NCT06975683

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

Open, Non-comparative, Pilot Study to Evaluate the Safety and Efficacy of Intraovarian Growth Factor-rich Plasma in Patients With Low Ovarian Reserve

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 50 (estimated)
• Sponsor: Instituto de Investigación Sanitaria de la Fundación Jiménez Díaz · Academic / Other
• Sex: Female
• Age: 18 Years – 50 Years
• Healthy volunteers: Not accepted

Summary

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

Conditions

• Low Ovarian Reserve

Interventions

Type	Name	Description
BIOLOGICAL	Plasma Rich in Growth Factors (PRGF)	On the day of the ovarian puncture of the 1st IVF cycle, intraovarian instillation of plasma rich in growth factors will be performed.

Timeline

• Start date: 2025-05-30
• Primary completion: 2026-05-01
• Completion: 2026-05-01
• First posted: 2025-05-16
• Last updated: 2025-06-12

Locations

1 site across 1 country: Spain