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for females ages 18–37 (full criteria)
healthy people welcome
at San Francisco, California
study started
estimated completion:



The purpose of this study is to evaluate implantation rate with intra-vaginal culture with the INVOcell device versus traditional IVF while using minimal stimulation protocols

Official Title

Randomized Controlled Trial Comparing Intra-vaginal Culture of Embryos Using INVOcell Device to In-vitro Culture of Embryos Using Minimal Stimulation Protocols


This is a Phase IV, single center randomized controlled trial evaluating intra-vaginal culture using INVOcell versus traditional IVF using oral stimulation or minimal gonadotropin stimulation protocols. The pilot aims to includes 40 women who will be randomized to either the intra-vaginal culture group (N=20) using INVOcell or to the traditional IVF group (N=20).

Primary aim is implantation rate, which is defined by number gestational sacs seen on early pregnancy ultrasound divided by number of embryos transferred.

Secondary aims are:

  • Embryo quality, which is measured by the Gardner grading system.
  • Fertilization rate, which is defined by the total number of fertilized oocytes divided by total number of mature oocytes retrieved. This comparison will take place on day-3, as that is when the IVC embryos will be assessed.
  • Clinical pregnancy rate, which is defined by the number of fetal poles with heartbeat seen on ultrasound divided by the number of embryos transferred.
  • Live birth rate, which is defined by the number of living babies delivered divided by the number of transfers




You can join if…

Open to females ages 18–37

  • Normal uterine cavity
  • One or more years of infertility
  • Normal male partner semen analysis

You CAN'T join if...

  • Age <18 years old or >37 years old
  • AFC <8
  • Abnormal male partner semen analysis or use of donor sperm
  • Vaginal inflammation or genital (vaginal, uterine, tubal) infection
  • Uncontrolled chronic disease (such as uncontrolled diabetes or hypertension)
  • Uterine anatomic abnormalities
  • Allergy to plastics or inability to use diaphragm retention device
  • Untreated hydrosalpinx
  • Current alcohol abuse (defined by >14 drinks/week)
  • Prior history of IVF cycle where fertilization did not occur
  • History of recurrent pregnancy loss



accepting new patients
Start Date
Completion Date
University of California, San Francisco
INVOcell device
University of California San Francisco Center for Reproductive Health
Phase 4
Lead Scientist
Marcelle Cedars
Study Type
Last Updated
September 2016
I’m interested in this study!