A Study to Evaluate the Baseline Follicle Stimulating Hormone, Ovarian Volume and Antral Follicle Count as Prognostic Factors of the Outcome of In-vitro Fertilisation/Intracytosolic Sperm Injection in Infertile Patients Receiving Gonal f for Controlled Ovarian Hyperstimulation
Condition: Infertility
MeSH terms: Infertility
Study type: Observational

Summary: 
      This is a phase IV non-interventional, multicentric observational study to evaluate the
      baseline follicle stimulating hormone (FSH) levels, ovarian volume, antral follicle count
      (AFC) and age as prognostic factors of the outcome of the in-vitro
      fertilisation/intracytosolic sperm injection (IVF/ICSI) in infertile subjects receiving
      Gonal-f for controlled ovarian hyperstimulation (COH).
    

Detailed description: 
      Treatment of subfertility and infertility by assisted reproduction technologies (ART) such as
      IVF and embryo transfer (ET) requires multiple follicular development to increase the number
      of female gametes, and the chances of a successful treatment outcome. These technologies
      include the stimulation of multiple follicular development by exogenous FSH administration
      and the suppression of endogenous luteinizing hormone (LH) secretion by administration of a
      GnRH analogue (antagonist or agonist, as required). A single dose of human chorionic
      gonadotropin (hCG) is administered to mimic the endogenous LH surge and induce final oocyte
      maturation after adequate follicular development. Recombinant-hFSH (r-hFSH) has been shown to
      be efficacious in terms of number of oocytes recovered and in terms of pregnancy rates as
      compared to urinary-hFSH.

      Gonal-f fill-by-mass is available as a liquid formulation that can be administered with the
      pen device. The pen device is prefilled and hence the subject does not require to assemble
      the device making it simpler to use. The prefilled pen allows the accurate delivery of a
      precise dose of r-hFSH in 37.5 International Units (IU) increments.

      OBJECTIVES

      Primary objective:

        -  Evaluation of the significance of baseline FSH, ovarian volume and AFC with a model
           adjusted for age as prognostic factors of the IVF/ICSI treatment outcome.

      This study planned to enrol 500 female subjects undergoing COH for IVF/ICSI-treatment with
      Gonal-f. Gonal-f will be administered daily subcutaneously (s.c.) according to the centre's
      usual clinical practice, commencing on Days 2 or 3 of the cycle during the stimulation
      period. Treatment with Gonal-f will be continued until adequate follicular development has
      been achieved with the dose adjusted according to the subject's response, to usually not
      higher than 450 IU daily. A single injection of 250 micrograms r-hCG or 5,000 IU up to 10,000
      IU hCG would be administered 24-48 hours after the last Gonal-f injection to induce final
      follicular maturation. Gonal-f will be started approximately 2 weeks after the start of an
      gonadotrophin-releasing hormone (GnRH) agonist treatment, both being continued until adequate
      follicular development will be achieved. Oocyte retrieval will be done 34-36 hours after hCG
      administration followed by IVF/ICSI treatment according to clinic's protocol. Each enrolled
      subject would be followed up until the confirmation of her pregnancy status. Active follow up
      of all pregnancies will be performed, including those subjects withdrawn from the study.
    

Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Subjects undergoing COH for IVF/ICSI-treatment with Gonal-f in Greece.
      
Biospecimen description: 
      Plasma, serum, urine
    
Keywords: Ovulation induction; Intrauterine insemination; Gonal-f; Controlled ovarian stimulation; Female infertility