Platelet concentrate for Female infertility | Low ovarian reserve

Inclusion criteria

• {"criterion_text":"- Women with a diagnosis of low ovarian response according to POSEIDON III/IV criteria.\n- Age limited to between 18 and 42 years, inclusive\n- Regular cycles, on a monthly basis with an interval of 24 to 35 days.\n- Treatments limited to a single IVF/IVF PGT-A cycle, in which there will be no oocyte/embryo accumulation.\n- Normal karyotypes in both partners.\n- Complete preoperative blood work valid for 6 months according to standard clinical practice, with a minimum platelet count >160,000/mcL.\n- Negative serologies for HIV, HCV, HBV and RPR less than <3 months old. In case of not having a recent test, it will be performed at the in-study research centre at no cost to the patient.\n- Semen with a sperm count greater than 5 million motile sperm per ejaculate or sperm donation treatments.\n- Both ovaries accessible for vaginal puncture\n- BMI >18 kg/m2"}

Exclusion criteria

• {"criterion_text":"- Diagnosis of ovarian failure or amenorrhoeic blips\n- Failure to meet POSEIDON III/IV criteria\n- Presence of autoimmune pathology, thrombophilias, use of anticoagulants or antiplatelet agents or history of cancer treatment (chemotherapy/radiotherapy)\n- Platelets with levels below 160xmcL, aplastic anaemia or thrombocytosis.\n- Presence of ovarian and/or tubal pathology; patients with a single ovary, previous ovarian surgery, hydrosalpinx, known ovarian endometrioma or dermoid cyst\n- BMI >35 kg/m2\n- Male partner with less than 5 million total motile sperm per ejaculate and/or sample obtained by testicular biopsy.\n- Diagnosis of endometrial insufficiency, which is defined as endometrial thickness equal to or less than 6 mm in the previous cycle and/or presence of persistent endometrial fluid."}

Primary endpoints

• {"endpoint_text":"- number of oocytes retrieved after intraovarian administration of the study treatment, PRGF Endoret® vs. placebo","definition_or_measurement_approach":"Count of oocytes retrieved after intraovarian administration; comparison of mean number of oocytes obtained between PRGF Endoret® and placebo (quantify mean difference)."}

Spain

Earliest CTIS Part Ii Submission Date

07-05-2025

Latest Decision Or Authorization Date

30-07-2025

Processing Time Days

84

Number Of Sites

3

Number Of Participants

160

Primary sponsor

Full Name

Ivi Alicante S.L.

Organisation Type

Hospital/Clinic/Other health care facility

Country Of Registered Address

Spain

Third parties

• {"country":"","full_name":"BTI Biotechnology Institute","duties_or_roles":"Source of monetary support","organisation_type":""}