Ignite Creation Date:
2024-05-06 @ 6:49 PM
Last Modification Date:
2024-10-26 @ 2:55 PM
Study NCT ID:
NCT05790655
Status:
NOT_YET_RECRUITING
Last Update Posted:
2023-03-30
First Post:
2023-03-06
Brief Title:
Ovarian PRP for Diminished Ovarian Reserve
Sponsor:
Generation Next Fertility
Organization:
Generation Next Fertility
Study Overview
Official Title:
Ovarian Platelet-Rich Plasma Injections for Diminished Ovarian Reserve Patients A Double-Blinded Placebo-Control Trial
Status:
NOT_YET_RECRUITING
Status Verified Date:
2023-03
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:
oPRP
Brief Summary:
This prospective double-blinded randomized placebo control study aims to determine if In Vitro Fertilization IVF outcomes are improved by ovarian platelet-rich plasma injections oPRP for women diagnosed with diminished ovarian reserve DOR Women with DOR notoriously have the lowest chance of pregnancy and live birth compared to age-matched peers with a normal or robust ovarian reserve
Detailed Description:
A randomized double-blind placebo-controlled trial comparing ovarian injection of platelet-rich plasma vs placebo in women diagnosed with diminished ovarian reserve at risk for a poor ovarian response POR between 35 to 42 years of age Participants for this study include patients who are planning to undergo IVF with preimplantation genetic testing for aneuploidy PGT-A followed by a frozen embryo transfer FET cycle Only patients with either a euploid embryo or eligible mosaic embryo following consultation with a geneticist as determined by PGT-A will be allowed to proceed with a single blastocyst FET cycle
All patients will have a baseline ultrasound and blood work at the time of menses approximately one month prior to starting their initial IVF cycle Routine monitoring will be required to determine the day of ovulation Once an LH surge is detected or if a lead follicle on pelvic ultrasound is deemed large enough to induce ovulation a trigger shot with 250 mcg05 mL of Ovidrel will be self-administered subcutaneously SQ Based upon the patients randomization either oPRP or ovarian Serum oS injections will be performed under anesthesia and within 72 hours from the day of ovulation Following their ovarian injections all patients will return for monitoring with the onset of menses approximately 14 to 16 days from the date of ovulation
A medication protocol will be determined at the start of each IVF cycle Either a natural nIVF mild mIVF or conventional cIVF IVF protocol will be chosen by the treating physician This determination will be based on findings from the repeat pelvic ultrasound with AFC and blood work for anti-mullerian hormone AMH follicle stimulating hormone FSH lutenizing hormone LH estradiol E2 progesterone P4 and beta-human chorionic gonadotrophin B-hCG Natural IVF will be considered for patients with only 1-2 antral follicles mIVF for patients with 2-4 antral follicles observed and cIVF for patients with four or more antral follicles visualized at the time stimulation started
Patients will begin their designated protocol and return four to five days following medication start A repeat pelvic ultrasound will be performed to measure the growth and size of all follicles visualized along with the endometrial thickness Also blood work for E2 FSH LH and P4 will be obtained Monitoring for follicular and endometrial development will continue routinely and as needed until the majority of all follicles observed have a mean diameter between 15 to 22 mm Induction of ovulation will commence 35 and a half hours prior to oocyte retrieval by self-administration of 10000 IU hCG SQ
The patient will receive deep IV sedation anesthesia by a board-certified anesthesiologist for her oocyte retrieval and placement of either her second oPRP or oS injections Using transvaginal ultrasound guidance all follicles visualized under ultrasound will be aspirated using standard practices by patients undergoing IVF at GNF Aspirates will be collected in 10 ml test tubes All oocytes will be assessed at the time of retrieval for maturity All oocytes that are deemed mature MII will undergo intracytoplasmic sperm injection ICSI to maximize fertilization rates 2-4 hours after identification of the first polar body All immature non MII oocytes will be isolated under a stereomicroscope and transferred into maturation media and incubated further in a triple gas mixture 90 N2 5 CO2 and 5 O2 for up to 24 hours to allow maturation prior to ICSI Following the oocyte retrieval either oPRP or oS will be performed as described previously
