Ovarian Hyperstimulation Syndrome Clinical Trial
Official title:
An Uncontrolled, Open-label Feasibility Study to Demonstrate That a GnRH Agonist (Decapeptyl) Can be Safely Administered to Trigger Final Oocyte Maturation in High Responder Patients to Mitigate the Risk of OHSS
Ovarian hyperstimulation syndrome (OHSS) is a major complication of ovarian stimulation for IVF if hCG is used to trigger final oocyte maturation. The investigators propose that using GnRH agonist as a trigger will eliminate OHSS, even in high-risk patients.
Administration of hCG (10.000 or 5.000 IU) is essential in IVF protocols to trigger final
oocyte maturation after ovarian stimulation. In high responder patients with potential risk
of developing OHSS, hCG is usually withheld and the treatment cycle is cancelled without
obtaining (cryopreserved) embryos for replacement.
An alternative approach to trigger final oocyte maturation is to administer a GnRH agonist
instead of hCG. This method is not possible following a long GnRH agonist protocol which
causes down-regulation of the GnRH receptor. However, following GnRH antagonist treatment
the GnRH receptor remains receptive to competitive binding by a GnRH agonist.
It has been well-described in earlier IVF trials that a bolus of GnRH agonist will displace
the GnRH antagonist from the GnRH receptors in the pituitary inducing an endogenous LH (and
FSH) surge resulting in the maturation of oocytes and good quality embryos. In addition, the
risk of moderate-to-severe ovarian hyperstimulation syndrome (OHSS) becomes minimal due to
the rapid demise of the corpora lutea. Following luteolysis, fresh embryo transfer would
require alternative luteal phase support to secure good clinical outcome. Alternatively,
good quality embryos obtained after GnRH agonist triggering can be cryopreserved and
replaced in following frozen-thawn embryo transfer (FTET) cycles. Thus, also eliminating
late onset OHSS due to pregnancy.
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Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Prevention
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