Clinical Trial Details
— Status: Completed
Administrative data
NCT number |
NCT05493202 |
Other study ID # |
SAUCE |
Secondary ID |
|
Status |
Completed |
Phase |
|
First received |
|
Last updated |
|
Start date |
February 20, 2022 |
Est. completion date |
July 30, 2022 |
Study information
Verified date |
August 2022 |
Source |
Olive Fertility Centre |
Contact |
n/a |
Is FDA regulated |
No |
Health authority |
|
Study type |
Observational
|
Clinical Trial Summary
To determine if measurement of urinary estrone glucuronide concentrations with an at-home
device is correlated with superovulatory response during gonadotropin stimulated IVF cycles.
Description:
Hypothesis
Urinary estradiol concentrations measured with an at-home device correlates with gonadotropin
response during superovulation for IVF and can serve as an alternative to serum estradiol
measurements.
Justification
The in vitro fertilization (IVF) process entails gonadotropin stimulation to obtain
supernumerary oocytes. To ensure an adequate and safe administration, gonadotropin treatment
requires monitoring with transvaginal sonography (TVS) to determine the quantity and size of
ovarian follicles. In addition, serum estradiol (E2) concentration reflects bioactivity of
the follicles and is used to modulate dosing. TVS and E2 are complementary modalities used
synchronously to dynamically optimize the gonadotropin protocol. For the typical IVF
stimulation cycle with an GnRH antagonist protocol, the patient will require 10-12 days of
gonadotropin administration, during which time the 3-6 visits for TVS and blood tests will be
needed.
Reducing the invasiveness of procedures can improve the patient experience. Repetitive
phlebotomy, as is required for serum estradiol measurements during IVF, can be unpleasant and
painful. Thus, a less invasive alternative with at-home urinary testing may be more desirable
and convenient.
Estrone glucuronide (E3G) is a metabolite of E2 that can be measured in the urine. Urinary
E3G with an FDA and CE registered home device called the Mira Fertility Tracker ("Mira").
Correlation between the serum hormones and their respective urinary metabolites has been
established but the efficacy of monitoring urinary E3G has not been demonstrated in the
context of IVF.
The purpose of the current observational study is to compare urinary E3G with traditional
serum E2 monitoring during gonadotropin stimulation for IVF and correlate the levels with
stimulation outcomes. If validated, urinary hormone monitoring could serve as a more
patient-friendly alternative to repetitive phlebotomy required for serum hormone measurement
during IVF.
Research Design
Patients will undergo IVF per clinical indication. Gonadotropin dosing will be determined at
the discretion of the responsible physician using standard dosing criteria (age, ovarian
reserve testing, prior history, etc). For consistency of comparison, the study population
will focus on patients with a normal ovarian reserve (AMH 1-3.5ng/mL).
During stimulation, the monitoring schedule will be consistent with routine clinical
protocols. In general, the initial E2 are determined on day 6 of stimulation from a single
serum sample, and subsequent serum E2 and TVS are checked from day 8 onwards, as is
clinically indicated by patient response to gonadotropin stimulation.
Urinary E3G will be monitored daily with first morning urine from the first day through the
final day of gonadotropin stimulation. A Mira device and testing wands will be provided to
each participating patient and urinary testing will be performed by the patient at home.
Primary outcomes will include correlation of E3G with the number of total and mature oocytes
retrieved, and a comparison to the serum E2 correlation to the same parameters. Secondary
outcomes will include correlation of urinary E3G and serum E2 levels throughout stimulation.
Additional details regarding laboratory study protocols are as follows:
Measurement of urine E3G: The Mira be used to measure urinary E3G via immunofluorescence
method. First morning urine will be collected by the patient at home. A test wand will be
dipped into the urine sample for ten seconds, then inserted into a palm-sized device.
All other protocols are consistent with routine clinical practice. Briefly, serum samples for
E2 will be collected by venipuncture and processed using a commercially available E2
chemiluminescent assay on automated immunoanalyzer (Beckman-Coulter Access 2) in an
accredited commercial laboratory (Novavita, Vancouver, BC). Sonography will be performed by
licensed physicians with an endovaginal probe, consistent with standard clinical practice.
IVF laboratory procedures will be performed by trained embryologists at the Olive Fertility
Centre (Vancouver, BC).