A Phase 3b Study to Evaluate Subject Satisfaction With Follitropin Alfa Injection in Oligoanovulatory Infertile Women Undergoing Ovulation Induction
A Phase 3b Study to Evaluate Subject Satisfaction With Follitropin Alfa Injection in Oligoanovulatory Infertile Women Undergoing Ovulation Induction
This is a prospective, open-label, multicenter, trial evaluating subject satisfaction and
 efficacy with follitropin alfa injection applied by Pen device compared with the subject's
 previous experience with injectable gonadotropins in oligoanovulatory infertile women
 undergoing ovulation induction
Inclusion Criteria:

 -  Infertile woman wishing to conceive who has had at least 1 previous cycle of treatment
 with injectable gonadotropins within the past 6 months, excluding treatment with any
 gonadotropin multi-dose formulation in vials or administered by Pen device, whose
 physician has recommended that she undergo ovulation induction. This inclusion
 criterion is modified to include subjects who had previous treatment with any
 gonadotropin multi-dose formulation in vials, excluding those gonadotropins
 administered by a Pen device

 -  Premenopausal and aged 18-40 years, inclusive

 -  Ovulatory dysfunction as defined by any of the following (a) usual cycle length less
 than (<) 21 or greater than (>) 35 days with at least 6 menses per year (b) usual
 cycle length > 35 days with less than 6 menses per year. Subjects in this group must
 have a positive response to a progesterone challenge within the past 6 months or
 during the screening period

 -  Spontaneous menses or a positive response to progestin withdrawal within 6 months of
 the start of gonadotropin therapy or positive response to clomiphene citrate
 withdrawal at least 30 days prior to start of gonadotropin therapy is acceptable to
 demonstrate induced menses

 -  Normal Papanicolaou (PAP) smear within 6 months prior to initial visit

 -  Male partner with an acceptable semen analysis within 6 months prior to study entry,
 according to the standard practice at the clinic, for ovulation induction. Use of
 donor sperm is acceptable

 -  Body mass index (BMI) less than 35.0 kilogram per square meter (kg/m^2). BMI = Body
 Weight / Height x Height (BMI is equal to body weight [kilogram {kg}] divided by
 Height * Height [square meter {m^2}])

 -  Patency and apparent normality of at least 1 fallopian tube with an ipsilateral
 functional ovary, as documented by an hysterosonogram or hysterosalpingography (HSG)
 within 3 years prior to study entry

 -  Local laboratory screening results demonstrating the following, within the past year:
 (a) prolactin within normal limits (b) Follicle stimulating hormone (FSH) within the
 normal limit for the early follicular phase at the local laboratory (c) thyroid
 stimulating hormone (TSH) within normal limits. Subjects with low TSH levels who were
 receiving replacement therapy could be enrolled at the discretion of the Investigator

 -  Been willing and able to comply with the protocol for the duration of the study

 -  Voluntarily provided written informed consent and a subject authorization under Health
 Insurance Portability and Accountability Act (HIPAA), prior to any study-related
 procedure not part of normal medical care, with the understanding that consent could
 be withdrawn by the subject at any time without prejudice to their future medical
 care. The male partner must also have provided a written subject authorization under
 HIPAA

 Exclusion Criteria:

 -  Clinically significant systemic disease or clinically significant abnormal hematology,
 chemistry, or urinalysis results at screening

 -  Previous treatment with any gonadotropin multi-dose formulation in vials or
 administered by Pen device in the past 6 months

 -  Any significant allergic disease, which in the opinion of the Investigator could
 interfere with study treatment

 -  Known infection with Human Immunodeficiency Virus (HIV), Hepatitis B or C virus

 -  Prior severe Ovarian Hyperstimulation Syndrome (OHSS)

 -  Significant allergic response to gonadotropin preparations

 -  Ongoing pregnancy, any pregnancy within 3 months prior to study entry, or any
 contraindication to pregnancy or carrying pregnancy to term

 -  Clinically significant abnormal findings evident on a transvaginal pelvic ultrasound
 performed within 2 cycles (maximum 90 days) of study entry

 -  Poor response in a prior gonadotropin stimulation cycle, defined as an estradiol level
 < 100 pg/mL per mature follicle (>=16 mm mean diameter)

 -  Prior excessive response to gonadotropin stimulation as defined by development of >3
 mature follicles at a treatment dose of 75 IU FSH

 -  Treatment with gonadotropins, clomiphene citrate, insulin-sensitizing agents (e.g.,
 metformin, Avandia®) or Gonadotropin Releasing Hormone (GnRH) analogs within 1 month
 prior to study entry

 -  Hypothyroidism (untreated). Subjects with low Thyroid Stimulating Hormone (TSH) levels
 who were receiving replacement therapy (e.g., Synthroid) could be enrolled at the
 discretion of the Investigator if local laboratory results demonstrated satisfactory
 thyroid function

 -  Hyperprolactinemia (untreated)

 -  Abnormal, undiagnosed, gynecological bleeding

 -  Known current American Society Reproductive Medicine (ASRM) Stage 3 or 4 endometriosis

 -  A residual ovarian cyst with a mean diameter >25 mm or an estradiol (E2) >100 pg/mL at
 the baseline examination

 -  Three or more consecutive pregnancy losses, due to any cause

 -  Known current substance abuse (including smokers consuming more than 5 cigarettes/day)

 -  Previous participation (within 3 months prior to study entry) in another
 investigational drug or drug delivery system trial