Safety and Efficacy of Pre-defined, Fixed Dose of Gonal-f Pen Based on Subject Baseline Characteristics in Subjects Undergoing in Vitro Fertilization (IVF)
Condition: Infertility
MeSH terms: Infertility
Intervention: Gonal-f; Recombinant human chorionic gonadotrophin (r-hCG)
Intervention description: GONAL-f (follitropin alfa) will be administered subcutaneously based on ART treatment guidelines, which determined the optimal dose of r-hFSH based on subject baseline characteristics/predictors of ovarian response throughout stimulation cycle.; When at least 1 follicle greater than or equal to (>=) 18 millimeter (mm) and 2 follicles >=16 mm in diameter develop, 250 microgram (mcg) of recombinant human chorionic gonadotrophin (r-hCG) will be administered.
Intervention MeSH terms: Chorionic Gonadotropin; Follicle Stimulating Hormone
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 166.0
Sex: Female
Minimum age: 18 Years
Maximum age: 34 Years
Healthy volunteers: No
Keywords: Assisted Reproductive Technology (ART); Infertility; Ovarian stimulation

Summary:

      Clinical validation of the assisted reproductive technology (ART) treatment guidelines, which
      determine the optimal dose of recombinant human follicle stimulating hormone (r-hFSH) based
      on subject baseline characteristics/predictors of ovarian response.
    

Eligibility criteria:

        Inclusion Criteria

          -  Be an infertile subject justifying an in-vitro fertilization/embryo transfer (IVF/ET)
             treatment.

          -  Have a male partner with semen analysis within the past six months prior to study
             entry considered adequate to proceed with regular insemination or intracytoplasmic
             sperm injection (ICSI) according to the center's standard practice. If these criteria
             are not met, the subject can only be entered if donor sperm will be used.

          -  Be between her 18th and 35th birthday (35 not included).

          -  Have a regular spontaneous ovulatory menstrual cycle between 21 and 35 days in length.

          -  Have early follicular phase (Day 2-4) serum levels within the last 3 months prior to
             study entry of:

          -  Follicle stimulating hormone (FSH) greater than or equal to (>=) 12 International
             units per liter (IU/L), and

          -  Oestradiol (E2) within center's local normal laboratory range values.

          -  Presence of both ovaries.

          -  Have a uterine cavity without abnormalities, which, in the investigator's opinion,
             could impair embryo implantation or pregnancy evolution as assessed within the last 3
             years using ultrasound (US), hysteroscopy (HSC), or hysterosalpingography (HSG).

          -  Have a negative cervical papanicolaou (PAP) test within the last 6 months prior to
             study entry.

          -  Have at least one wash-out cycle (defined as >= 30 days since the last dose of
             clomiphene citrate or gonadotrophin treatment) since the last ART cycle and/or
             clomiphene citrate or gonadotrophin treatment prior to starting gonadotrophin
             releasing hormone (GnRH) agonist therapy.

          -  Have a negative pregnancy test prior to beginning GnRH agonist therapy.

          -  Be willing and able to comply with the protocol for the duration of the study. Have
             given written informed consent, prior to any study-related procedure not part of
             normal medical care, with the understanding that consent may be withdrawn by the
             subject at any time without prejudice to her future medical care.

        Exclusion Criteria:

          -  Had 2 previous ART cycles with a poor response to gonadotrophin stimulation, defined
             as less than or equal to (<=) 5 mature follicles and/or <=3 oocytes collected in any
             previous IVF cycle or hyper response, defined as >=25 oocytes retrieved.

          -  Any medical condition, which in the judgement of the investigator may interfere with
             the absorption, distribution, metabolism or excretion of the drug. In case of doubt,
             the subject in question should be discussed with Serono's Therapeutic Director.

          -  Had previous severe ovarian hyperstimulation syndrome (OHSS).

          -  A body mass index (BMI) greater than (>) 30 kilogram per square meter (kg/m^2)

          -  Any contraindication to being pregnant and/or carrying a pregnancy to term.

          -  Extra-uterine pregnancy within the last 3 months.

          -  History of 3 or more miscarriages (early or late miscarriages) due to any cause.

          -  Tumours of the hypothalamus and pituitary gland.

          -  Ovarian enlargement or cyst of unknown aetiology.

          -  Ovarian, uterine or mammary cancer.

          -  A clinically significant systemic disease.

          -  Known infection with Human Immunodeficiency Virus (HIV), Hepatitis B or C virus.

          -  Abnormal gynaecological bleeding of undetermined origin.

          -  Known allergy or hypersensitivity to human gonadotrophin preparations.

          -  Any active substance abuse or history of drug, medication or alcohol abuse in the past
             5 years.

          -  Entered previously into this study or simultaneous participation in another clinical
             trial