Table 2.
The most common demographics/characteristics for INVOCELL patients across the 5 sites.
| Patient Characteristics | 1 | 2 | 3 | 4 | 5 |
|---|---|---|---|---|---|
| Age (y) | 35 (26–48) | 33.9 (23–50) | 32.5 (24–44) | 34.4 (24.5–43.5) | 33.7 (26–40) |
| BMI (kg/m2) | 29.9 (18.9–45.4) | 31 (19.6–43.1) | 25.8 (18.3–38.3) | 26.2 (17.5–36.0) | 30.02 (18.33–41.53) |
| Ovarian reserve (AMH) | 2.74 (0.28–8.08) | 3.9 (0.01–22.9) | 5.0 (0.67–45.6) | 3.03 (0.23–17.5) | 4.83 (0.32–13.24) |
| Infertility diagnosis (%) | |||||
| Tubal factor | 56.2% | 17.6% | 31% | 28.4% | 4% |
| Unexplained | 20.5% | 15.2% | 13% | 24.9% | N/A |
| Diminished ovarian reserve | 2.7% | 10.3% | 4% | 4.5% | 24% |
| PCOS/ovulatory dysfunction | 5.5% | 21.8% | 19% | 18.9% | 36% |
| Endometriosis | N/A | 2% | N/A | 6.5% | 4% |
| Other | N/A | 1% | N/A | 1.5% | 8% |
| Male factor | 15% | 32% | 33% | 6.5% | 24% |
| Donor sperm | |||||
| Donor sperm: absence of male partner | 100% | 73% | 78% | 84% | 80% |
| Donor sperm: abnormal sperm parameters | 0% | 27% | 22% | 16% | 20% |
Note: Inclusion criteria for use of INVOCELL typically included young patients (<38 years) with a BMI <35 kg/m2 and an adequate ovarian reserve. Exclusion criteria typically included older patients (age ≥ 38 years), with diminished ovarian reserve (AMH < 0.8 ng/mL), BMI >35 kg/m2, and moderate-to-severe male factor infertility, except when using donor sperm. With increasing comfort using intravaginal culture, some sites expanded the scope of indications to include PCOS and social and religious indications. Percentages represent primary diagnosis. Donor sperm was used primarily in cases because of absence of a male partner. AMH = anti-Mullerian hormone; BMI = body mass index; N/A = not available/not applicable; PCOS = polycystic ovary syndrome.