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.
Highlights
The process of in vitro fertilization (IVF) where oocytes and sperm are incubated in a laboratory setting is necessary to achieve pregnancy for many patients with infertility
IVF produced a greater percentage of total quality embryos as compared to intravaginal culture (IVC) (50.6 vs. 30.7 %, p = 0.0007, respectively)
One hundred and twenty seven (127) oocytes were placed in the vaginal culture device INVOcellTM, and 156 oocytes were incubated in a traditional IVF culture system
Summary
The process of in vitro fertilization (IVF) where oocytes and sperm are incubated in a laboratory setting is necessary to achieve pregnancy for many patients with infertility. The expense and overall burden of IVF significantly restricts access to assisted reproductive technologies (ART) [1]. The modern IVF laboratory requires expensive air filtration systems [2], as the embryo has no lung, kidney, or liver to filter air contaminants including volatile organic compounds. Incubators require alarm systems, daily quality control checks, and 24/7 monitoring. If intracytoplasmic sperm injection (ICSI) or similar micromanipulation is offered, highly trained embryologists with. Access to fertility programs offering IVF is generally restricted from a geographic perspective to large urban centers and from a financial perspective to those who can afford this treatment
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