Clinical Trial Details
— Status: Completed
Administrative data
| NCT number |
NCT02622347 |
| Other study ID # |
rFSH Spiking Experiment |
| Secondary ID |
|
| Status |
Completed |
| Phase |
N/A
|
| First received |
December 2, 2015 |
| Last updated |
May 15, 2017 |
| Start date |
August 2015 |
| Est. completion date |
April 2017 |
Study information
| Verified date |
May 2017 |
| Source |
UMC Utrecht |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Observational [Patient Registry]
|
Clinical Trial Summary
The purpose of this study is to test the validity of our in-house chemiluminescence assay
for measurement of folliclestimulating hormone (FSH) serum levels before and during
exogenous recombinant FSH (rFSH) administration.
Description:
Study question Does our in-house Beckman-Coulter Unicel DXi800 (Woerden, the Netherlands)
chemiluminescence assay completely and consistently recover added known quantities of FSH on
top of a known basal serum FSH concentration?
Spiking-recovery experiment The investigators propose a spiking-recovery experiment in which
30 serum samples of different women with basal FSH concentration varying between 0-14 IU/L
will be divided into two equal volume parts and spiked with a specific concentration of rFSH
(Gonal-F, follitropin alpha; Merck Serono) which will provide a calculated rise in FSH
concentration similar to in vivo serum levels.
To perform more reliable testing, the samples will be tested over multiple days.
Basal FSH spiking experiment In the table below an example is given of different basal FSH
levels spiked with rFSH diluted 2000 times and the theoretical rise in serum that should be
established.
Gonal F concentration is 600 U/L but this concentration unit cannot directly be compared to
the units used for the for the routine serum FSH measurement (IU/L). From a pilot experiment
the investigators know that on average 60% of rFSH is picked up by the Beckman-Coulter
assay.
Buffer spiking In order to determine whether recovery is also influenced by properties of
blood serum, the investigators will conduct another spiking experiment in which different
concentrations of rFSH will be added to an amount of buffer, with no basal [FSH]; 0,1 M
phosphate buffer, pH 7.4 with 1-2% of bovine serum albumin (BSA). A calibration line will be
constructed with 6 concentrations of recF: range 0-40 U/L.
