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“Pilot, open, non-comparative study to evaluate the safety and efficacy of Factor-Rich Plasma Intraovarian Growth in Patients with Low Reserve Ovarian”

Status
Recruiting
Phases
Phase 2
Study type
Interventional
Source
EU CTIS
Registry ID
CTIS2024-514444-87-00
Acronym
URA-PRGF-01
Enrollment
50
Registered
2024-10-24
Start date
2025-05-29
Completion date
Unknown
Last updated
2024-11-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Low Reserve Ovarian

Brief summary

Compare ovarian reserve markers before and after surgery. intervention: FSH (continuous quantitative variable); LH (continuous quantitative variable); Estradiol (continuous quantitative variable); AMH (continuous quantitative variable); RFA (discrete quantitative variable), Compare results obtained in the IVF-ICSI laboratory before and after PRP infusion: Number of canceled pre-puncture cycles; Number of cycles canceled post-puncture; Number of oocytes recovered; Number of MII on the day of puncture; Number of fertilized oocytes; Number of embryos achieved per EOC cycles; Number of good quality embryos (quality A or B depending ASEBIR classification); Number of frozen embryos

Detailed description

Compare pregnancy rates and collect pre-post treatment pregnancy-related complications:Number of pregnancies per cycle started; Number of pregnancies per transfer; Number of abortions; Frequency of twin pregnancy; Frequency of hemoperitoneum; Frequency of post-puncture infection, Endpoints necessary by testing the hypothesis: Causes of sterility; Time of sterility in years; Number of embryos transferred (1 or 2); Stage of transferred embryos; EOC days; Total dose of gonadotropins

Interventions

Sponsors

Instituto De Investigacion Sanitaria Fundacion Jimenez Diaz
Lead SponsorOTHER

Eligibility

Sex/Gender
All
Age
18 Years to 64 Years

Design outcomes

Primary

MeasureTime frame
Compare ovarian reserve markers before and after surgery. intervention: FSH (continuous quantitative variable); LH (continuous quantitative variable); Estradiol (continuous quantitative variable); AMH (continuous quantitative variable); RFA (discrete quantitative variable), Compare results obtained in the IVF-ICSI laboratory before and after PRP infusion: Number of canceled pre-puncture cycles; Number of cycles canceled post-puncture; Number of oocytes recovered; Number of MII on the day of puncture; Number of fertilized oocytes; Number of embryos achieved per EOC cycles; Number of good quality embryos (quality A or B depending ASEBIR classification); Number of frozen embryos

Secondary

MeasureTime frame
Compare pregnancy rates and collect pre-post treatment pregnancy-related complications:Number of pregnancies per cycle started; Number of pregnancies per transfer; Number of abortions; Frequency of twin pregnancy; Frequency of hemoperitoneum; Frequency of post-puncture infection, Endpoints necessary by testing the hypothesis: Causes of sterility; Time of sterility in years; Number of embryos transferred (1 or 2); Stage of transferred embryos; EOC days; Total dose of gonadotropins

Countries

Spain

Outcome results

None listed

Source: EU CTIS · Data processed: Feb 4, 2026