Clinical Trial Details
— Status: Not yet recruiting
Administrative data
| NCT number |
NCT05790655 |
| Other study ID # |
IORG0010499_202301 |
| Secondary ID |
|
| Status |
Not yet recruiting |
| Phase |
N/A
|
| First received |
|
| Last updated |
|
| Start date |
April 1, 2023 |
| Est. completion date |
December 31, 2025 |
Study information
| Verified date |
March 2023 |
| Source |
Generation Next Fertility |
| Contact |
Alicia Broussard, PhD |
| Phone |
3174456958 |
| Email |
a.broussard[@]generationnextfertility.com |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Interventional
|
Clinical Trial 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.
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 mcg/0.5 mL of Ovidrel® will be self-administered subcutaneously (SQ). Based upon the
patient's 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 10,000 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.
