Ignite Creation Date:
2026-03-26 @ 3:19 PM
Ignite Modification Date:
2026-03-31 @ 1:21 PM
Study NCT ID:
NCT07376460
Status:
NOT_YET_RECRUITING
Last Update Posted:
2026-02-04
First Post:
2026-01-22
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Proteomic and Biological Characterisation of Plasma for the Study of Changes Following Ovarian Reactivation Treatment
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2026-03-25'}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'OTHER'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 10}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2026-02', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2026-01', 'completionDateStruct': {'date': '2026-06', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2026-02-02', 'studyFirstSubmitDate': '2026-01-22', 'studyFirstSubmitQcDate': '2026-01-22', 'lastUpdatePostDateStruct': {'date': '2026-02-04', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2026-01-29', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-04', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Biological and proteomic characterisation of the platelet rich plasma', 'timeFrame': 'From enrollment to the end of treatment (4 day treatment) at day 5', 'description': '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'}, {'measure': 'In vitro functional studies with human ovarian cells', 'timeFrame': 'From enrollment to the end of treatment (4 day treatment) at day 5', 'description': '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'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Poor ovarian response', 'ovarian reactivation', 'StemCell Regenera', 'ovarian rejuvenation therapy', 'ovarian failure', 'Stem cell mobilization', 'PRP', 'PRGF', 'Bone Marrow Derived Stem Cells (BMDSC)'], 'conditions': ['Poor Ovarian Response', 'Ovarian Reactivation']}, 'referencesModule': {'references': [{'pmid': '32532000', 'type': 'BACKGROUND', 'citation': 'Sfakianoudis K, Simopoulou M, Grigoriadis S, Pantou A, Tsioulou P, Maziotis E, Rapani A, Giannelou P, Nitsos N, Kokkali G, Koutsilieris M, Pantos K. Reactivating Ovarian Function through Autologous Platelet-Rich Plasma Intraovarian Infusion: Pilot Data on Premature Ovarian Insufficiency, Perimenopausal, Menopausal, and Poor Responder Women. J Clin Med. 2020 Jun 10;9(6):1809. doi: 10.3390/jcm9061809.'}, {'pmid': '27571179', 'type': 'BACKGROUND', 'citation': 'Zhai J, Yao G, Dong F, Bu Z, Cheng Y, Sato Y, Hu L, Zhang Y, Wang J, Dai S, Li J, Sun J, Hsueh AJ, Kawamura K, Sun Y. In Vitro Activation of Follicles and Fresh Tissue Auto-transplantation in Primary Ovarian Insufficiency Patients. J Clin Endocrinol Metab. 2016 Nov;101(11):4405-4412. doi: 10.1210/jc.2016-1589. Epub 2016 Aug 29.'}, {'pmid': '38159964', 'type': 'BACKGROUND', 'citation': 'Zeng X, Du L, Yang H, Wang F. Efficacy and safety of recombinant human granulocyte colony-stimulating factor in patients with poor ovarian response: protocol for a multicentre, randomised, controlled trial. BMJ Open. 2023 Dec 30;13(12):e074135. doi: 10.1136/bmjopen-2023-074135.'}, {'pmid': '37209460', 'type': 'BACKGROUND', 'citation': 'Yuan L, Huang W, Bi Y, Chen S, Wang X, Li T, Wei P, Du J, Zhao L, Liu B, Yang Y. G-CSF-mobilized peripheral blood mononuclear cells combined with platelet-rich plasma restored the ovarian function of aged rats. J Reprod Immunol. 2023 Aug;158:103953. doi: 10.1016/j.jri.2023.103953. Epub 2023 May 16.'}, {'pmid': '33311903', 'type': 'BACKGROUND', 'citation': 'Tandulwadkar S, Karthick MS. Combined Use of Autologous Bone Marrow-derived Stem Cells and Platelet-rich Plasma for Ovarian Rejuvenation in Poor Responders. J Hum Reprod Sci. 2020 Jul-Sep;13(3):184-190. doi: 10.4103/jhrs.JHRS_130_19. Epub 2020 Oct 27.'}, {'pmid': '31092698', 'type': 'BACKGROUND', 'citation': 'Sills ES, Wood SH. Autologous activated platelet-rich plasma injection into adult human ovary tissue: molecular mechanism, analysis, and discussion of reproductive response. Biosci Rep. 2019 Jun 4;39(6):BSR20190805. doi: 10.1042/BSR20190805. Print 2019 Jun 28.'