Clinical trial: Efficacy and Safety of Crinone Versus Combination Medication (ACCESS) (NCT03858049)

Eligibility criteria:
Inclusion Criteria:

        Participants are eligible to be included in the study only if all the following criteria
        apply:

          -  Participants who will receive artificial frozen-thawed embryo transfer (FET) cycle
             study interventions

          -  Participants who have no more than two Day 5 embryos are planned to be transferred
             (follow the clinical practice of the study site)

          -  Participants have received estradiol valerate for no more than 20 days

          -  Participants have a transitional-endometrium of greater than or equal to 8 millimeter

          -  Participants have normal uterine cavity

          -  Participants can give signed informed consent

          -  Participants are willing to follow the study protocol and able to complete the study

        Exclusion Criteria:

          -  Participants are willing to follow the study protocol and able to complete the study

          -  Participants with greater than or equal to three previously failed cycles of ET

          -  Participants with diseases that cannot tolerate pregnancy

          -  Hydrosalpinx

          -  Severe endometriosis (Endometriosis American Society for Reproductive Medicine (ASRM)
             criteria from 1996)

          -  Known hypersensitivity to progesterone, the excipients of Crinone and Duphaston
             Vaginal bleeding of unknown origin

          -  History of recurrent miscarriages

          -  Vaginitis

          -  Thromboembolic diseases (thrombophlebitis, thromboembolic disorder, or cerebral
             apoplexy) or participants with a history of these conditions

          -  Known or suspected progestogen-dependent neoplasm

          -  Participation in another clinical trial within the past 30 days

          -  Contraindications of both Crinone and Duphaston
Female
No healthy subjects accepted to join the trial.
Subject must be at least 20 Years old.
Subject must be at most 38 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