Proteomic profiling of plasma before and after stem cell mobilization in poor ovarian responders
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
Run by Instituto Valenciano de Infertilidad, IVI Alicante · NCT07376460 · Data updated 2026-11-12
This study tests whether stem cell mobilization changes the protein makeup of platelet-rich plasma used in StemCell Regenera for women with poor ovarian response.
Quick facts
| Study type | Observational |
|---|---|
| Ages | 18 Years to 43 Years |
| Sex | Women only |
| Enrollment | 10 (estimated) |
| Sponsor | Instituto Valenciano de Infertilidad, IVI Alicante Academic / other |
| Locations | 1 site (Alicante, Alicante) |
| Status | Recruiting |
| Started | March 6, 2026 |
| Main results expected | January 2027 |
| Study ends | June 2027 |
| Registry record updated | November 4, 2026 |
| Trial ID | NCT07376460 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Women aged 18–43 with poor ovarian response or low ovarian reserve who are scheduled for StemCell Regenera using G-CSF and consent to participation.
✕Probably not a fit
Patients outside the age range, without POR/low reserve criteria, or not undergoing StemCell Regenera with Filgrastim may not benefit from this study.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This observational study compares the proteomic and biological profiles of PRP/PRGF prepared with the PRGF Endoret kit before and after mobilizing bone marrow stem cells with G-CSF in women with poor ovarian response. It aims to understand how paracrine signals from mobilized CD34+ cells alter PRGF characteristics relevant to ovarian rejuvenation. Researchers will analyze samples for differences in protein content and related biological factors to inform clinical use of StemCell Regenera. The work is conducted at IVI Alicante with collaboration from BTI Biotechnology Institute and Fundación IVI, following regulatory classifications of PRP as a medicinal product. Enrollment targets women aged 18–43 meeting POR or low ovarian reserve criteria and eligible for StemCell Regenera with Filgrastim, subject to informed consent.
Why it matters
Potential benefit: If successful, the study could clarify how stem cell mobilization affects PRGF composition, potentially improving treatment personalization for POR patients.
How similar studies have gone: Previous work has shown that PRP/PRGF composition can vary with processing; this study extends that to assess changes after stem cell mobilization, with limited prior direct comparisons in this context.
Who can join: the full rules
Show full inclusion / exclusion criteria
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.
Where it's running
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IVIRMA Alicante
Alicante, Alicante, Spain Recruiting
Study contacts
- Study coordinator: Manuel Muñoz Cantero, MD
- Email: Manuel.Munoz@ivirma.com
- Phone: +34 966012490
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.