevant insights to the field of research and to patients themselves.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Patients aged between 18 and 43.

Patients diagnosed with poor ovarian response (POR) or low ovarian reserve according to Bolonia criteria (ESHRE).

Patients who are indicated for a StemCell Regenera procedure with the use of granulocyte colony-stimulating factors (Filgrastim).

Patients who agree to participate and sign the informed consent form.

Disqualifiers

Patients over the age of 43.

Patients with only one ovary.

Patients with an autoimmune or haematological disorder.

Patients currently undergoing treatment with anticoagulant drugs.

Trial population

Patients from IVI Alicante who decide to undergo the ovarian reactivation treatment "StemCell Regenera" at the clinic for improving ovarian function

Trial design

Design model

Other

Time perspective

Prospective

Treatments tested in this trial

  • Platelet Rich Plasma + BMDSCs mobilization

    Combination product

    This intervention entails, in addition to routine platelet-rich plasma (PRP) isolation, prior mobilization of bone marrow derived stem cells into the peripheral blood using filgrastim, a granulocyte colony-stimulating factor. Consequently, the patient benefits both from the stem cells and their paracrine effects on the ovaries, as well as from the direct effects of intraovarian PRP instillation. Overall, this approach provides multiple benefits derived from two distinct biological sources.

Treatment groups

10 Participants
are divided into 1 treatment group
Group A: Poor responders undergoing ovarian reactivation StemCell Regenera1 intervention

Trial outcomes

Primary outcomes

1

Biological and proteomic characterisation of the platelet rich plasma

Proteomic and biological characterisation of the platelet rich plasma before and after the peripheral blood mobilization of bone marrow derived stem cells in women with poor ovarian response who undergo the ovarian reactivation treatment StemCell Regenera

Time frame
From enrollment to the end of treatment (4 day treatment) at day 5
2

In vitro functional studies with human ovarian cells

In vitro evaluation of the functional effect of PRP both before and after the stem cell mobilization on peripheral blood over human derived ovarian cells, analysing viability and proliferation parameters

Time frame
From enrollment to the end of treatment (4 day treatment) at day 5

Secondary outcomes

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Instituto Valenciano de Infertilidad, IVI Alicante

Lead sponsor

BTI Biotechnology Institute S.L

Collaborator

Fundación IVI

Collaborator

This trial is not recruiting at the moment. You can still explore other options: