Assessment of the INVOcell Intravaginal Culture System

Exclusion Criteria

• •Couples may be included in the study only if they have been informed about the study and have given their written consent.
• •Infertile couples with failure to conceive a diagnosed pregnancy after one year of unprotected intercourse (6 months if the woman's age is 35 years or more). This one-year requirement need not be fulfilled if oligomenorrhea or tubal factor is present, or donor sperm use is planned
• •IVF has been determined by the physician to be their next appropriate treatment
• •Women with desire for pregnancy using donor sperm will be eligible even absent infertility factors.
• •Women included in the study should:
• •Be between the age of 18 and 37 years (has not reached her 38th birthday at the time of enrollment).
• •Have an anti-Müllerian hormone (AMH) level ≥ 0.8 ng/mL
• •Have a normal uterine cavity as assessed in the past year by HSG, SHG or hysteroscopy. Prior tubal ligation is acceptable.
• •Partner semen analysis within the past year must show a total of ≥ 15 million motile spermatozoa.
• •Inability to read and speak English fluently
• •One (1) or more recurrent vaginitis or bacterial vaginosis (BV) requiring medical attention.
• •A history of toxic shock syndrome
• •Known allergies to plastic or silicone
• •Had pelvic surgery within the past 8 weeks, excluding laparoscopy with or without salpingectomy (ies) or hysteroscopy with or without polypectomy
• •Had pelvic inflammatory disease (PID) within the past 3 months and were treated with antibiotics
• •Severe endometriosis (stage III-IV) or endometrioma(s) (past or present)
• •Clinical signs of current vaginal infection
• •Significant abnormalities of the vaginal cavity
• •Submucous or intramural fibroids (\>2 cm diameter)
• •Hydrosalpinx
• •Uncontrolled chronic illness, e.g. autoimmune disease, diabetes. Appropriately treated hypothyroidism, hypertension, dyslipidemia, e.g., are not exclusions.
• •BMI \>36.0 kg/m2
• •Donor oocytes
• •Antral follicle count (AFC; at cycle baseline) \< 6
• •Previously assessed as having a poor response to ovarian stimulation
• •Patients with polycystic ovary syndrome (PCOS) meeting NIH (1990) criteria
• •Cervical stenosis
• •Recurrent pregnancy loss defined by recurrent non-biochemical pregnancy losses
• •Failed fertilization of all oocytes obtained in a previous IVF cycle
• •Smoke tobacco or vape, abuse drugs or alcohol
• •Inability to understand or comply with trial procedures
• •Partner with vasectomy reversal
• •Partner with inability to produce sperm specimen
• •Partner with uro-genital infection