Comparing Intra-vaginal Culture of Embryos to In-vitro Culture of Embryos With Minimal Stimulation

  • STATUS
    Recruiting
  • End date
    Mar 1, 2022
  • participants needed
    34
  • sponsor
    University of California, San Francisco
Updated on 1 August 2021
cavities
semen analysis
in vitro fertilization

Summary

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

Description

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

Details
Condition Female Genital Diseases, Infertility, Gynecological Infections, sterility, unable to conceive
Treatment INVOcell device, Traditional IVF
Clinical Study IdentifierNCT02802176
SponsorUniversity of California, San Francisco
Last Modified on1 August 2021

Eligibility

Yes No Not Sure

Inclusion Criteria

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

Exclusion Criteria

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
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