A Trial to Compare the Efficacy and Safety of Ovarian Stimulation With GONAL-f® and Luveris® Starting on Day 1 Versus Day 6 in Women Undergoing Assisted Reproductive Technique
Condition: Infertility; Fertility; Follicle Stimulating Hormone Deficiency
MeSH terms: Infertility
Intervention: GONAL-f®; Luveris®; Recombinant human chorionic gonadotropin (r-hCG)
Intervention description: GONAL f® 300 international units [IU] per day as subcutaneous injection using liquid pen.; Luveris® 150 IU per day lyophilized powder for subcutaneous injection.; A single injection of r-hCG (Ovidrel®/Ovitrelle®) 250 mcg to induce final oocyte maturation.
Intervention MeSH terms: Chorionic Gonadotropin
Phase: Phase 3
Study type: Interventional
Primary purpose: Supportive Care
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 174.0
Sex: Female
Minimum age: 36 Years
Maximum age: 42 Years
Healthy volunteers: No
Keywords: Reproduction Techniques; Reproductive Medicine; Assisted Reproductive Technics; Pregnancy Rate; Ovulation Induction; Ovarian Stimulation; Oocytes; Implantation

Summary:

      This is a phase IIIb, interventional, multicenter, multinational, randomised, open-label,
      comparative trial which primary objective is to generate data on the ovarian stimulation
      profile obtained when Luveris® is started either on Day 1 or Day 6 in women in advanced
      reproductive age (36-42) undergoing Assisted Reproductive Technique (ART).
    

Eligibility criteria:

        Inclusion Criteria:

          -  Should be a female subject justifying an In Vitro Fertilization/Embryo transfer
             (IVF)/ET treatment

          -  Should be between 36th and 42nd birthday (both included) at the time of the
             randomization visit

          -  Have early follicular phase (day 2-4) serum level of basal FSH <= 12 IU/L measured in
             the center's local laboratory during the screening period (i.e. within 2 months prior
             to down regulation start)

          -  Have a regular spontaneous ovulatory menstrual cycle between 21 and 35 days in length

          -  Presence of both ovaries

          -  Normal uterine cavity, which in the investigator's opinion is compatible with
             Pregnancy

          -  Have a negative cervical Papanicolaou (PAP or smear) test within the last 6 months
             prior to randomization

          -  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 GnRH agonist therapy

          -  Be willing and able to comply with the protocol for the duration of the trial

          -  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

          -  Have a male partner with semen analysis within the past 6 months prior to
             randomization considered adequate to proceed with regular insemination or
             intra-cytoplasmic sperm injection (ICSI) according to the center's standard practice

        Exclusion Criteria:

          -  Had 2 (or more) previous ART cycles with a poor response to gonadotrophin stimulation
             defined as 6 (or less) mature follicles and/or 4 (or less) oocytes collected in any
             previous IVF cycle or previous cycles with a hyper response defined as 25 (or more)
             oocytes retrieved

          -  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

          -  Had previous severe ovarian hyperstimulation syndrome (OHSS)

          -  Polycystic ovary syndrome (PCOS; Rotterdam criteria) to reduce the risk of the
             occurrence of OHSS

          -  Presence of endometriosis requiring treatment

          -  Uterine myoma requiring treatment

          -  Any contraindication to being pregnant and/or carrying a pregnancy to term

          -  Extra-uterine pregnancy within the last 3 months prior to screening

          -  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 etiology

          -  Ovarian, uterine or mammary cancer

          -  A clinically significant systemic disease

          -  Known infection with Human Immunodeficiency Virus (HIV), Hepatitis B or C virus in the
             trial subject or her male partner

          -  Abnormal gynecological 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 prior to the screening visit

          -  Entered previously into this trial or simultaneous participation in another clinical
             trial

          -  Pregnancy and lactation period

          -  Participation in another clinical trial within the past 30 days