Clinical trial: Clinical Study of Umbilical Cord Mesenchymal Stem Cells Combined With Collagen Scaffold in the Treatment of Thin Endometrium (NCT03724617)

Eligibility criteria:
Inclusion Criteria:

          1. According to the GCP regulations, obtain the informed consent of the subject,
             volunteer for the test, and have signed the informed consent form.

          2. Women aged 20-40 years with fertility requirements

          3. Infertility patients who are treated in this hospital

          4. After more than 2 times of hysteroscopic adhesion separation surgery, the uterine
             cavity morphology has basically returned to normal. The patient has a normal menstrual
             cycle or an estrogenic dose of 6 mg per day, and the highest thickness of the
             endometrium is 5.5 mm in 6 cycles by ultrasound.

          5. or receive adjuvant reproductive treatment, the endometrial thickness is less than
             5.5mm for unknown reasons, the treatment of estrogen, colony stimulating factor,
             aspirin, sildenafil and other drugs up to 8mg / day is invalid.

          6. HBVAg negative, HCV negative, HIV negative, syphilis negative

          7. Normal bone marrow morphology, normal blood routine

          8. Previously failed to receive relevant stem cell therapy

        Exclusion Criteria:

          1. Those who cannot accept the treatment observation process required by the test

          2. There are contraindications for hysteroscopic surgery;

          3. congenital uterine malformation; severe adenomyosis; uterine fibroids that may affect
             embryo implantation; the investigators judged that there are other uterine factors
             that are not suitable for embryo implantation

          4. Patients with chromosomal abnormalities

          5. contraindications to estrogen therapy; systemic diseases such as thrombosis,
             cardiopulmonary disease, hematopoietic diseases, malignant tumors, etc.

          6. Patients without fertility requirements
Female
No healthy subjects accepted to join the trial.
Subject must be at least 20 Years old.
Subject must be at most 40 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? Entailment