Infertility Clinical Trial
Official title:
The Early Luteal Progesterone Profile in IVF Patients Triggered With hCG - a Pilot Study
This pilot-study will help characterize the serum progesterone profiles in IVF patients and correlate progesterone levels to ovarian follicles obtained after stimulation with exogenous gonadotropins.
The early luteal progesterone profile in IVF differs significantly from the progesterone
profile of the natural cycle, in which the peak is reached around the time of implantation.
With this non-invasive trial investigators wish to further explore the early luteal phase
profiles of progesterone and hCG in order to optimize current luteal phase support policies
in IVF and hopefully increase ongoing pregnancy rates.
Stimulation, monitoring, and oocyte pick-up will be performed according to the standard
procedure of the clinic. On the day of trigger with 5.000 IU hCG a blood sample will be
drawn prior to triggering for subsequent analysis. Moreover, all ovarian follicles on each
side equal to or above 11 mm will be registered. Oocyte pick-up and timing of the trigger
bolus will be performed according to the standard procedures of the unit.
A total 10 blood samples will be drawn during this trial - please see "blood sampling".
Blood samples will be collected on the following days for subsequent analysis of LH, E2, hCG
and progesterone.
All embryos will be cryo-preserved for transfer in subsequent frozen/thaw embryo transfer
cycles.
Primary endpoint Serum concentrations of progesterone, LH, E2, and hCG during early luteal
phase.
Secondary endpoints The correlation between follicles ≥ 11 mm and progesterone in early
luteal phase
Data are analyzed using SPSS version 20 software. All tests are two tailed, and P<0.05 is
considered statistically significant. Continuous variables are presented as mean +/- SD and
are tested by student's t-test. Categorical data are expressed as numbers and compared using
the Chi-square test.
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