}, {'pmid': '35175511', 'type': 'BACKGROUND', 'citation': 'Seckin S, Ramadan H, Mouanness M, Kohansieh M, Merhi Z. Ovarian response to intraovarian platelet-rich plasma (PRP) administration: hypotheses and potential mechanisms of action. J Assist Reprod Genet. 2022 Jan;39(1):37-61. doi: 10.1007/s10815-021-02385-w. Epub 2022 Feb 17.'}, {'pmid': '40587267', 'type': 'BACKGROUND', 'citation': 'Santamaria A, Ballester A, Munoz M. Enhancing oocyte activation in women with ovarian failure: clinical outcomes of the Stem Cell Regenera study using G-CSF mobilization of peripheral blood stem cells and intraovarian injection of stem cell factor-enriched platelet rich plasma in real-world-practice. Aging (Albany NY). 2025 Jun 27;17(6):1571-1580. doi: 10.18632/aging.206274. Epub 2025 Jun 27.'}, {'pmid': '39976580', 'type': 'BACKGROUND', 'citation': 'Roberts LM, Herlihy N, Reig A, Titus S, Garcia-Milian R, Knight J, Yildirim RM, Margolis CK, Cakiroglu Y, Tiras B, Whitehead CV, Werner MD, Seli E. Transcriptomic landscape of cumulus cells from patients <38 years old with a history of poor ovarian response (POR) treated with platelet-rich plasma (PRP). Aging (Albany NY). 2025 Feb 18;17(2):431-447. doi: 10.18632/aging.206202. Epub 2025 Feb 18.'}, {'pmid': '33896920', 'type': 'BACKGROUND', 'citation': 'Reig A, Herraiz S, Pellicer A, Seli E. Emerging follicular activation strategies to treat women with poor ovarian response and primary ovarian insufficiency. Curr Opin Obstet Gynecol. 2021 Jun 1;33(3):241-248. doi: 10.1097/GCO.0000000000000703.'}, {'pmid': '33716956', 'type': 'BACKGROUND', 'citation': 'Polonio AM, Garcia-Velasco JA, Herraiz S. Stem Cell Paracrine Signaling for Treatment of Premature Ovarian Insufficiency. Front Endocrinol (Lausanne). 2021 Feb 24;11:626322. doi: 10.3389/fendo.2020.626322. eCollection 2020.'}, {'pmid': '36710157', 'type': 'BACKGROUND', 'citation': 'Pellicer N, Cozzolino M, Diaz-Garcia C, Galliano D, Cobo A, Pellicer A, Herraiz S. Ovarian rescue in women with premature ovarian insufficiency: facts and fiction. Reprod Biomed Online. 2023 Mar;46(3):543-565. doi: 10.1016/j.rbmo.2022.12.011. Epub 2022 Dec 20.'}, {'pmid': '34043484', 'type': 'BACKGROUND', 'citation': 'Orive G, Anitua E. Platelet-rich therapies as an emerging platform for regenerative medicine. Expert Opin Biol Ther. 2021 Dec;21(12):1603-1608. doi: 10.1080/14712598.2021.1936495. Epub 2021 Jun 7.'}, {'pmid': '38139165', 'type': 'BACKGROUND', 'citation': 'Nagy B, Kovacs K, Sulyok E, Varnagy A, Bodis J. Thrombocytes and Platelet-Rich Plasma as Modulators of Reproduction and Fertility. Int J Mol Sci. 2023 Dec 11;24(24):17336. doi: 10.3390/ijms242417336.'}, {'pmid': '40379042', 'type': 'BACKGROUND', 'citation': 'Molinaro P, Ballester A, Garcia-Velasco JA, Munoz M, Herraiz S. Impact of bilateral intraovarian platelet-rich plasma in women with poor ovarian response or primary ovarian insufficiency: a retrospective study. Fertil Steril. 2025 Sep;124(3):496-505. doi: 10.1016/j.fertnstert.2025.05.143. Epub 2025 May 14.'}, {'pmid': '27183986', 'type': 'BACKGROUND', 'citation': 'Marchesi F, Mengarelli A. Biosimilar Filgrastim in Autologous Peripheral Blood Hematopoietic Stem Cell Mobilization and Post-Transplant Hematologic Recovery. Curr Med Chem. 2016;23(21):2217-29. doi: 10.2174/0929867323666160517115907.'}, {'pmid': '36706857', 'type': 'BACKGROUND', 'citation': 'Marchante M, Buigues A, Ramirez-Martin N, Martinez J, Pellicer N, Pellicer A, Herraiz S. Single intraovarian dose of stem cell- and platelet-secreted factors mitigates age-related ovarian infertility in a murine model. Am J Obstet Gynecol. 2023 May;228(5):561.e1-561.e17. doi: 10.1016/j.ajog.2023.01.018. Epub 2023 Jan 24.'}, {'pmid': '10725781', 'type': 'BACKGROUND', 'citation': 'Macklon NS, Fauser BC. Aspects of ovarian follicle development throughout life. Horm Res. 1999;52(4):161-70. doi: 10.1159/000023456.'