NCT07376460

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

Biological and Proteomic Characterisation of Platelet-rich Plasma (PRP) Before and After Mobilisation of Haematopoietic Stem Cells in Peripheral Blood From Women With Low Ovarian Response (Low Responders) and in Vitro Evaluation in Human Ovarian Cell Models

• Status: Not Yet Recruiting
• Phase: —
• Study type: Observational
• Enrollment: 10 (estimated)
• Sponsor: Instituto Valenciano de Infertilidad, IVI Alicante · Academic / Other
• Sex: Female
• Age: 18 Years – 43 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed 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.

Conditions

• Poor Ovarian Response
• Ovarian Reactivation

Interventions

Type	Name	Description
COMBINATION_PRODUCT	Platelet Rich Plasma + BMDSCs mobilization	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.

Timeline

• Start date: 2026-02-01
• Primary completion: 2026-04-01
• Completion: 2026-06-01
• First posted: 2026-01-29
• Last updated: 2026-02-04

Locations

1 site across 1 country: Spain