Infertility Clinical Trial
Official title:
A Pilot Study on the Effect of Ovarian Stimulation With r-hLH/r-hFSH, r-hFSH and hMG in Reducing Apoptosis Rate in Cumulus Cells of Patients Undergoing ICSI
HP-hMG, recombinant FSH (r-hFSH) and a combination of r-hFSH/r-hLH, are commonly used for
ovarian stimulation in infertile women undergoing IVF/ICSI treatments. Several publications
have compared the effectiveness of these compounds, in terms of clinical outcomes.
The aim of our study is to investigate the effects of three different ovarian stimulation
protocols (HP-hMG, r-hFSH and r-hFSH/r-hLH), in a pilot prospective observational study,
evaluating the effects of recombinant LH and extractive hCG (with LH like activity) on the
biological outcome as well as on the clinical outcome. We will use the apoptosis rate of the
cumulus cell, usually discarded after oocyte collection, as molecular biomarker to assess
the oocyte quality, as biological outcome. The clinical outcome was estimated measuring
implantation and ongoing pregnancy rates within and between the three different ovarian
stimulation protocols
HP-hMG, recombinant FSH (r-hFSH) and a combination of r-hFSH/r-hLH, are commonly used for
ovarian stimulation in infertile women undergoing IVF/ICSI treatments. Several publications
have compared the effectiveness of these compounds, in terms of clinical outcomes . Most of
the studies have been performed in women undergoing pituitary down-regulation with a GnRH
agonist long protocol, focusing on the outcome after r-hFSH and HP-hMG ovarian stimulation .
Two meta-analyses showed a better outcome in terms of live birth rate for HP-hMG ovarian
stimulation compared to r-hFSH in the GnRH agonist long protocol. These studies mainly
compare different dose regimen of the two drugs used in the same clinical population, r-hFSH
and HP-hMG. Recently other two clinical randomized studies compared, in a non-inferiority
design, the same dose regimen of the two drugs. The results confirmed non inferiority of the
HP-hMG formulation in terms of pregnancy rate compared to the r-hFSH formulations, but
significantly higher drug consumption and lower yield in oocyte recovery.
In clinical practice HP-hMG is a clinical favored treatment when LH activity is requested
for the ovarian stimulation success, due to LH activity guaranteed by extractive hCG added
to this formulation.
Several studies have addressed the issue of the need or convenience of adding LH activity to
FSH in ovarian stimulation in IVF/ICSI-ET in order to increase clinical outcomes in IVF/ICSI
cycles , but they have not been able to address the role that LH administration plays during
the follicular phase of a stimulated cycle for IVF-ET under pituitary suppression. In the
case of r-hFSH administration, in normo-gonadotrophic patients, low levels of endogenous LH
can persist despite pituitary down-regulation with GnRH analogues. It is known that only 1%
of LH receptors need to be occupied to drive adequate ovarian steroidogenesis for
reproduction. But the potential benefit of additional exogenous LH supplementation in ART is
still controversial .
Different meta-analyses did not demonstrate any benefit of the r-hLH supplementation in
increasing clinical outcome . However, in patients of advanced age undergoing ART, likely to
include a larger proportion of poor responders, the addition of r-hLH seems to be beneficial
.
In a previous study, the investigators demonstrated that r-hLH supplementation during
ovarian stimulation, significantly reduces apoptosis in the cumulus cells, improving oocyte
competence that is necessary for adequate fertilization and the consecutive embryogenesis
that ends with implantation.
Given this background, it seems appropriate to investigate the effects of three different
ovarian stimulation protocols (HP-hMG, r-hFSH and r-hFSH/r-hLH), used as routine in the
ovarian stimulation therapy, in a pilot prospective observational study, evaluating the
effects of recombinant LH and extractive hCG (with LH like activity) on the biological
outcome as well as on the clinical outcome. The apoptosis rate of the cumulus cell, usually
discarded after oocyte collection, was used as molecular biomarker to assess the oocyte
quality, as biological outcome. The clinical outcome was estimated measuring implantation
and ongoing pregnancy rates within and between the three different ovarian stimulation
protocols
;
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