Clinical trial: Oral Versus Vaginal Progesterone for Luteal Phase Supplementation in Frozen Embryo Transfer Cycles (NCT04758871)

Eligibility criteria:
Inclusion Criteria:

          -  ≤40 years of age at the time of IVF/ICSI treatment

          -  BMI ≥18 to ≤30 kg/m2 with a documented history of infertility

          -  Have undergone COS as part of an ART treatment and have had an unsuccessful fresh
             embryo transfer in that cycle, OR, have undergone freeze all strategy

          -  Scheduled to undergo FET with a standard exogenous/programmed hormonal replacement
             therapy (HRT) regimen

          -  Have at least 1 blastocyst vitrified on the 5th or 6th day after oocyte retrieval

          -  Elective single embryo (blastocyst) transfer (SET)

          -  Normal ultrasound examination at enrollment (or if <12 months old)

          -  Signed patient authorization for use/disclosure of data.

        Exclusion Criteria:

          -  Women with a history of recurrent miscarriage, defined as >2 consecutive miscarriages
             (biochemical pregnancy losses are not included)

          -  Absence of implantation (serum hCG = negative) after two consecutive cycles of IVF,
             ICSI or FET where the cumulative number of transferred embryos was >4 cleavage-stage
             embryos and >2 blastocysts

          -  Presence of hydrosalpinx that is not surgically treated

          -  Endometrial abnormalities on scanning during ovarian stimulation, such as endometrial
             polyp(s), sub mucosal fibroid(s), endometrial hyperplasia, endometrial fluid
             accumulation, or endometrial adhesions

          -  Participating in another clinical study at the same time

          -  Known allergic reactions to dydrogesterone or other progestogens products

          -  Any contraindication or other condition that precludes use of dydrogesterone in a
             particular patient, in accordance with the precautions listed in the locally approved
             label

          -  Mental disability or any other lack of fitness, in the Investigator's opinion, to
             preclude subjects in or to complete the study

          -  History of prior chemotherapy

          -  Contraindication for pregnancy

          -  Transfer of >1 embryo
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