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| ID | Type | Description | Link |
|---|---|---|---|
| 2024-514444-87-00 | EU Trial (CTIS) Number |
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The use of plasma rich in growth factors (PRGF) improves ovarian reserve markers and IVF laboratory parameters in women with low ovarian reserve.
Primary objective To compare ovarian reserve markers and IVF-ICSI laboratory results before and after PRGF infusion.
Secondary Objectives
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Patients starting ovarian stimulation cycle for FIV-ICSI cycle | Experimental |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Plasma Rich in Growth Factors (PRGF) | Biological | On the day of the ovarian puncture of the 1st IVF cycle, intraovarian instillation of plasma rich in growth factors will be performed. |
| Measure | Description | Time Frame |
|---|---|---|
| Number of cycles cancelled pre-puncture | Day 1 | |
| Ovarian reserve markers | Day 1 vs visit 4 weeks | |
| Number of cycles cancelled post-puncture | visit 4 weeks and visit 8 weeks | |
| Number of oocytes recovered | visit 4 weeks and visit 8 weeks | |
| Number of MII (metaphase II stage oocyte) on the day of the puncture | visit 2, day of the puncture (from the first day of menstruation, approximately 22 days later) | |
| Number of fertilised oocytes | visit 4 weeks and visit 8 weeks | |
| Number of embryos obtained per EOC (ovarian stimulation) cycle | visit 4 weeks and visit 8 weeks | |
| Number of embryos of good quality (A or B quality according to ASEBIR classification). | visit 4 weeks and visit 8 weeks | |
| Number of frozen embryos | visit 4 weeks and visit 8 weeks |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Carlos Javier Valdera Simbron | Contact | 915504800 | 3274 | carlos.valdera@fjd.es |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hospital Universitario Fundación Jiménez Diaz | Recruiting | Madrid | 28924 | Spain |
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Quasi-Experimental Study with Pre-Post Comparison
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| ID | Term |
|---|---|
| D036341 | Intercellular Signaling Peptides and Proteins |
| ID | Term |
|---|---|
| D010455 | Peptides |
| D000602 | Amino Acids, Peptides, and Proteins |
| D011506 | Proteins |
| D001685 | Biological Factors |
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