Comparing blastocyst quality and live birth rates of intravaginal culture using INVOcell™ to traditional in vitro incubation in a randomized open-label prospective controlled trial

Abstract

PurposeThe purpose of this study is to to compare the efficacy of intravaginal culture (IVC) of embryos in INVOcell™ (INVO Bioscience, MA, USA) to traditional in vitro fertilization (IVF) incubators in a laboratory setting using a mild pre-determined stimulation regimen based solely on anti-mullerian hormone (AMH) and body weight with minimal ultrasound monitoring. The primary endpoint examined was total quality blastocysts expressed as a percentage of total oocytes placed in incubation. Secondary endpoints included percentage of quality blastocysts transferred, pregnancy, and live birth rates.MethodsIn this prospective randomized open-label controlled single-center study, 40 women aged <38 years of age with a body mass index (BMI) of <36 and an AMH of 1–3 ng/mL were randomized prior to trigger to receive either IVC or IVF. Controlled ovarian stimulation was administered with human menopausal gonadotropin (hMG) in a fixed gonadotropin-releasing hormone (GnRH) agonist cycle based solely on AMH and body weight. A single ultrasound-monitoring visit was performed on the 10th day of stimulation. One or two embryos were transferred following 5 days of culture.ResultsIVF produced a greater percentage of total quality embryos as compared to IVC (50.6 vs. 30.7 %, p = 0.0007, respectively). There was no significant difference between in IVF and IVC in the percentage of quality blastocysts transferred (97.5 vs. 84.9 %, p = 0.09) or live birth rate (60 % IVF, 55 % IVC).ConclusionsIVF was shown to be superior to IVC in creating quality blastocysts. However, both IVF and IVC produced identical blastocysts for transfer resulting in similar live birth rates. IVC using INVOcell™ is effective and may broaden access to fertility care in selected patient populations by ameliorating the need for a traditional IVF laboratory setting. Further studies will help elucidate the potential physiological, psychological, geographic, and financial impact of IVC on the delivery of fertility care.

Intravaginal culture using INVOCELL: Is it a viable treatment option for infertility?

“…Bypassing the need for IVF laboratory services seems to be an attractive strategy to decrease the cost of the treatment as long as clinical outcomes are not significantly compromised. The numbers of the current study speak for themselves and to date, only 1 other study from the United States assessed the efficacy of extended intravaginal embryo culture (5). In 40 good prognosis patients who underwent mild predetermined ovarian stimulation with single ultrasound and randomization on stimulation day 10, IVC resulted in 31% good quality blastocyst (R2BB) development rate compared with 51% for IVF (primary endpoint).…”

Can we modify assisted reproductive technology practice to broaden reproductive care access?

“…A recent prospective pilot study evaluated the efficacy of extended culture in IVC. Forty patients underwent treatment with a relatively low dose but conventional stimulation (61). On the day of hCG trigger, patients were randomized to 5-day culture in either Invocell or a traditional laboratory incubator system.…”

Vaginal culture for IVF allows two mothers to carry the same pregnancy: Is more always better?

“…Sperm was co-incubated in the INVOcell with 4 oocytes on average. This study was followed with a prospective randomized open-label controlled single-centre study done by the founder, CEO and CFO of INVOcell comparing traditional IVF with intravaginal culture (IVC) [ 6 ]. A total of 40 women aged 18–38 years were included in the study.…”

“…Following a conventional trans-cervical embryo transfer, multiple embryos were transferred in both groups (1.65 average for IVC and 1.8 average for IVF). The live birth rates were similar (60% for IVF vs 55% for IVC) [ 6 ]. Thus, the use of the INOVcell device, in the setting of mild stimulation, appears to result in acceptable live birth rates for the initial embryo transfer at a cost of reducing the overall number of good-quality embryos.…”