title: 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: OBJECTIVE
  The 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.
  
  
  METHODS
  In 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.
  
  
  RESULTS
  IVF 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).
  
  
  CONCLUSIONS
  IVF 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.
authors: Center for Assisted Reproduction, 1701 Park Place Ave, Bedford, TX, 76022, USA. kevind@embryo.net.
authors: Kevin J
authors: KJ
authors: Doody
authors: Kelowna Regional Fertility Centre, Kelowna, BC, Canada.
authors: E Jason
authors: EJ
authors: Broome
authors: Center for Assisted Reproduction, 1701 Park Place Ave, Bedford, TX, 76022, USA.
authors: Kathleen M
authors: KM
authors: Doody
mesh_terms: D000328:Adult; D054304:Anti-Mullerian Hormone / Q000097:blood; D001723:Birth Rate; D001755:Blastocyst; D004624:Embryo Transfer; D005260:Female; D005307:Fertilization in Vitro; D007987:Gonadotropin-Releasing Hormone / Q000097:blood; D006801:Humans; D010062:Ovulation Induction; D011247:Pregnancy; D027724:Reproductive Techniques, Assisted
chemical_list: D007987:Gonadotropin-Releasing Hormone; D054304:Anti-Mullerian Hormone
keywords: Assisted reproductive technology; INVO; INVOcell; IVC; IVF; In vitro fertilization; Intravaginal culture; Mild stimulation; Minimal monitoring