Effects of Intraovarian Platelet Rich Plasma in Women With Poor Ovarian Response and Premature Ovarian Insufficiency
Condition: Premature Ovarian Failure; Diminished Ovarian Reserve
MeSH terms: Premature Birth; Primary Ovarian Insufficiency; Menopause, Premature
Study type: Interventional

Summary: 
      Reproductive age women diagnosed with poor ovarian response (POR) based on Poseidon criteria
      and premature ovarian insufficiency (POI) based on ESHRE criteria and with a history of at
      least one prior failed IVF cycle will be recruited for the study. Antral follicle count
      (AFC), serum anti-mullerian hormone (AMH), and early follicular phase serum follicle
      stimulating hormone (FSH) levels will determined at baseline. Autologous blood obtained from
      peripheral vein will be used to prepare PRP following standard protocols and will be injected
      to at least one ovary. Ovarian reserve parameters and IVF outcomes will be determined.
    

Detailed description: 
      Reproductive age women diagnosed with POR based on Poseidon criteria and POI based on
      European Society of Human Reproduction and Endocrinology (ESHRE) criteria with a history of
      at least one prior failed IVF cycle will recruited for the study. Antral follicle count
      (AFC), serum anti-mullerian hormone (AMH), and early follicular phase serum follicle
      stimulating hormone (FSH) levels will be determined at baseline. Autologous blood obtained
      from peripheral vein will be used to prepare PRP following standard protocols. PRP injection
      will be performed under sedation anesthesia, using a 35 cm 17 G needle under transvaginal
      ultrasound guidance. On the 2-4th days of the first six menstrual cycles following the
      procedure, AFC, AMH, and FSH levels will be re-assessed. Patients with at least one antral
      follicle will be started on ovarian stimulation for in-vitro fertilization- intracytoplasmic
      sperm injection (IVF-ICSI), followed by embryo banking/ preimplantation genetic testing-
      aneuploidy (PGT-A) or embryo transfer. Markers of ovarian reserve (AFC, FSH, AMH), and IVF
      laboratory outcome parameters (number of metaphase II (MII) oocytes, 2PN(pronucleus) embryos,
      cleavage stage, blastocyst embryos) will be followed.
    

Intervention name(s): PRP injection into at least one ovary
Intervention type(s): Biological
Intervention description(s): The same day, within 2 hours of sample preparation, PRP injection will be performed transvaginally under ultrasound guidance and under sedation anesthesia into at least one ovary using a 35 cm 17 G single lumen needle. The injection will be done underneath the ovarian cortex to the subcortical and stromal areas. Approximately 2-4cc of the PRP solution will be injected into each ovary. After the procedure, the patients will be taken to the recovery room and will be observed for 30-40 minutes and also be discharged home on the same day.
Intervention model: Single Group Assignment
Intervention model description: After the couples are recruited for the study, Antral follicle count (AFC), serum anti-mullerian hormone (AMH) and follicle stimulating hormone (FSH) levels will be determined at baseline and will be repeated beginning with the first menstrual cycle. Approximately 20 ml of blood sample will be collected under sterile conditions, and PRP will be prepared. The same day, within 2 hours of sample preparation, PRP injection will be performed transvaginally under ultrasound guidance and under sedation anesthesia into at least one ovary Ovarian reserve (AFC, FSH, AMH), and IVF laboratory outcome parameters (number of MII oocytes, 2PN embryos, cleavage stage embryos) will be followed for six sequential months. Spontaneous pregnancies will also be recorded.
Masking: None (Open Label)
Primary purpose: Treatment