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Eligibility
for females ages 18–37
Healthy Volunteers
healthy people welcome
Location
at San Francisco, California
Dates
study started
estimated completion:
Principal Investigator

Description

Summary

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

Details

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

Keywords

Infertility

Eligibility

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

Location

Details

Status
accepting new patients
Start Date
Completion Date
(estimated)
Sponsor
University of California, San Francisco
Links
INVOcell device
University of California San Francisco Center for Reproductive Health
ID
NCT02802176
Phase
Phase 4
Lead Scientist
Marcelle Cedars
Study Type
Interventional
Last Updated
September 12, 2016
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