Clinical trial: EXpression PRofile Endometrium Samples Study (NCT01210144)

Eligibility criteria:
Inclusion Criteria:

          -  Infertile female or infertile male. Infertile female means diverse infertility
             etiologies including tubal disease (excepting hydrosalpinx) and so called "unexplained
             infertility"

          -  Suitable for ART: IVF undergoing first or second attempt, ICSI undergoing first
             attempt

          -  18-35 years old, body mass index (BMI) less than or equal to 27 kilogram per square
             meter (kg/m^2), non smoking

          -  Normal ovarian status (FSH less than or equal to 9.45 International Units per Liter
             [IU/L], E2 less than or equal to 40 picogram per milliliter [pg/mL], Anti-Mullerian
             Hormone [AMH] greater than or equal to 18 picomole/liter [pmol/L]; within normal
             laboratory range values, normal ovaries sonography and uterine echo doppler)

          -  No history of active genito-urinary infection

          -  Normal thyroid function (or adequate substitution for at least 3 months)

          -  Negative cervical papanicolaou test within the last 12 months prior to study entry

          -  No hormonal therapy, including gonadotropins and progesterone, for at least 2 months
             prior to the study

          -  In couple with female infertility, male partner with normal sperm or moderate
             oligoasthenospermia in semen analysis and negative semen culture less than 6 months at
             the study entry

          -  Willingness and ability to comply with the protocol for the duration of the study

          -  Written informed consent prior to any study 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             medical care, with the understanding that consent may be withdrawn by the subject at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 their future medical care

        Exclusion Criteria:

          -  Subjects with ongoing pregnancy, any pregnancy within 3 months prior to study entry,
             or any contraindication to pregnancy or carrying pregnancy to term

          -  Subjects with uterine malformation, diethylstilbestrol syndrome, adenomyosis, synechia

          -  Subjects with history of previous OHSS

          -  Subjects with polycystic ovarian syndrome (PCOS) according to the revised Rotterdam
             Consensus 2003

          -  Subjects with extra-uterine pregnancy during the previous 3 months

          -  Subjects with recurrent miscarriages (early or late, more than 2)

          -  Subjects having known infection with human immunodeficiency virus (HIV), hepatitis B
             or C virus, for subject or partner

          -  Subjects with abnormal gynecological bleeding of undetermined origin

          -  Subjects with history of major thromboembolic disease

          -  Subjects with endometriosis

          -  Subjects with presence or history of malignant tumors and related treatment

          -  Subjects with clinically significant systemic disease or clinically significant
             abnormal hematology, chemistry, or urinalysis results at screening

          -  Subjects with known allergy or hypersensitivity to Gonal-f® or Ovitrelle®

          -  Subjects with any active substance abuse or history of drug, medication or alcohol
             abuse in the past 5 years

          -  Subjects who have participated within 3 months prior to study entry in another
             clinical trial
Female
No healthy subjects accepted to join the trial.
Subject must be at least 18 Years old.
Subject must be at most 35 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