Clinical Trial

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

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Record status
This record was last updated February 4, 2026 (before its estimated April 2026 completion). Its status may not reflect the trial's current state.
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.
Protocol Amendment History 1 amendment
This ClinicalTrials.gov record has been amended once since 2026-01-22.
Trial Details
NCT Number NCT07376460
Lead Sponsor Instituto Valenciano de Infertilidad, IVI Alicante
Collaborators: BTI Biotechnology Institute S.L, Fundación IVI
Conditions Poor Ovarian Response, Ovarian Reactivation
Enrollment 10 participants
Start Date 2026-02
Primary Completion 2026-04 (estimated)
Study Completion 2026-06 (estimated)
Updated on ClinicalTrials.gov 2026-02-04