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Open, Non-comparative Pilot Study to Evaluate the Safety and Efficacy of Intraovarian Plasma Rich in Growth Factors (PRGF) in Patients With Low Ovarian Reserve

StatusRecruiting
PhaseNot applicable
Started
View on ClinicalTrials.gov ↗
Record status
This record was last updated June 12, 2025 (before its estimated May 2026 completion). Its status may not reflect the trial's current state.

Record History

  1. Trial status: Not Yet Recruiting to Recruiting
    • Start date changed from estimate of May 2025 to May 30, 2025
    • Site details revised
    v3
  2. Re-verified, no change to tracked fieldsv2
  3. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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 * To compare pre- and post-treatment pregnancy rates. * To collect complications associated with the application of intraovarian PRGF. General Outline of the Study VISIT 1 * Patient Selection * Confirm that he/she has all the analyses and variables to be studied. * Signing of Informed Consent * Usual IVF protocol (1st IVF cycle) VISIT 2 * Instillation of intraovarian PRGF on the day of the puncture of the 1st IVF cycle in the FJD VISIT 3 * Analytical control at 4 weeks VISIT 4 * Analytical control at 8 weeks VISIT 5 * In case of failure to achieve gestation Start of 2nd cycle of IVF
Trial Details
NCT Number NCT06975683
Lead Sponsor Instituto de Investigación Sanitaria de la Fundación Jiménez Díaz
Conditions
(from sponsor)		 Low Ovarian Reserve
Enrollment 50 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov