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

NCT ID: NCT06975683

Last Updated: 2025-06-12

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 50 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-05-30
• Study Completion Date: 2026-05-31

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

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: OTHER
• Blinding Strategy: NONE

Study Groups

Patients starting ovarian stimulation cycle for FIV-ICSI cycle

Group Type: EXPERIMENTAL

Plasma Rich in Growth Factors (PRGF)

Intervention Type: BIOLOGICAL

On the day of the ovarian puncture of the 1st IVF cycle, intraovarian instillation of plasma rich in growth factors will be performed.

Interventions

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.

Intervention Type: BIOLOGICAL

Eligibility Criteria

Inclusion Criteria

• 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.

Exclusion Criteria

• 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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 50 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Instituto de Investigación Sanitaria de la Fundación Jiménez Díaz

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Hospital Universitario Fundación Jiménez Diaz

Madrid, , Spain

Site Status: RECRUITING

Countries

Spain

Central Contacts

Carlos Javier Valdera Simbron

Role: CONTACT

carlos.valdera@fjd.es

915504800 ext. 3274

Facility Contacts

Eva Cerezo Martín

Role: primary

eva.cerezo@quironsalud.es

915504800

Other Identifiers

2024-514444-87-00

Identifier Type: CTIS

Identifier Source: secondary_id

URA-PRGF-01

Identifier Type: -

Identifier Source: org_study_id