Corifollitropin Alpha and Ovarian Response
Condition: Infertility, Female
MeSH terms: Infertility; Infertility, Female
Study type: Interventional

Summary: 
      Objective: To study whether an administration of corifollitropin alpha modifies the
      follicular cohort, measured by Follicular Output Rate (FORT), compared to human menopausal
      gonadotropin (HMG), in infertile patients undergoing in vitro fertilisation (IVF).

      M/M: 306 infertile patients undergoing in vitro fertilisation (IVF). Ovarian stimulation
      protocol will be performed with a single dose of 100 μg (<60kg) or 150 μg (≥60kg)
      corifollitropin alpha in group 1 (n=147), and 150-300 IU/day human menopausal gonadotropin
      (HMG) according to age, antimullerian hormone (AMH) level and antral follicle count (AFC) in
      group 2 (n=150).

      Moreover, FORT will be calculated as the ratio of pre-ovulatory follicle (16-22 mm in
      diameter) count on day of HCG×100/small antral follicle (3-8 mm) count at baseline.
    

Detailed description: 
      Patients will be allocated for convenience into two groups: those who would receive
      corifollitropin alpha (Group 1) or HMG (Group 2).

      Ovarian stimulation protocol will be performed with a single dose of 100 μg (<60 kg) or 150
      μg (≥60 kg) of corifollitropin alpha (Elonva, Schering-Plough, Brazil) in group 1, which
      could be followed by daily administration of HMG beginning on day 8 if necessary; in group 2
      150-300 IU/day HMG (menotropin, Menopur, Ferring, Brazil) will be administered, starting on
      cycle day 3, according to age, AMH level and AFC, plus gonadotropin-releasing hormone
      antagonist co-treatment (Ganirelix 25 mcg/day, Orgalutran, Schering-Plough, Brazil) in a
      flexible protocol (at least 1 follicle >14 mm or 3 or more follicles >12 mm). Doses will be
      adjusted as needed by the patient according to the ultrasound, which is performed with a 6
      MHz multifrequency transvaginal probe (Toshiba, Japan). The criterion for HCG administration
      (5.000 IU Choriomon, Biopharma, Brazil) will be at least three follicles greater than 17 mm,
      and then, 36 hours later, transvaginal oocyte retrieval was performed. After 3 or 5 days, one
      or two good-quality embryos will be transferred. It will be performed intracytoplasmic sperm
      injection (ICSI) instead of conventional IVF when major male factor is presented.

      Primary outcome measure is FORT. Secondary outcome measures include number of oocytes
      retrieved, MII, duration of stimulation, number of embryos, embryo quality and clinical
      pregnancy rate. Adverse events, such as ovarian hyperstimulation syndrome (OHSS) or
      drug-related complications are also monitored.
    

Intervention name(s): Corifollitropin Alfa; Menotropins
Intervention type(s): Drug; Drug
Intervention description(s): Primary outcome measure is ovarian response measured by FORT. Drugs are administrated for controlled ovarian stimulation prior in vitro fertilization.; Primary outcome measure is ovarian response measured by FORT. Drugs are administrated for controlled ovarian stimulation prior in vitro fertilization.
Other intervention name(s): Elonva® (Schering-Plough); Menopur® (Ferring)
Intervention MeSH terms: Menotropins
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment