Clinical trial 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
Official title: Open, Non-comparative, Pilot Study to Evaluate the Safety and Efficacy of Intraovarian Growth Factor-rich Plasma in Patients With Low Ovarian Reserve
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Low Ovarian Reserve
Lead sponsor: Instituto de Investigación Sanitaria de la Fundación Jiménez Díaz
Sponsor class: OTHER
First posted: 2025-05-16
Enrollment: 50
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: Quasi-Experimental Study with Pre-Post Comparison
Primary purpose: OTHER

Brief 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 criteria: 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 outcomes:
measure: Number of cycles cancelled pre-puncture
timeFrame: Day 1
measure: Ovarian reserve markers
timeFrame: Day 1 vs visit 4 weeks
measure: Number of cycles cancelled post-puncture
timeFrame: visit 4 weeks and visit 8 weeks
measure: Number of oocytes recovered
timeFrame: visit 4 weeks and visit 8 weeks
measure: Number of MII (metaphase II stage oocyte) on the day of the puncture
timeFrame: visit 2, day of the puncture (from the first day of menstruation, approximately 22 days later)
measure: Number of fertilised oocytes
timeFrame: visit 4 weeks and visit 8 weeks
measure: Number of embryos obtained per EOC (ovarian stimulation) cycle
timeFrame: visit 4 weeks and visit 8 weeks
measure: Number of embryos of good quality (A or B quality according to ASEBIR classification).
timeFrame: visit 4 weeks and visit 8 weeks
measure: Number of frozen embryos
timeFrame: visit 4 weeks and visit 8 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Madrid
country: Spain
facility: Hospital Universitario Fundación Jiménez Diaz
Study officials:
References: