Clinical trial: RCT to Assess the Impact of Microbiome Status in Infertile IVF Patients at Their First IVF/ICSI Cycle (NCT04686357)

Eligibility criteria:
-  Inclusion criteria

               -  Patients whose written IC approved by the EC has been obtained, after having been
                  duly informed of the nature of the study and voluntarily accepted to participate
                  after being fully aware of the potential risks, benefits and any discomfort
                  involved.

               -  Patients undergoing their first IVF/ICSI cycle (first oocyte pick up, freezing
                  all) with their own oocytes that will receive single embryo transfer of frozen
                  blastocyst stage embryos (day 5/6) on an HRT cycle.

               -  At least 2 morphologically good quality embryos already vitrified in blastocyst
                  stage (day 5/6).

               -  Maternal Age: ≤37 years to rule out embryo factor in aging patients.

               -  BMI: 18.5 - 30.0 kg / m2 (both inclusive).

               -  Normal ovarian reserve (defined as: AFC ≥ 8; AMH level ≥1.0 ng/ml and/or FSH < 8
                  mU/ml) before the controlled ovarian stimulation (COS) initiation.

               -  Serum P levels ≤ 1.5 ng/ml, measured within 24 hours before the hCG
                  administration in the COS cycle.

               -  Negative serological tests for HIV, HBV, HCV, RPR.

          -  Exclusion criteria

               -  Patients with repeated miscarriages (> 2 previous biochemical pregnancies or > 2
                  spontaneous miscarriages).

               -  Male partner with severe male factor (spermatozoa < 2 million/ml). Semen donor is
                  allowed.

               -  Patients who are intrauterine device (IUD) carriers in the last 3 months before
                  sample collection.

               -  Adenomyosis or any pathological finding affecting the endometrial cavity such as
                  polyps/sub-mucosal myomas, intramural myomas > 4 cm, or hydrosalpinx must be
                  previously operated at least 3 months before the endometrial samples are
                  obtained.(Note: Patients are allowed to participate if the pathology is corrected
                  before performing any study procedure).

               -  Embryos analysed using preimplantation genetic testing for aneuploidies (PGT-A)

               -  Women who have received antibiotics in the last month previous to sample
                  collection, except for the prophylaxis for the oocyte retrieval. In the control
                  group, antibiotics cannot be provided during the ET cycle

               -  Illness or unstable medical condition that may put at risk the patient's safety
                  and her compliance in the study
Female
Accepts Healthy Volunteers

Subject must be at most 37 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