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NCT Number: 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

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

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Key information

Conditions

Low Ovarian Reserve

Age range

18 year–50 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Hospital Universitario Fundación Jiménez Diaz

Madrid, 28924, Spain

Location status: Recruiting

Location contact

Carlos Javier Valdera Simbron

PRINCIPAL_INVESTIGATOR

Eva Cerezo Martín

CONTACT

[email protected]

915504800

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

Primary outcomes

  1. Number of cycles cancelled pre-puncture

    Time frame: Day 1

  2. Ovarian reserve markers

    Time frame: Day 1 vs visit 4 weeks

  3. Number of cycles cancelled post-puncture

    Time frame: visit 4 weeks and visit 8 weeks

  4. Number of oocytes recovered

    Time frame: visit 4 weeks and visit 8 weeks

  5. Number of MII (metaphase II stage oocyte) on the day of the puncture

    Time frame: visit 2, day of the puncture (from the first day of menstruation, approximately 22 days later)

  6. Number of fertilised oocytes

    Time frame: visit 4 weeks and visit 8 weeks

  7. Number of embryos obtained per EOC (ovarian stimulation) cycle

    Time frame: visit 4 weeks and visit 8 weeks

  8. Number of embryos of good quality (A or B quality according to ASEBIR classification).

    Time frame: visit 4 weeks and visit 8 weeks

  9. Number of frozen embryos

    Time frame: visit 4 weeks and visit 8 weeks

Study contacts

Contact information is provided by the study sponsor or research team.

Carlos Javier Valdera Simbron

CONTACT

[email protected]

915504800 ext. 3274

Sponsors and collaborators

Lead sponsor

Instituto de Investigación Sanitaria de la Fundación Jiménez Díaz

Other

Registry information

Official study title

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

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
May 16, 2025
Registry last updated
Jun 12, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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