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
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.
Study 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
Eligibility
Sex
FEMALE
Min age
18 Years
Max age
50 Years
Healthy volunteers
No
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
Primary outcome measure(s)
Number of cycles cancelled pre-puncture — Day 1
Ovarian reserve markers — Day 1 vs visit 4 weeks
Number of cycles cancelled post-puncture — visit 4 weeks and visit 8 weeks
Number of oocytes recovered — visit 4 weeks and visit 8 weeks
Number of MII (metaphase II stage oocyte) on the day of the puncture — visit 2, day of the puncture (from the first day of menstruation, approximately 22 days later)
Number of fertilised oocytes — visit 4 weeks and visit 8 weeks
Number of embryos obtained per EOC (ovarian stimulation) cycle — visit 4 weeks and visit 8 weeks
Number of embryos of good quality (A or B quality according to ASEBIR classification). — visit 4 weeks and visit 8 weeks
Number of frozen embryos — visit 4 weeks and visit 8 weeks
Trial sites (1)
Facility
City
Region
Status
Hospital Universitario Fundación Jiménez Diaz
Madrid
Spain
Recruiting
More Instituto de Investigación Sanitaria de la Fundación Jiménez Díaz trials in Spain
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
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