Reproductive age women diagnosed with poor ovarian response (POR) based on Bologna criteria with a history of at least two prior failed ICSI 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 both ovaries. Ovarian reserve parameters and ICSI outcomes will be determined.
Reproductive age women diagnosed with POR based on Bologna criteria with a history of at least two prior failed intracytoplasmic sperm injection (ICSI) 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 11.8 inch (30 cm) single lumen 21G needles under transvaginal ultrasound guidance. On the 2 to 4th days of the first three 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 ICSI, followed by embryo transfer. Biomarkers of ovarian reserve (AFC, FSH, AMH), and ICSI outcome parameters (number of metaphase II (MII) oocytes, blastocyst embryos, fertilization rate, oocyte and embryo quality) will be followed.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
66
The same day, within 1 hour of sample preparation, PRP injection will be performed transvaginally under ultrasound guidance and under sedation anesthesia into both ovaries using 11.8 inch (30 cm) single lumen 21G needles. The ovaries will be reached using needle guide preventing vascular or other structures rupture. The needle will be advanced into the centre of the ovarian medula without rotation. The correct tip placement will be confirmed by ultrasound. The activated PRP will be slowly introduced during careful retraction of the needle across the previously traversed ovarian cortex. The final PRP volume will be deposited under the ovarian capsule and the needle exit the ovary. Approximately 0.5 ml 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 minutes and also be discharged home on the same day.
Nadezhda Women's Health Hospital
Sofia, Bulgaria
Oocyte number
Number of Metaphase II oocyte yield.
Time frame: 3 months
Oocyte quality
Oocytes will be classified based on morphological assessment and enumeration of extracytoplasmic anomalies.
Time frame: 3 months
Embryo number
Number of produced embryos per cycle.
Time frame: 3 months
Embryo quality
Morphological evaluation of the cultured embryos will be conducted 120 or 144 hr following sperm injection. Blastocysts scoring will be performed on day 5 or 6 depending on the blastocoel cavity expansion and on the inner cell mass and trophectoderm cells integrity.
Time frame: 3 months
Fertilization rate
Fertilization rate will be calculated as the percentage of transformation of the injected oocytes into two pronuclei.
Time frame: 3 months
Antral follicle count (AFC)
Number of Antral Follicles determined by pelvic sonogram on day 2 or 3 of the cycle.
Time frame: 3 months
Serum anti-mullerian hormone (AMH)
Serum concentration of anti-mullerian hormone determined on day 3 of the cycle by an electrochemiluminescent (ECLIA) immunoanalyzer.
Time frame: 3 months
Serum follicle stimulating hormone (FSH)
Serum concentration of follicle stimulating hormone (FSH) levels determined on day 3 of the cycle by an electrochemiluminescent (ECLIA) immunoanalyzer.
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Time frame: 3 months