Clinical trial: MENOPUR in Gonadotrophin-releasing Hormone (GnRH) Antagonist Cycles With Single Embryo Transfer (NCT00884221)

Eligibility criteria:
Inclusion criteria:

          -  Informed Consent Documents signed prior to screening evaluations

          -  In good physical and mental health

          -  Pre-menopausal females 21-34 years of age

          -  Body mass index (BMI)18-25 kg/m2

          -  Eligible for intracytoplasmic sperm injection (ICSI)

          -  Unexplained infertility or partner with mild male factor infertility

          -  Infertility for at least 12 months before randomization

          -  Regular menstrual cycles of 24-35 days, presumed to be ovulatory

          -  Hysterosalpingography, hysteroscopy, or transvaginal ultrasound documenting a uterus
             consistent with expected normal function

          -  Transvaginal ultrasound documenting expected normal function of the ovaries

          -  Early follicular phase serum levels of FSH between 1 and 12 IU/L

          -  Early follicular phase total antral follicle (diameter 2-10 mm) count ≥ 10 for both
             ovaries combined

          -  Willing to accept transfer of one blastocyst in the fresh cycle

          -  Willing to undergo frozen embryo replacement cycles with transfer of one blastocyst
             per cycle within the first year after randomisation

        Exclusion criteria:

          -  Known polycystic ovarian syndrome or known endometriosis stage I-IV

          -  Diagnosed as "poor responder" in a previous controlled ovarian stimulation (COS) cycle

          -  Severe ovarian hyperstimulation syndrome (OHSS)in a previous COS cycle

          -  History of recurrent miscarriage

          -  Current or past (12 months prior to randomization) abuse of alcohol or drugs, and/or
             current (last month) intake of more than 14 units of alcohol per week

          -  Current or past smoking habit of more than 10 cigarettes per day

          -  Hypersensitivity to any active ingredient or excipients in the medicinal products used
             in the trial

          -  Hypersensitivity to gonadotrophin-releasing hormone (GnRH) or any other GnRH analogue

          -  Previous participation in the trial

          -  Use of any non registered investigational drugs during 3 months before randomization
Female
No healthy subjects accepted to join the trial.
Subject must be at least 21 Years old.
Subject must be at most 34 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