Ignite Creation Date:
2024-05-06 @ 2:09 PM
Last Modification Date:
2024-10-26 @ 1:26 PM
Study NCT ID:
NCT04237909
Status:
COMPLETED
Last Update Posted:
2020-11-24
First Post:
2020-01-12
Brief Title:
Effects of Intraovarian Platelet Rich Plasma in Women With Poor Ovarian Response and Premature Ovarian Insufficiency
Sponsor:
Acibadem University
Organization:
Acibadem University
Study Overview
Official Title:
Effects of Intraovarian Injection of Autologous Platelet Rich Plasma on Ovarian Reserve and IVF Outcome Parameters in Women With Premature Ovarian Insufficiency and Poor Ovarian Response
Status:
COMPLETED
Status Verified Date:
2020-11
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 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 2PNpronucleus embryos cleavage stage blastocyst embryos 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