for females ages 18-37 (full criteria)
healthy people welcome
study started
estimated completion
Marcelle Cedars, MD(ucsf)



The purpose of this study is to evaluate implantation rate with intra-vaginal culture (IVC) with the INVOcell device versus traditional In-Vitro Fertilization (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 (IVC) using INVOcell versus traditional In-Vitro Fertilization (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


Infertility INVOcell device Traditional IVF Intra-vaginal culture - INVOcell device Traditional IVF culture


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
  • Antral Follicle Count (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


  • University of California San Francisco - Center for Reproductive Health accepting new patients
    San Francisco California 94158 United States

Lead Scientist

  • Marcelle Cedars, MD (ucsf)
    Professor, Ob/Gyn, Reproductive Sciences. Authored (or co-authored) 216 research publications.


accepting new patients
Start Date
Completion Date
University of California, San Francisco
INVOcell device
University of California San Francisco Center for Reproductive Health
Study Type
Last Updated