IVF Clinical Trial
Official title:
Clomiphene Citrate Plus Gonadotropins and GnRH Antagonist Versus Flexible GnRH Antagonist Protocol Versus Microdose GnRH Agonist Protocol in Poor Responders Undergoing IVF: a Randomized Study
Poor ovarian response to stimulation in IVF cycles is a challenging and frustrating
condition, due to its poor prognosis in terms of chances of pregnancy and live births.
Various ovarian stimulation regimens have been tried to overcome these obstacles. A simple
approach is increase the dose of the gonadotropin administration, but the results in terms
of pregnancy rate are very low Another commonly used stimulation regimen is the microdose
GnRH agonist protocol, which takes advantage of the initial rise in endogenous gonadotropins
that follows the agonist administration in the early follicular phase and subsequently
prevents a premature LH surge, with fewer cycle cancellations. However, their application in
poor responders, even if in small doses and for a limited period, has been questioned as
they may cause oversuppression of ovarian function, leading to a prolonged cycle and
increased treatment costs without improving the outcomes.
Recently, GnRH antagonists were introduced in ART treatment. They are effective in
preventing a premature LH surge and allow for a more natural recruitment of follicles in the
follicular phase in a non-suppressed ovary, offering a potential alternative in the
treatment of these patients. However, randomized studies evaluating the efficacy of this
regimen in poor responders did not show any improvements in pregnancy rates. Current
approach have included the addition of oral agents such us clomiphene citrate (CC) to
gonadotropins. Some authors have investigated the role of CC in addition to low dose of
gonadotropins in mild stimulation regimen, demonstrating that, despite a small number of
retrieved oocytes, good quality embryos were produced with a subsequent improvement in the
fertilization rate, clinical pregnancy rate and live birth rate. The only study that
evaluate the efficacy of CC in addition to high doses of gonadotropins in poor responders
showed improving in number of retrieved oocytes, transferred embryos and biochemical
pregnancy; however, clinical pregnancy rate and live birth rate remained low and showed no
measurable increase.
The aim of this study was to compare the efficacy of the CC as an adjunctive to a high dose
of gonadotropins in cycles with antagonist protocols with the microdose GnRH agonist and
flexible antagonist protocols in women who responded poorly to ovarian stimulation, to
determine whether this protocol may improve IVF outcomes, offering a valid alternative in
poor responder patients treatment.
n/a
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Treatment
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