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

NCT06975683 | Recruiting

• 2 other identifiers: URA-PRGF-012024-514444-87-00
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

Brief 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

Outcome Measures

Primary Outcomes (9)

• 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

Study Arms (1)

Patients starting ovarian stimulation cycle for FIV-ICSI cycle

EXPERIMENTAL

Biological: Plasma Rich in Growth Factors (PRGF)

Interventions

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.

Patients starting ovarian stimulation cycle for FIV-ICSI cycle

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Women of childbearing age as defined by the CTFG\*.
• Women in group 3 and 4 of the POSEIDON classification for low reserve:
• POSEIDON 3: patients ˂ 35 years of age with decreased ovarian reserve (AMH \<1.2 ng/ml, AFC \<5).
• POSEIDON 4: patients ≥ 35 years with decreased ovarian reserve (AMH \<1.2 ng/ml, AFC \<5).
• Patients with at least one ovary.
• Infertility of more than 1 year duration.
• Provision of safe ovarian access on the day of the puncture.
• They agree to participate and to give their written consent.

You may not qualify if:

• Have a diagnosis of clinical ovarian insufficiency - Patients with an ongoing pregnancy - Patients with a clinical diagnosis of ovarian failure
• Patients with ongoing pregnancy
• Current or previous IgA deficiency,
• Ovarian failure secondary to identified genetic causes.
• Presence of pelvic adhesions after abdominal surgery.
• Chronic use of aspirin, NSAIDs or anticoagulants.
• Diseases that alter platelet number or function.
• Psychiatric disorder that precludes participation in the study (including active substance abuse or dependence).
• Obesity (BMI ≥ 30).
• Current female smokers (≥ 15 cigarettes per day) - Current smoking (≥ 15 cigarettes per day)
• Patients affected by neoplastic disease
• Severe male factor infertility

Sponsors & Collaborators

• Instituto de Investigación Sanitaria de la Fundación Jiménez Díaz: lead

Study Sites (1)

Hospital Universitario Fundación Jiménez Diaz

Madrid, 28924, Spain

RECRUITING

MeSH Terms

Interventions

Intercellular Signaling Peptides and Proteins

Intervention Hierarchy (Ancestors)

Peptides; Amino Acids, Peptides, and Proteins; Proteins; Biological Factors

Central Study Contacts

Carlos Javier Valdera Simbron

CONTACT

915504800; carlos.valdera@fjd.es

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Quasi-Experimental Study with Pre-Post Comparison

Study Record Dates

• First Submitted: March 10, 2025
• First Posted: May 16, 2025
• Study Start: May 30, 2025
• Primary Completion: May 1, 2026
• Study Completion: May 1, 2026
• Last Updated: June 12, 2025

Record last verified: 2025-06

Locations

ES (1)