Clinical trial: 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 (NCT01497197)

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             normal medical care, with the understanding that consent may be withdrawn by the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
Female
No healthy subjects accepted to join the trial.
Subject must be at least 36 Years old.
Subject must be at most 42 Years

Patient description (medical language): A 32-year-old woman comes to the hospital with vaginal spotting.  Her last menstrual period was 10 weeks ago. She has regular menses lasting for 6 days and repeating every 29 days. Medical history is significant for appendectomy and several complicated UTIs. She has multiple male partners, and she is inconsistent with using barrier contraceptives. Vital signs are normal.  Serum β-hCG level is 1800 mIU/mL, and a repeat level after 2 days shows an abnormal rise to 2100 mIU/mL.  Pelvic ultrasound reveals a thin endometrium with no gestational sac in the uterus.

Patient description (patient's own words): I just turned 32 and last morning I woke up with strange blood stains on my underwear. My last periods were more than 2 months ago, which is unusual for me because I used to have regular periods lasting for 6 days every 29 days, more or less. I had several UTIs in the past. I also had appendicitis. I'm currently seeing several men and, to be honest, some of them do struggle to wear a condom. I went to the hospital to check myself up and they told me that my vitals were normal. I also had a blood test on Monday, and my β-hCG level was 1800 mIU/mL, and then on Wednesday, it went up to 2100 mIU/mL. The gynecologist also did an ultrasound and she told me that, hopefully, there was no ovule.

Does the patient match the trial criteria? Contradiction