Clinical trial: Effects of PGS in Infertile Female Patients With RPL (NCT02223221)

Eligibility criteria:
Inclusion Criteria:

        Women 18-48 years of age who are scheduled for IVF or ICSI with a history of recurrent
        spontaneous abortion (continous miscarriage occurred earlier than 20 weeks of gestation for
        equal or greater than 2 times) in our IVF institute while meeting the following criteria:

          1. regular menstrual cycles and normal level of E2, P, FSH, LH, T, RPL in the early
             follicular phase;

          2. no history of hormone medicine application in the last 3 months;

          3. no history of poison contact;

          4. normal uterine and adnexal ultrasonography;

          5. TORCH(-), chlamydia(-), mycoplasma(-), normal leucorrhoea routine, anti-phospholipid
             antibody (-), antinuclear antibody(-);

          6. for the couple, no blood type incompatibility or ABO antibody IgG≤1：64 and normal
             blood chromosome analysis.

        Exclusion Criteria:

          1. hydrosalpinx without operation; endometriosis; polycystic ovary syndrome; adenomyosis;
             uterine leiomyomata(submucous myoma or non-submucous myoma which size was exceed 4cm
             and/or with the compressed endometrium);uterine cavity lesions(such as uterine
             malformation, intrauterine adhesions, the septate uterus, endometritis etc);

          2. the former abortion is because of luteal phase defect without treatment;

          3. thyroid dysfunction or increased CA125 level;

          4. acute inflammation of genitourinary system or STD carriers;

          5. unable to comply with the study procedures.
Female
No healthy subjects accepted to join the trial.
Subject must be at least 18 Years old.
Subject must be at most 48 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