Infertility Clinical Trial
Official title:
Prospective Randomized Study for the Evaluation of Controlled Ovarian Stimulation With Corifollitropin Alpha in Patients With Expected or Poor Ovarian Response in IVF Cycles
Patients who have had or are expected to have a poor ovarian response (POR), because they
meet any of the criteria of Bologna, can benefit from ovarian stimulation with 150 mg of
alpha Corifollitropin (CFA) (Elonva ®) as single dose for a week, in the cycles of in vitro
fertilization (IVF).
In this study aims to demonstrate non-inferiority of the Corifollitropin Alpha (CFA ) versus
daily administration of Human Menopausal Gonadotropin (hMG) (Menopur ®) during the first
seven days of ovarian stimulation, in a protocol with gonadotropin-releasing hormone ( GnRH)
antagonists
One of the most significant problems in fertilization treatments is Controlled Ovarian
Stimulation low responsiveness . The incidence of low ovarian response is estimated at
around 10-25%.The wide range of prevalence reported in the literature can be explained by
the lack of consensus existed as to the criteria for the low response.
The ovarian response to gonadotropin stimulation is crucial for successful assisted
reproduction techniques .Cycles with low rates response was obtained and increased
cancellation rate and worst pregnancy rates .
Different criteria for the definition of low response, different tests to assess ovarian
reserve and different threshold values for each has been used.
In 2010 a group of experts from the ESHRE ,achieved consensus on the criteria for low
ovarian response to homogenize the study groups and reach meaningful conclusions, are known
as "The Bologna criteria" ,they defined the "Poor Ovarian Response" (POR).
There is not sufficient to recommend most of the proposed treatments to improve pregnancy
rates in poor responders evidence.
Taking into account the profile of equivalence and safety of CFA (Corifollitropin Alpha ,
active of ELONVA ® ) , different studies had been concluded that CFA can be an alternative
to daily injections of recombinant follicle stimulating hormone ( rFSH) in normal responders
patients in vitro fertilization cycle with ovarian stimulation.But more research is needed
to determine whether long-acting recombinant follicle stimulating hormone ( rFSH) is safe
and effective for use in women with low and high response.
The ovarian controlled stimulation with Alpha Corifollitropin produces significantly more
oocytes compared to recombinant follicle stimulating hormone (r FSH ) administrated daily in
normal responders patients, For this reason , the use of Alpha Corifollitropin may be
beneficial in patients with poor response which the number of oocytes retrieved is crucial
for successful treatment
There have been two studies in which the results are compared after ovarian stimulation with
daily rFSH vs CFA . In both shows , retrospectively and prospectively , the CFA seems to be
at least as effective as hMG recombinant follicle stimulating hormone ( rFSH) daily.
There are scientific publications showing that the association of luteinizing hormone ( LH)
to recombinant follicle stimulating hormone ( rFSH) can improve embryos quality and achieved
better pregnancy rate . The pregnancy rate was not statistically significant , in normal
responders patients.
Recently reported the beneficial effect in POR patients treated with CFA and hMG.
The IVF treatment is known to affects the physical and mental condition in patients with
infertility , being the excess emotional stress one of the most important reasons for
discontinuation of treatment.
The ovarian stimulation with CFA simplifies treatment , reducing the administration of
multiple daily injections ,and may reduce the emotional burden on patients.
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