Clinical trial: Study to Evaluate if the Addition of r-hLH (Luveris®) to FSH From Day 8 of Ovarian Stimulation is Able to Decrease Total FSH Dose and to Improve Cycle Outcome in Infertile Women Undergoing ART, Who Required High FSH Dose in a Previous Cycle (NCT01071200)

Eligibility criteria:
Inclusion Criteria:

          -  Pre-menopausal infertile woman, aged 18 to 40 years inclusive, who wishes to conceive

          -  Regular, spontaneous menstrual cycle of 25-35 days

          -  Body mass index (BMI) ≤ 28

          -  FSH ≤ 10 IU/L (follicular phase, days 2-5)

          -  Prolactin (PRL) within the normal ranges

          -  Evidence of both ovaries by ultrasound scan

          -  Women undergoing IVF-Embryo Transfer (ET) or ICSI, down regulated with Gonadotropin
             releasing hormone analogues (GnRHa) (daily dose) under controlled ovarian
             hyperstimulation (COH) with FSH

          -  Washout > 90 days from last dose of clomiphene or gonadotrophin, before ongoing COH
             cycle

          -  Only one previous IVF-ET or ICSI cycle (in the last 9 months preceding the ongoing COH
             cycle) resulted in a hypo-response properly documented (from 6 to 12 oocytes with a
             total FSH dose ≥ 4000 IU)

          -  Negative pregnancy hCG test (urine or blood sample) before the ongoing COH cycles

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

          -  Written informed consent before applying any procedure related to the study protocol,
             which is not part of routine medical care, with the understanding that consent may be
             withdrawn by the subject at any time, without prejudice on their future medical care

        Exclusion Criteria:

          -  Oligo/Anovulatory cycles (World Health Organization [WHO] I and II)

          -  Male partner azoospermia (assessed within the last 12 months)

          -  Follicular phase (day 2-5) FSH > 10 IU/L even if only once observed in the medical
             history

          -  Abnormal cervical cytology (assessed within the last 12 months)

          -  History of unexplained gynecologic hemorrhage

          -  Any contraindication to pregnancy

          -  Known allergy to gonadotrophin

          -  Any clinically important systemic disease (e.g. insulin-dependent diabetes mellitus,
             epilepsy, serious migraine, intermittent purpura, hepatic, renal or cardiovascular
             disease, serious corticoid-dependent asthma) which constitutes a contraindication to
             gonadotropin use

          -  Any medical condition which, according to the investigator's judgement, may affect the
             absorption, distribution, metabolism or excretion of the drug. In case of doubt,
             inclusion of the subject in question should be discussed with the Medical Responsible
             of Serono

          -  Known Human Immunodeficiency Virus (HIV) positivity

          -  Any substance abuse or history of drugs or alcohol abuse within the past 5 years

          -  Prior inclusion in the present study or simultaneous inclusion in a clinical study of
             another drug

          -  Refusal or inability to comply with the protocol
Female
No healthy subjects accepted to join the trial.
Subject must be at least 18 Years old.
Subject must be at most 40 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