Actively Recruiting

Phase Not Applicable
Age: 18Years - 50Years
FEMALE
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

Led by Instituto de Investigación Sanitaria de la Fundación Jiménez Díaz · Updated on 2025-06-12

50

Participants Needed

1

Research Sites

48 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

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

Official Title

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

Who Can Participate

Age: 18Years - 50Years
FEMALE

Eligibility Criteria

Eligible

You may qualify if you...

  • Women of childbearing age as defined by the CTFG.
  • Women in group 3 and 4 of the POSEIDON classification for low ovarian 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.
Not Eligible

You will not qualify if you...

  • Diagnosis of clinical ovarian insufficiency or ovarian failure.
  • Ongoing pregnancy.
  • Current or previous IgA deficiency.
  • Ovarian failure due to genetic causes.
  • Presence of pelvic adhesions after abdominal surgery.
  • Chronic use of aspirin, NSAIDs, or anticoagulants.
  • Diseases altering platelet number or function.
  • Psychiatric disorder that prevents study participation (including active substance abuse or dependence).
  • Obesity with BMI  30.
  • Current female smokers of 15 or more cigarettes per day.
  • Patients with neoplastic disease.
  • Severe male factor infertility.

AI-Screening

AI-Powered Screening

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Trial Site Locations

Total: 1 location

1

Hospital Universitario Fundación Jiménez Diaz

Madrid, Spain, 28924

Actively Recruiting

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Research Team

C

Carlos Javier Valdera Simbron

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

NA

Model

SINGLE_GROUP

Primary Purpose

OTHER

Number of Arms

1

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