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

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexFemale
Age18-50
SponsorInstituto de Investigación Sanitaria de la Fundación Jiménez Díaz

About this trial

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

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Women of childbearing age as defined by the CTFG*.

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.

Disqualifiers

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.

Trial design

Design model

Single group

Treatments tested in this trial

  • Plasma Rich in Growth Factors (PRGF)

    Biological/Vaccine

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

Treatment groups

50 Participants
are divided into 1 treatment group
Group A: Patients starting ovarian stimulation cycle for FIV-ICSI cycleExperimental treatment 1 intervention

Trial outcomes

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

Secondary outcomes

Other outcomes

Sponsors and contacts

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