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AzTrials

Poor Ovarian ResponseNCT07376460

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

An observational study of Poor Ovarian Response and Ovarian Reactivation, run by Instituto Valenciano de Infertilidad, IVI Alicante at 1 site in Spain.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 to 43 years, women only
Conditions the study is for
Poor Ovarian Response, Ovarian Reactivation
What is being tested?
Platelet Rich Plasma + BMDSCs mobilization
How many people
10 participants
Where
1 siteSpain
Study dates
6 Mar 2026to Jun 2027
Phase
Observational
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 43 years
  • Women only
  • No healthy volunteers
  • Adult

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

Who may be able to join

  • 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.

Who cannot join

  • 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 locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Manuel Muñoz Cantero, MD contact

+34 966012490

Manuel.Munoz@ivirma.com

Spain1 site, 1 recruiting
  • IVIRMA Alicante

    Alicante, Alicante, 03015

    Manuel Muñoz Cantero, MD, +34 966 012 490, manuel.munoz@ivirma.com

    Recruiting

Other trials in Spain

About this study

Official title: 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

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.

Read the 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.

Being tested
Platelet Rich Plasma + BMDSCs mobilization
Keywords
Poor ovarian response, ovarian reactivation, StemCell Regenera, ovarian rejuvenation therapy, ovarian failure, Stem cell mobilization, PRP, PRGF, Bone Marrow Derived Stem Cells (BMDSC)

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Platelet Rich Plasma + BMDSCs mobilizationCombination 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.

Study groups in NCT07376460
Study groupRoleWhat they receive
Poor responders undergoing ovarian reactivation StemCell RegeneraWomen 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.
Receives: Combination Product: Platelet Rich Plasma + BMDSCs mobilization

What is being measured

The primary outcome is the main question the study is designed to answer.

  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

    Measured: 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

    Measured: From enrollment to the end of treatment (4 day treatment) at day 5

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted29 Jan 2026
  2. Study start6 Mar 2026
  3. Primary completionJan 2027 (estimated)
  4. Study completionJun 2027 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Other
Time perspective
Prospective
Enrolment
10 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07376460
Sponsor's protocol ID
2510-ALC-124-MM
Status last verified
Nov 2026
First submitted
22 Jan 2026
Last updated
4 Nov 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No

Publications

  • 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.

    PubMed 32532000
  • 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.

    PubMed 27571179
  • 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.

    PubMed 38159964
  • 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.

    PubMed 37209460
  • 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.

    PubMed 33311903
  • 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.

    PubMed 31092698
  • 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.

    PubMed 35175511
  • 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.

    PubMed 40587267
  • 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.

    PubMed 39976580
  • 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.

    PubMed 33896920
  • 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.

    PubMed 33716956
  • 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.

    PubMed 36710157
  • 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.

    PubMed 34043484
  • 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.

    PubMed 38139165
  • 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.

    PubMed 40379042

Questions about this trial

What is this clinical trial studying?

An observational study of Poor Ovarian Response and Ovarian Reactivation, run by Instituto Valenciano de Infertilidad, IVI Alicante at 1 site in Spain.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 4 Nov 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Manuel Muñoz Cantero, MD (+34 966012490, Manuel.Munoz@ivirma.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Biological and proteomic characterisation of the platelet rich plasma (time frame: From enrollment to the end of treatment (4 day treatment) at day 5). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07376460, which also lists 33 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Nov 2026.

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