Monitoring will recommence two weeks following the first oocyte retrieval to identify if any residual follicles or ovarian cysts are present If the ovaries are deemed resting and no active ovarian cysts persist then the patient will begin her second IVF cycle Again the medication protocol will be determined by findings observed on pelvic ultrasound including AFC and ovarian hormone testing If the patient is deemed ineligible to start another IVF cycle then she will return with the following menstrual period to begin her second IVF cycle The process of monitoring patients inducing ovulation and collecting oocytes will be identical to the first oocyte retrieval However no additional oPRP or oS injections will be performed
All patients will have a baseline ultrasound and blood work at the time of menses approximately one month prior to starting their initial IVF cycle Routine monitoring will be required to determine the day of ovulation Once an LH surge is detected or if a lead follicle on pelvic ultrasound is deemed large enough to induce ovulation a trigger shot with 250 mcg05 mL of Ovidrel will be self-administered subcutaneously SQ Based upon the patients randomization either oPRP or ovarian Serum oS injections will be performed under anesthesia and within 72 hours from the day of ovulation Following their ovarian injections all patients will return for monitoring with the onset of menses approximately 14 to 16 days from the date of ovulation
A medication protocol will be determined at the start of each IVF cycle Either a natural nIVF mild mIVF or conventional cIVF IVF protocol will be chosen by the treating physician This determination will be based on findings from the repeat pelvic ultrasound with AFC and blood work for anti-mullerian hormone AMH follicle stimulating hormone FSH lutenizing hormone LH estradiol E2 progesterone P4 and beta-human chorionic gonadotrophin B-hCG Natural IVF will be considered for patients with only 1-2 antral follicles mIVF for patients with 2-4 antral follicles observed and cIVF for patients with four or more antral follicles visualized at the time stimulation started
Patients will begin their designated protocol and return four to five days following medication start A repeat pelvic ultrasound will be performed to measure the growth and size of all follicles visualized along with the endometrial thickness Also blood work for E2 FSH LH and P4 will be obtained Monitoring for follicular and endometrial development will continue routinely and as needed until the majority of all follicles observed have a mean diameter between 15 to 22 mm Induction of ovulation will commence 35 and a half hours prior to oocyte retrieval by self-administration of 10000 IU hCG SQ
The patient will receive deep IV sedation anesthesia by a board-certified anesthesiologist for her oocyte retrieval and placement of either her second oPRP or oS injections Using transvaginal ultrasound guidance all follicles visualized under ultrasound will be aspirated using standard practices by patients undergoing IVF at GNF Aspirates will be collected in 10 ml test tubes All oocytes will be assessed at the time of retrieval for maturity All oocytes that are deemed mature MII will undergo intracytoplasmic sperm injection ICSI to maximize fertilization rates 2-4 hours after identification of the first polar body All immature non MII oocytes will be isolated under a stereomicroscope and transferred into maturation media and incubated further in a triple gas mixture 90 N2 5 CO2 and 5 O2 for up to 24 hours to allow maturation prior to ICSI Following the oocyte retrieval either oPRP or oS will be performed as described previously
Monitoring will recommence two weeks following the first oocyte retrieval to identify if any residual follicles or ovarian cysts are present If the ovaries are deemed resting and no active ovarian cysts persist then the patient will begin her second IVF cycle Again the medication protocol will be determined by findings observed on pelvic ultrasound including AFC and ovarian hormone testing If the patient is deemed ineligible to start another IVF cycle then she will return with the following menstrual period to begin her second IVF cycle The process of monitoring patients inducing ovulation and collecting oocytes will be identical to the first oocyte retrieval However no additional oPRP or oS injections will be performed
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