Autologous Intraovarian Platelet Rich Plasma Treatment in Women With Poor Ovarian Response
- Conditions
- Poor Ovarian Reserve
- Interventions
- Biological: Autologous ovarian PRP injection
- Registration Number
- NCT04797377
- Lead Sponsor
- Nadezhda Women's Health Hospital
- Brief Summary
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.
- Detailed Description
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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Female
- Target Recruitment
- 66
- Patients diagnosed with POR based on Bologna criteria and with a history of at least two prior failed ICSI cycles
- A previous assisted reproductive technology cycle with less than 3 oocytes (conventional stimulation protocol) and AFC < 7
- The same ovarian stimulation protocol before and after the PRP treatment
- Age over 46 years,
- Body mass index (BMI) ≥ 30 kg/m2,
- Presence of pregnancy
- Uncontrolled endocrine disorders (polycystic ovary syndrome and others)
- Parental genetic and chromosomal disorders,
- Immunological disorders
- Cancer diagnostics
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Ovarian Reserve Autologous ovarian PRP injection Patients with diminished ovarian reserve or premature ovarian insufficiency
- Primary Outcome Measures
Name Time Method Embryo number 3 months Number of produced embryos per cycle.
Oocyte quality 3 months Oocytes will be classified based on morphological assessment and enumeration of extracytoplasmic anomalies.
Oocyte number 3 months Number of Metaphase II oocyte yield.
Embryo quality 3 months 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.
Fertilization rate 3 months Fertilization rate will be calculated as the percentage of transformation of the injected oocytes into two pronuclei.
- Secondary Outcome Measures
Name Time Method Serum follicle stimulating hormone (FSH) 3 months Serum concentration of follicle stimulating hormone (FSH) levels determined on day 3 of the cycle by an electrochemiluminescent (ECLIA) immunoanalyzer.
Antral follicle count (AFC) 3 months Number of Antral Follicles determined by pelvic sonogram on day 2 or 3 of the cycle.
Serum anti-mullerian hormone (AMH) 3 months Serum concentration of anti-mullerian hormone determined on day 3 of the cycle by an electrochemiluminescent (ECLIA) immunoanalyzer.
Trial Locations
- Locations (1)
Nadezhda Women's Health Hospital
🇧🇬Sofia, Bulgaria