Clinical trial: Prolutex in Frozen Embryo Transfer Cycles at the Blastocyst Stage (PROGEX) (NCT03701490)

Eligibility criteria:
Inclusion Criteria:

          -  Women attending the clinics to undergo a frozen blastocyst embryo transfer, having
             given written informed consent, with the following characteristics:

          -  18-49 years of age for subjects undergoing ET with donated oocytes (both inclusive);

          -  18-37 years of age for subjects undergoing ET with autologous oocytes (both
             inclusive);

          -  BMI <32 kg/m2;

          -  Adequate endometrium preparation (Endometrial thickness > 7 mm) and E2 levels ( >100
             pg/ml) on the day progesterone treatment is started;

          -  P4 levels <1.5 ng/ml on the day progesterone treatment is started;

          -  Transfer of 1 or 2 frozen embryos at blastocyst stage

          -  Transfer of frozen embryos of quality A and/or B according to Gardner criteria1;

          -  Semen from ejaculation either from the partner or from a bank

          -  ≤ 3 previous ET (frozen and fresh) with no pregnancy

          -  Normal uterine cavity (i.e. no polyp or protruding sub-mucosal fibroid).

        Exclusion Criteria:

          -  Presence of functional follicles > 10 mm of diameter on the day progesterone treatment
             is started;

          -  Intramural uterine fibroids that distort the uterine cavity or polyps >1 cm;

          -  Stage III or IV endometriosis (endometriomas);

          -  Hydrosalpinx;

          -  Pregnancy or lactation

          -  Malformations of the sexual organs incompatible with pregnancy;

          -  Patients affected by pathologies associated with any contraindication of being
             pregnant;

          -  Known allergy to progesterone preparations or their excipients;

          -  Uncontrolled adrenal or thyroid dysfunction;

          -  Undiagnosed vaginal haemorrhage;

          -  History of, or current arterial disease;

          -  Patients with hepatic impairment;

          -  HIV, Hepatitis B Virus or Hepatitis C Virus seropositive;

          -  Neoplasias (current) or history of neoplasia that may be responsive to progesterone;

          -  High grade cervical dysplasia;

          -  Active thrombophlebitis or thromboembolic disorders, or a history of
             hormone-associated thrombophlebitis or thromboembolic disorders;

          -  Currently dependent on alcohol, drugs or psychotropic drugs

          -  History of recurrent pregnancy loss defined as 3 or more spontaneous miscarriages
             wherein pregnancy developed to a minimum of a gestational sac on transvaginal
             ultrasonography;

          -  Participation in a concurrent clinical trial or another trial within the past 2
             months;

          -  Use of concomitant medications that might interfere with the study evaluation:
             hormonal treatments other than those used in the study, except thyroid hormones.
Female
No healthy subjects accepted to join the trial.
Subject must be at least 18 Years old.
Subject must be at most 49 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