Clinical trial: Assessing the Endometrial Environment in Recurrent Pregnancy Loss and Unexplained Infertility (NCT03401918)

Eligibility criteria:
Inclusion/Exclusion Criteria:

          1. Recurrent Pregnancy Loss

             Inclusion:

               -  Age 18-45

               -  3 or more SABs including biochemical pregnancies OR 2 or more SABs if one is
                  documented to be euploid

             Exclusion:

               -  irregular menstrual cycles

               -  Submucosal fibroid >3cm

               -  Stage 3-4 endometriosis

               -  BMI >40

               -  IUD within the last 3 months

          2. Unexplained infertility Patients

             Inclusion:

               -  TTC x >= 1 year

               -  At least one SA with TMS >10 mil within last 2 years

               -  At least one patent fallopian tube documented by HSG or SHG

               -  Cycle length 25-35 days

             Exclusion:

               -  Irregular menstrual cycles

               -  Submucosal fibroid >3cm

               -  Stage 3-4 endometriosis

               -  BMI >40

               -  IUD within the last 3 months

               -  Less then 2 SABs including biochemical pregnancies

          3. Healthy control patients

        Inclusion:

          -  Patients who present for fertility preservation, sex selection, same sex couples
             needing fertility care, preconception counseling

          -  1 or more live births

        Exclusion:

          -  Irregular menstrual cycles

          -  Submucosal fibroid >3cm

          -  Stage 3-4 endometriosis

          -  BMI >40

          -  IUD within the last 3 months

          -  Less then 2 SABs including biochemical pregnancies

          -  No history of RPL or infertility
Female
Accepts Healthy Volunteers
Subject must be at least 18 Years old.
Subject must be at most 45 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? 1