Clinical trial: Effect of Different Ovarian Stimulation Protocols on Endometrial Receptivity (NCT03755973)

Eligibility criteria:
Inclusion Criteria:

          1. Informed consent form (ICF) dated and signed.

          2. Age: ≥18 and <40 years old.

          3. AFC ≥5 and <20.

          4. AMH ≥1.1 ng/mL and <2.5 ng/mL, performed in the 12 months prior to inclusion.

          5. Body Mass Index (BMI): ≥18.5 Kg/m2 and <30 Kg/m2.

          6. Weight: ≥50 kg and <80 kg.

          7. First or second ART cycle or fertility preservation cycle.

          8. Regular menstrual cycles (between 22 and 35 days).

          9. Two ovaries present.

         10. Pregnancy-wish.

         11. Planned for single blastocyst transfer.

        Exclusion Criteria:

          1. Simultaneous participation in another clinical study.

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

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

          4. Repeated miscarriages (>2 previous biochemical pregnancies or >2 spontaneous
             miscarriages).

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

          6. Polycystic ovary syndrome (PCOS).

          7. Tumours of the ovary, breast, uterus, pituitary or hypothalamus.

          8. Abnormal (not menstrual) vaginal bleeding without a known/diagnosed cause.

          9. Ovarian cysts or enlarged ovaries.

         10. Fibroid tumours of the uterus incompatible with pregnancy.

         11. Malformations of the reproductive organs incompatible with pregnancy.

         12. Primary gonadal failure.

         13. Renal impairment defined as estimated glomerular filtration rate of 90 ml/min/1.73 m2
             determined by the Modified Diet and Renal Disease (MDRD) equation at screening.

         14. Previous antibiotic hypersensitivity reactions (streptomycin and/or neomycin).

         15. Risk factors for thromboembolic events, such as a personal or family history, severe
             obesity or thrombophilia.

         16. Moderate or severe hepatic impairment.

         17. Untreated and uncontrolled thyroid dysfunction.

         18. Current use of oral contraceptive, anti-depressants, anti-psychotics, steroids,
             anti-epileptics or chemotherapy.

         19. Administration of exogenous Estradiol (E2), Progesterone (P4) or gonadotropins in the
             preceding menstrual cycle.

         20. Active female smoking.

         21. Acceptors of donated oocytes/embryos.

         22. Ongoing pregnancy.

         23. Women who have previously enrolled in the trial.

         24. Those unable to comprehend the investigational nature of the proposed study.
Female
No healthy subjects accepted to join the trial.
Subject must be at least 18 Years old.
Subject must be at most 39 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