Clinical trial: Trigger Timing in Ovarian Stimulations (NCT04163133)

Eligibility criteria:
Inclusion Criteria:

          -  Age: ≥18 and <35 years old

          -  AFC: ≥5 and <20

          -  AMH: ≥1.1 ng/mL and <2.5 ng/mL

          -  BMI: ≥18.5 Kg/m2 and <29 Kg/m

          -  First or second ART cycle

          -  Regular menstrual cycles (between 22 and 35 days)

          -  Two ovaries present

          -  Planned for single or double day 3 transfer

          -  Infertile couples scheduled for their first IVF/ICSI cycle with fixed antagonist
             protocol.

          -  Informed consent obtained.

        Exclusion Criteria:

          -  Women with contraindication for IVF or ICSI, such as poorly controlled type 1 or type
             2 diabetes mellitus; undiagnosed liver disease or dysfunction (based on serum liver
             enzyme test results); renal disease or abnormal serum renal function; significant
             anemia; history of deep venous thrombosis, pulmonary embolus or cerebrovascular
             accident; uncontrolled hypertension or known symptomatic heart disease; history of (or
             suspected) cervical carcinoma, endometrial carcinoma or breast carcinoma; and
             undiagnosed vaginal bleeding.

          -  Previous history of poor ovarian response (<4 oocytes retrieved) with a maximal dose
             of OS (≥300 IU/day) or OHSS, regardless of gonadotropin dose

          -  Known reasons for impaired implantation (i.e. hydrosalpinx, fibroid distorting the
             endometrial cavity, Asherman's syndrome, thrombophilia or endometrial tuberculosis)

          -  Repeated miscarriages (>2 previous biochemical pregnancies or >2 spontaneous
             miscarriages)

          -  Recurrent implantation failure (>3 failed cycles with good quality embryos)

          -  PCOS

          -  Untreated thyroid disfunction

          -  Administration of exogenous E2, P4 or gonadotropins in the preceding menstrual cycle

          -  Active female smoking

          -  Ongoing pregnancy

          -  Women who have previously enrolled in the trial

          -  Those unable to comprehend the investigational nature of the proposed study

          -  either male partner or female partner has to receive donor sperm or donor eggs.

          -  Either male partner or female partner has to receive PGD and PGS.
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