Convenience and Safety of Assisted Reproductive Technology Procedures Using a Gonal-F Filled by Mass (Fbm) Liquid Formulation Applied by Pen for Ovulation Induction and In-vitro Fertilization
Condition: Infertility; Ovulation Induction; In-Vitro Fertilization
MeSH terms: Infertility
Intervention: GONAL-f®
Intervention description: GONAL-f® will be administered subcutaneously to subjects between Day 2 and Day 5 of their cycle with a starting dose of 75 International Units (IU) per day for subjects who undergo ovulation induction (OI)/artificial insemination (IUI) and between 150 and 225 IU per day for subjects who undergo in-vitro fertilization (IVF). For subjects who undergo OI/IUI, the dose will be increased by 37.5 IU after Day 14 up to Week 4 if no ovarian response is observed.
Intervention MeSH terms: Follicle Stimulating Hormone
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 215.0
Sex: Female
Minimum age: 18 Years
Maximum age: 43 Years
Healthy volunteers: No
Keywords: Infertility; Ovulation induction; Gonal-F; Follitropin alpha; Controlled ovarian stimulation

Summary:

      This was a prospective, open-label, non-comparative, Phase IIIb trial to assess the
      convenience, safety and efficacy of the new Gonal-F fbm [recombinant follicle stimulating
      hormone (r-FSH)] liquid formulation, in common setting for ovulation induction (OI) and also
      in in-vitro fertilization (IVF).
    

Eligibility criteria:

        Inclusion Criteria:

          -  Female subjects aged between 18 and 43 years

          -  Ambulatory subjects

          -  Subjects who are willing to get pregnant and are infertile, that justifies ovarian
             stimulation treatment for mono-/pauci-follicular development (OI or IUI) or multiple
             follicular development for IVF/Intracytoplasmic Sperm Injection (ICSI) procedures

          -  Subjects who are able to communicate well with the investigator and to comply with the
             requirements of the entire study

          -  Subjects who have given written informed consent, prior to treatment

        Exclusion Criteria:

          -  Subjects with enlarged ovaries or cysts unrelated to polycystic ovaries

          -  Subjects with extra-uterine pregnancy during the last 3 months

          -  Subjects with several endometriosis (Grade III & IV)

          -  Subjects with history of severe ovarian hyperstimulation syndrome

          -  Subjects with history of thromboembolic event

          -  Subjects with malformative uterine pathology that could disturb either implantation or
             pregnancy processes

          -  Subjects with premature menopause

          -  Subjects with gynecological bleeding of unknown origin

          -  Subjects with ovarian, uterine, or mammary cancer

          -  Subjects with tumors of the hypothalamus or the pituitary glands

          -  Subjects with history of serious allergy or atopic asthma disease

          -  Subjects with known allergic reaction against one of the Follicle Stimulating Hormone
             (FSH) and ingredients,

          -  Ongoing pregnant, or breast feeding subjects

          -  Subjects who have participated in a trial during the last 3 months