Ignite Creation Date:
2024-05-06 @ 3:53 PM
Last Modification Date:
2024-10-26 @ 1:59 PM
Study NCT ID:
NCT04797377
Status:
COMPLETED
Last Update Posted:
2022-04-06
First Post:
2021-03-08
Brief Title:
Autologous Intraovarian Platelet Rich Plasma Treatment in Women With Poor Ovarian Response
Sponsor:
Nadezhda Womens Health Hospital
Organization:
Nadezhda Womens Health Hospital
Study Overview
Official Title:
Effects of Autologous Intraovarian Platelet Rich Plasma in Women With Poor Ovarian Response
Status:
COMPLETED
Status Verified Date:
2022-04
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 118 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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None