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

Instituto Valenciano de Infertilidad, IVI Alicante

Status: Not yet enrolling

Conditions: Ovarian Reactivation; Poor Ovarian Response

Treatments: Combination Product: Platelet Rich Plasma + BMDSCs mobilization

Study type: Observational

Funder types: Other

Identifiers

NCT07376460

2510-ALC-124-MM

Details and patient eligibility

About

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.

Full description

The study design is based on a comparative analysis of the biological and proteomic profiles of platelet-rich plasma enriched with platelet-derived growth factors (PRP/PRGF) processed using the PRGF Endoret® kit, comparing samples obtained before (PRE) and after (POST) stem cell mobilization. The aim is to define the changes induced by the paracrine effect of bone marrow-derived stem cells (CD34⁺) mobilized into peripheral blood.

Enrollment: 10 estimated patients

Sex: Female

Ages: 18 to 43 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• 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.

Exclusion criteria

• 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.
• Patients who are allergic to Filgrastim, the granulocyte colony-stimulating factor.

Trial design

10 participants in 1 patient group

Poor responders undergoing ovarian reactivation StemCell Regenera

Description:

Women who present a profile of poor responders meaning they have a poor response towards the ovarian stimulation treatment, yielding a low number of oocytes after oocyte retrieval and moreover want to undergo the ovarian reactivation treatment StemCell Regenera.

Treatment:

Combination Product: Platelet Rich Plasma + BMDSCs mobilization