Clinical trial: A Phase II Study to Assess the Efficacy and Safety of Luveris® (Lutropin Alfa) in Mid Follicular Phase for Controlled Ovarian Stimulation (COS) in Advanced Reproductive Age (NCT01079949)

Eligibility criteria:
Inclusion Criteria:

          -  Premenopausal woman, aged 35 to 42 years wanting to become pregnant

          -  Subjects with FSH baseline plasma levels less than or equal to 10 IU/L (Day 2-5 of the
             cycle) and with LH and E2 levels within the normal limits of the local laboratory

          -  Subjects having regular spontaneous menstrual cycle lasting 25-35 days

          -  Subjects with infertility that is susceptible to treatment with IVF/ICSI

          -  Subjects to be included in a COS protocol with r-hFSH and GnRHant

          -  Subjects with partner's sperm suitable for IVF/ICSI according to local laboratory,
             unless sperm donor is to be used

          -  Subjects with both ovaries

          -  Subjects with uterine cavity capable of sustaining the implantation of embryo or
             carrying a pregnancy

          -  Subjects with normal pap smear (papanicolaou) 6 months prior to be included in the
             study (signature of informed consent)

          -  Subjects with body mass index (BMI) less than (<) 30 at the beginning of ovarian
             stimulation

          -  Subjects with confirmed absence of pregnancy with the beta-hCG test (urine or blood)
             before starting the administration of r-hFSH

          -  Subjects willing to adjust to the protocol for the entire duration of the study

          -  Subjects who have given informed consent prior to any study-related procedure that is
             not part of normal medical care

        Exclusion Criteria:

          -  Subjects or her partner with known positivity for human immunodeficiency virus (HIV)
             or Hepatitis-B /Hepatitis-C virus (HBV/HCV)

          -  Subjects with any systemic illnesses of clinical significance, hypothalamus and
             pituitary tumors; cancer of ovaries, uterus or breast; hormonal anomalies and/or
             medical, biochemical, hematological illnesses that, according to the investigator,
             could interfere with the treatment with gonadotropins

          -  Subjects with more than 2 previous ART cycles

          -  Subjects who have cancelled two previous ART cycles

          -  Subjects with frozen embryos from previous ART cycles

          -  Subjects with non-specific gynecological bleeding

          -  Subjects with ovaries that are polycystic, increased in size or with cysts of unknown
             etiology

          -  Subjects with any contraindication for becoming pregnant and/or carrying pregnancy to
             term

          -  Subjects with known allergy to gonadotropin preparations or any of the excipients

          -  Subjects with drug dependence or history of drug or alcohol abuse in the previous 5
             years

          -  Subjects who have previously entered into this study or simultaneous participation in
             another clinical drug trial with drugs

          -  Subjects who are unwilling to or not being able to adjust to the study protocol
Female
No healthy subjects accepted to join the trial.
Subject must be at least 35 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? 0