Low-dose Gonal-f® in Ovulation Induction
Condition: Infertility; Monofollicular Development
MeSH terms: Infertility
Intervention: Gonal-f®
Intervention MeSH terms: Follicle Stimulating Hormone
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 24.0
Sex: Female
Minimum age: 18 Years
Maximum age: 37 Years
Healthy volunteers: No
Keywords: Monofollicular Development; Gonal-f®; Recombinant Follicle Stimulating Hormone; Ovarian hyperstimulation syndrome (OHSS)

Summary:

      This is a prospective, multicenter, open-label, comparative and parallel-group study of
      ovulation induction evaluating tailoring of Recombinant follicle stimulating hormone (FSH)
      treatment using the Gonal-f® prefilled pen in World Health Organization (WHO) Type 2
      anovulatory subjects who have previously failed to conceive with clomifene treatment.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Subjects eligible for ovulation induction treatment, where monofollicular development
             is the desired treatment outcome and the dose schedule outlined in the protocol is
             deemed appropriate

          -  Premenopausal female subjects, aged between 18 and 37 years inclusive

          -  Subjects desirous of pregnancy/willing to conceive

          -  Subjects who are infertile due to chronic anovulation demonstrated by cycle duration
             of greater than 35 days.

          -  Subjects who have been treated with clomifene citrate therapy, according to standard
             site practice, and have failed to ovulate and/or conceive

          -  Subjects with follicle stimulating hormone (FSH) and prolactin (PRL) serum values
             within the normal range in the early follicular phase

          -  Subjects with an overall total antral follicle count greater than 10 (of follicle size
             greater than or equal to 2 millimeter [mm] and less than 11 mm) (that is, total
             between both ovaries)

          -  Subjects with at least one patent tube, as documented by recent (within 2 years before
             treatment assignment) hysterosalpingography (HSG) or hysterosalpingo contrast
             sonography (HyCoSy)

          -  Subjects with normal uterine cavity, as documented by recent (within 2 years before
             treatment assignment) hysteroscopy, HSG or ultrasound scan

          -  Subjects with body mass index (BMI) greater than 20 and less than or equal to 32
             kilogram per square meter (kg/m^2) (BMI is equal to body weight [kilogram {kg}]
             divided by Height * Height [square meter {m^2}])

          -  Subjects with negative cervical Papanicolaou (PAP) test conducted according to
             national guidelines and/or standard site practice

          -  Male partners of female subjects with sperm compatible with non-assisted fertilization
             or availability of donor sperm, as confirmed by the Investigator

          -  Subjects who are willing and able to comply with protocol requirements and have
             provided written, informed consent

        Exclusion Criteria:

          -  Subjects with history of hypersensitivity to the investigational medicinal product
             (IMP) (active substance follitropin alpha, FSH, or to any of the excipients of
             Gonal-f®) or any other drug used in the trial (that is, Ovitrelle)

          -  Subjects with ovarian enlargement or ovarian cyst unrelated to Polycystic Ovary
             Syndrome (PCOS), and of unknown origin on ultrasound

          -  Subjects with evidence of diminished ovarian reserve (cycle length less than 26 days;
             FSH above the upper limit of local serum FSH values, total antral follicle count [AFC]
             in both ovaries less than 10)

          -  Subjects with uterine pathology/abnormalities, which in the opinion of the
             Investigator could impair pregnancy evolution

          -  Subjects who have undergone three or more previous miscarriages

          -  Subjects with any previous extrauterine pregnancy

          -  Pregnant or lactating female subjects

          -  Subjects with abnormal gynecological bleeding of unknown etiology.

          -  Subjects with previous history of severe ovarian hyper stimulation syndrome (OHSS)
             (after clomifene treatment)

          -  Subjects who have evidence of current or previous pelvic inflammatory disease before
             treatment assignment

          -  Subjects with tumors of the hypothalamus and pituitary gland

          -  Subjects with ovarian, uterine or mammary carcinoma

          -  Subjects treated with clomifene citrate or gonadotropins within 1 month of the
             screening evaluation

          -  Subjects with any medical condition which, in the opinion of the Investigator, would
             prevent an effective response, such as primary ovarian failure, or malformations of
             the reproductive organs incompatible with pregnancy

          -  Subjects with any medical condition which, in the opinion of the Investigator, may
             interfere with the absorption, distribution, metabolism or excretion of the drug

          -  Subjects with any clinically significant systemic disease (for example,
             insulin-dependent diabetes) or any contraindication to being pregnant and/or carrying
             a pregnancy to term

          -  An active substance abuser

          -  Known infection with human immunodeficiency virus (HIV), Hepatitis B or C virus in the
             trial subject or her male partner

          -  Subjects who are currently participating in another clinical trial

          -  Subjects who are unable to give written informed consent