CONSORT Randomized Controlled Trial in Assisted Reproductive Technology
Condition: Infertility
MeSH terms: Infertility
Intervention: GONAL f® prefilled pen; GONAL f® prefilled pen
Intervention description: GONAL f® doses starting at minimum of 112.5 IU per day and a maximum of 450 IU per day for 1 cycle only; GONAL f® standard treatment arm (150 IU of GONAL f® per day) up to Day 5 of stimulation after which the dose can be adjusted based upon the subject's ovarian response and according to the center's standard practice.
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: 200.0
Sex: Female
Minimum age: 18 Years
Maximum age: 34 Years
Healthy volunteers: No
Keywords: Infertility; Assisted reproductive technology

Summary:

      The overall objective of this trial is to compare the ovarian response in assisted
      reproductive technology (ART) subjects administered GONAL f® according to the 'Consistency in
      recombinant follicle stimulating hormone [r-FSH] starting doses for individualized treatment'
      (CONSORT) calculator versus given a standard GONAL f® dose of 150 International Unit (IU) per
      day.
    

Eligibility criteria:

        Inclusion Criteria:

          1. Female subjects justifying an in-vitro fertilization (IVF)/embryo transfer (ET)
             treatment

          2. Have a male partner with semen analysis within the past 6 months prior to
             randomization 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

          3. Between her 18th and 35th birthday (35 not included) at the time of the randomization
             visit

          4. Body mass index (BMI) lower than 30 kilogram per square meter (kg/m^2) where the BMI
             is calculated according to the formula

          5. Have a regular spontaneous ovulatory menstrual cycle between 21 and 35 days in length

          6. Have an early follicular phase (Day 2-4) serum level of basal FSH lower than or equal
             to 12 International Unit per Liter (IU/L) measured in the center's local laboratory
             during the screening period (i.e. within 2 months prior to down-regulation start)

          7. Presence of both ovaries

          8. Normal uterine cavity, which in the investigator's opinion is compatible with
             pregnancy

          9. Have a negative cervical papanicolaou (PAP) test within the last 6 months prior to
             randomization

         10. Have at least 1 wash-out cycle (defined as greater than or equal to 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 gonadotropin
             releasing hormone (GnRH) agonist therapy

         11. Willing and able to comply with the protocol for the duration of the trial

         12. Have given written informed consent, prior to any trial-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:

          1. Have greater than or equal to 2 previous ART cycles with a poor response to
             gonadotrophin stimulation (defined as lower than or equal to 5 mature follicles and/or
             lower than or equal to 3 oocytes collected) or have greater than or equal to 2
             previous ART cycles with a hyper response (defined as greater than or equal to 25
             oocytes retrieved)

          2. Any medical condition, which in the judgment 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 Merck Serono's Medical responsible

          3. Have previous severe ovarian hyperstimulation syndrome (OHSS)

          4. Polycystic ovary syndrome (PCOS; Rotterdam criteria) to reduce the risk of the
             occurrence of OHSS

          5. Presence of endometriosis requiring treatment

          6. Uterine myoma requiring treatment

          7. Any contraindication to being pregnant and/or carrying a pregnancy to term

          8. Extra-uterine pregnancy within the last 3 months prior to screening

          9. History of 3 or more miscarriages (early or late miscarriages) due to any cause

         10. Tumors of the hypothalamus and pituitary gland

         11. Ovarian enlargement or cyst of unknown etiology

         12. Ovarian, uterine or mammary cancer

         13. A clinically significant systemic disease

         14. Known infection with Human Immunodeficiency Virus (HIV), Hepatitis B or C virus in the
             trial subject or her male partner,

         15. Abnormal gynecological bleeding of undetermined origin

         16. Known allergy or hypersensitivity to human gonadotrophin preparations,

         17. Any active substance abuse or history of drug medication or alcohol abuse in the past
             5 years prior to the screening visit

         18. Entered previously into this trial or simultaneous participation in another clinical
             trial