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

Instituto de Investigación Sanitaria de la Fundación Jiménez Díaz

Status

Enrolling

Conditions

Low Ovarian Reserve

Treatments

Biological: Plasma Rich in Growth Factors (PRGF)

Study type

Interventional

Funder types

Other

Identifiers

URA-PRGF-01

2024-514444-87-00 (EU Trial (CTIS) Number)

Details and patient eligibility

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

Enrollment

50 estimated patients

Sex

Female

Ages

18 to 50 years old

Volunteers

No Healthy Volunteers

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