Effect of Treatment With Corifollitropin Alpha in Vitro Fertilization in Patients With Poor Ovarian Response.
Condition: Infertility
MeSH terms: Infertility
Study type: Interventional
Phase: Phase 3

Summary: 
      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
    

Detailed description: 
      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.
    

Intervention name(s): Ganirelix 0.25 mg.; Recombinant choriogonadotropin alfa; Micronized natural progesterone.
Intervention type(s): Drug; Drug; Drug
Intervention description(s): Ganirelix 0.25 mg. Route of administration: Subcutaneous use. Dose: 250μg/24h since the day observe a follicle> 14mm.; Recombinant choriogonadotropin alfa. Route of administration: Subcutaneous use. Dose: 6,500 IU, pods, when follicles> 17 mm are observed; Micronized natural progesterone. Route of administration: vaginal . Dose: 400mg/24, from embryo transfer until the day of b-hCG.
Other intervention name(s): ORGALUTRAN®.; OVITRELLE®.; PROGEFFIK®.
Intervention MeSH terms: Chorionic Gonadotropin; Progesterone; Ganirelix
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Infertility; IVF; Corifollitropin Alfa treatment; Ovarian stimulation