PLATELET CONCENTRATE for Diminished ovarian reserve

Inclusion criteria

• {"criterion_text":"- Women of group 3 and 4 of the POSEIDON classification for low reserve: POSEIDON 3: patients ˂ 35 years of age with diminished ovarian reserve (AMH <1.2 ng/ml, AFC <5). POSEIDON 4: patients ≥ 35 years of age with diminished ovarian reserve (AMH <1.2 ng/ml, AFC <5).\n- Patients with at least one ovary.\n- Infertility for at least one year\n- Forecast of safe ovarian access on the day of puncture.\n- Patients who agree to participate and give their written consent"}

Exclusion criteria

• {"criterion_text":"- Patients with diagnosis of clinical ovarian insufficiency\n- Patients affected by neoplastic disease\n- Infertility with severe male factor\n- Pregnant patients\n- Current or previous IgA deficiency\n- Ovarian failure secondary to identify genetic causes\n- Presence of pelvic adhesions after abdominal surgery\n- Chronic use of aspirin, NSAIDs or anticoagulants\n- Patients with psychiatric disorder precluding participation in the study (including abuse or dependence on psychoactive substances\n- Obesity (BMI ≥ 30)\n- Current cigarettes smoking (≥ 15 cigarettes per day)"}

Primary endpoints

• {"endpoint_text":"- Compare ovarian reserve markers before and after surgery. intervention: FSH (continuous quantitative variable); LH (continuous quantitative variable); Estradiol (continuous quantitative variable); AMH (continuous quantitative variable); RFA (discrete quantitative variable)","definition_or_measurement_approach":"Comparison of ovarian reserve markers measured before and after the intervention; listed markers are measured as quantitative variables (FSH, LH, Estradiol, AMH as continuous; RFA as discrete)."}
• {"endpoint_text":"- Compare results obtained in the IVF-ICSI laboratory before and after PRP infusion: Number of canceled pre-puncture cycles; Number of cycles canceled post-puncture; Number of oocytes recovered; Number of MII on the day of puncture; Number of fertilized oocytes; Number of embryos achieved per EOC cycles; Number of good quality embryos (quality A or B depending ASEBIR classification); Number of frozen embryos","definition_or_measurement_approach":"Laboratory outcomes compared before and after PRGF infusion including counts of cycles, oocytes, MII oocytes, fertilized oocytes, embryos obtained, embryo quality per ASEBIR classification, and frozen embryos."}

Secondary endpoints

• {"endpoint_text":"- Compare pregnancy rates and collect pre-post treatment pregnancy-related complications:Number of pregnancies per cycle started; Number of pregnancies per transfer; Number of abortions; Frequency of twin pregnancy; Frequency of hemoperitoneum; Frequency of post-puncture infection","definition_or_measurement_approach":"Comparison of pregnancy outcomes and collection of pregnancy-related complications pre- and post-treatment, measured as counts and frequencies per cycle/transfer."}
• {"endpoint_text":"- Endpoints necessary by testing the hypothesis: Causes of sterility; Time of sterility in years; Number of embryos transferred (1 or 2); Stage of transferred embryos; EOC days; Total dose of gonadotropins","definition_or_measurement_approach":"Variables collected for hypothesis testing (etiology and duration of sterility, embryo transfer details, stimulation days and total gonadotropin dose) measured as categorical or quantitative variables as applicable."}

Spain

Earliest CTIS Part Ii Submission Date

09-10-2024

Latest Decision Or Authorization Date

13-11-2024

Processing Time Days

35

Number Of Sites

2

Number Of Participants

50

Primary sponsor

Full Name

Instituto De Investigacion Sanitaria Fundacion Jimenez Diaz

Organisation Type

Laboratory/Research/Testing facility

Country Of Registered Address

Spain

Third parties

• {"country":"","full_name":"TheramexHealthcareSpain S.L.","duties_or_roles":"Source of monetary support","organisation_type":""}
• {"country":"","full_name":"BTI BiotechnologyIntitute S.L","duties_or_roles":"Source of monetary support","organisation_type":""}