}, {'pmid': '18639875', 'type': 'BACKGROUND', 'citation': 'Kyrou D, Kolibianakis EM, Venetis CA, Papanikolaou EG, Bontis J, Tarlatzis BC. How to improve the probability of pregnancy in poor responders undergoing in vitro fertilization: a systematic review and meta-analysis. Fertil Steril. 2009 Mar;91(3):749-66. doi: 10.1016/j.fertnstert.2007.12.077. Epub 2008 Jul 21.'}, {'pmid': '40076937', 'type': 'BACKGROUND', 'citation': 'Ivaskiene T, Kaspute G, Bareikiene E, Prentice U. Platelet-Rich Plasma and Electrochemical Biosensors: A Novel Approach to Ovarian Function Evaluation and Diagnostics. Int J Mol Sci. 2025 Mar 5;26(5):2317. doi: 10.3390/ijms26052317.'}, {'pmid': '24476957', 'type': 'BACKGROUND', 'citation': 'Hopman RK, DiPersio JF. Advances in stem cell mobilization. Blood Rev. 2014 Jan;28(1):31-40. doi: 10.1016/j.blre.2014.01.001. Epub 2014 Jan 14.'}, {'pmid': '40635295', 'type': 'BACKGROUND', 'citation': 'Heyn J, Brauninger S, Becker P, Stoeckmann N, Seidl C, Howe S, Daubert S, Furst D, Schrezenmeier H, Bonig H. Healthy volunteer stem cell donors followed up 10 years after stimulation with biosimilar filgrastim. Transfusion. 2025 Aug;65(8):1418-1426. doi: 10.1111/trf.18317. Epub 2025 Jul 9.'}, {'pmid': '29960701', 'type': 'BACKGROUND', 'citation': 'Herraiz S, Romeu M, Buigues A, Martinez S, Diaz-Garcia C, Gomez-Segui I, Martinez J, Pellicer N, Pellicer A. Autologous stem cell ovarian transplantation to increase reproductive potential in patients who are poor responders. Fertil Steril. 2018 Aug;110(3):496-505.e1. doi: 10.1016/j.fertnstert.2018.04.025. Epub 2018 Jun 28.'}, {'pmid': '35645011', 'type': 'BACKGROUND', 'citation': 'Herlihy NS, Seli E. The use of intraovarian injection of autologous platelet rich plasma (PRP) in patients with poor ovarian response and premature ovarian insufficiency. Curr Opin Obstet Gynecol. 2022 Jun 1;34(3):133-137. doi: 10.1097/GCO.0000000000000784.'}, {'pmid': '38725194', 'type': 'BACKGROUND', 'citation': 'Herlihy NS, Cakiroglu Y, Whitehead C, Reig A, Tiras B, Scott RT Jr, Seli E. Effect of intraovarian platelet-rich plasma injection on IVF outcomes in women with poor ovarian response: the PROVA randomized controlled trial. Hum Reprod. 2024 May 9:deae093. doi: 10.1093/humrep/deae093. Online ahead of print.'}, {'pmid': '30725347', 'type': 'BACKGROUND', 'citation': 'Farimani M, Heshmati S, Poorolajal J, Bahmanzadeh M. A report on three live births in women with poor ovarian response following intra-ovarian injection of platelet-rich plasma (PRP). Mol Biol Rep. 2019 Apr;46(2):1611-1616. doi: 10.1007/s11033-019-04609-w. Epub 2019 Feb 5.'}, {'pmid': '35451009', 'type': 'BACKGROUND', 'citation': 'Cozzolino M, Herraiz S, Titus S, Roberts L, Romeu M, Peinado I, Scott RT, Pellicer A, Seli E. Transcriptomic landscape of granulosa cells and peripheral blood mononuclear cells in women with PCOS compared to young poor responders and women with normal response. Hum Reprod. 2022 May 30;37(6):1274-1286. doi: 10.1093/humrep/deac069.'}, {'pmid': '38149997', 'type': 'BACKGROUND', 'citation': 'Buigues A, Ramirez-Martin N, Martinez J, Pellicer N, Meseguer M, Pellicer A, Herraiz S. Systemic changes induced by autologous stem cell ovarian transplant in plasma proteome of women with impaired ovarian reserves. Aging (Albany NY). 2023 Dec 26;15(24):14553-14573. doi: 10.18632/aging.205400. Epub 2023 Dec 26.'}, {'pmid': '33539826', 'type': 'BACKGROUND', 'citation': 'Buigues A, Marchante M, de Miguel-Gomez L, Martinez J, Cervello I, Pellicer A, Herraiz S. Stem cell-secreted factor therapy regenerates the ovarian niche and rescues follicles. Am J Obstet Gynecol. 2021 Jul;225(1):65.e1-65.e14. doi: 10.1016/j.ajog.2021.01.023. Epub 2021 Feb 1.'}, {'pmid': '33975729', 'type': 'BACKGROUND', 'citation': 'Buigues A, Diaz-Gimeno P, Sebastian-Leon P, Pellegrini L, Pellicer N, Pellicer A, Herraiz S. Pathways and factors regulated by bone marrow-derived stem cells in human ovarian tissue. Fertil Steril. 2021 Sep;116(3):896-908. doi: 10.1016/j.fertnstert.2021.04.009. Epub 2021 May 8.'}, {'pmid': '33963408', 'type': 'BACKGROUND', 'citation': 'Atkinson L, Martin F, Sturmey RG. Intraovarian injection of platelet-rich plasma in assisted reproduction: too much too soon? Hum Reprod. 2021 Jun 18;36(7):1737-1750. doi: 10.1093/humrep/deab106.'}, {'pmid': '23505226', 'type': 'BACKGROUND', 'citation': 'Anitua E, Prado R, Azkargorta M, Rodriguez-Suarez E, Iloro I, Casado-Vela J, Elortza F, Orive G. High-throughput proteomic characterization of plasma rich in growth factors (PRGF-Endoret)-derived fibrin clot interactome. J Tissue Eng Regen Med. 2015 Nov;9(11):E1-12. doi: 10.1002/term.1721. Epub 2013 Mar 18.'}, {'pmid': '38423539', 'type': 'BACKGROUND', 'citation': 'Barrenetxea G, Celis R, Barrenetxea J, Martinez E, De Las Heras M, Gomez O, Aguirre O. Intraovarian platelet-rich plasma injection and IVF outcomes in patients with poor ovarian response: a double-blind randomized controlled trial. Hum Reprod. 2024 Apr 3;39(4):760-769. doi: 10.1093/humrep/deae038.'}]}, 'descriptionModule': {'briefSummary': '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.', 'detailedDescription': '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.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT'], 'maximumAge': '43 Years', 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Patients from IVI Alicante who decide to undergo the ovarian reactivation treatment "StemCell Regenera" at the clinic for improving ovarian function', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients aged between 18 and 43.\n* Patients diagnosed with poor ovarian response (POR) or low ovarian reserve according to Bolonia criteria (ESHRE).\n* Patients who are indicated for a StemCell Regenera procedure with the use of granulocyte colony-stimulating factors (Filgrastim).\n* Patients who agree to participate and sign the informed consent form.\n\nExclusion Criteria:\n\n* Patients over the age of 43.\n* Patients with only one ovary.\n* Patients with an autoimmune or haematological disorder.\n* Patients currently undergoing treatment with anticoagulant drugs.\n* Patients who are allergic to Filgrastim, the granulocyte colony-stimulating factor.'}, 'identificationModule': {'nctId': 'NCT07376460', 'briefTitle': 'Proteomic and Biological Characterisation of Plasma for the Study of Changes Following Ovarian Reactivation Treatment', 'organization': {'class': 'OTHER', 'fullName': 'Instituto Valenciano de Infertilidad, IVI Alicante'}, 'officialTitle': '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', 'orgStudyIdInfo': {'id': '2510-ALC-124-MM'}}, 'armsInterventionsModule': {'armGroups': [{'label': '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.', 'interventionNames': ['Combination Product: Platelet Rich Plasma + BMDSCs mobilization']}], 'interventions': [{'name': 'Platelet Rich Plasma + BMDSCs mobilization', 'type': 'COMBINATION_PRODUCT', 'description': '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.', 'armGroupLabels': ['Poor responders undergoing ovarian reactivation StemCell Regenera']}]}, 'contactsLocationsModule': {'locations': [{'zip': '03015', 'city': 'Alicante', 'state': 'Alicante', 'country': 'Spain', 'contacts': [{'name': 'Manuel Muñoz Cantero, MD', 'role': 'CONTACT', 'email': 'manuel.munoz@ivirma.com', 'phone': '+34 966 012 490'}], 'facility': 'IVIRMA Alicante', 'geoPoint': {'lat': 38.34517, 'lon': -0.48149}}], 'centralContacts': [{'name': 'Manuel Muñoz Cantero, MD', 'role': 'CONTACT', 'email': 'Manuel.Munoz@ivirma.com', 'phone': '+34 966012490'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Instituto Valenciano de Infertilidad, IVI Alicante', 'class': 'OTHER'}, 'collaborators': [{'name': 'BTI Biotechnology Institute S.L', 'class': 'UNKNOWN'}, {'name': 'Fundación IVI', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}