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

This study is currently recruiting participants.
Verified October 2017 by Marcell Cedars, M.D., University of California, San Francisco
Sponsor:
ClinicalTrials.gov Identifier:
NCT02802176
First Posted: June 16, 2016
Last Update Posted: October 26, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
Information provided by (Responsible Party):
Marcell Cedars, M.D., University of California, San Francisco
  Purpose
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

Condition Intervention Phase
Infertility Device: INVOcell device Other: Traditional IVF Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description:
Arm 1: intra-vaginal culture using INVOcell device. Arm 2: Traditional IVF culture in an embryology laboratory
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Randomized Controlled Trial Comparing Intra-vaginal Culture of Embryos Using INVOcell Device to In-vitro Culture of Embryos Using Minimal Stimulation Protocols

Further study details as provided by Marcell Cedars, M.D., University of California, San Francisco:

Primary Outcome Measures:
  • Implantation rate [ Time Frame: approximately 4 weeks following randomization ]
    defined by number gestational sacs seen on early pregnancy 6-week ultrasound divided by number of embryos transferred


Secondary Outcome Measures:
  • Embryo quality [ Time Frame: measured after 3 days of incubation ]
    quality determined using Gardner grading system

  • Fertilization rate [ Time Frame: measured after 3 days of incubation ]
    defined by the total number of fertilized oocytes divided by total number of mature oocytes retrieved

  • Clinical pregnancy rate [ Time Frame: approximately 4 weeks following randomization ]
    which is defined by the number of fetal poles with heartbeat seen on 6-week ultrasound divided by the number of embryos transferred

  • Live birth rate [ Time Frame: 9 months after embryo transfer ]
    which is defined by the number of living babies delivered divided by the number of transfers


Estimated Enrollment: 40
Study Start Date: July 2016
Estimated Study Completion Date: December 2018
Estimated Primary Completion Date: March 2018 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Intra-vaginal culture - INVOcell device
3 day intra-vaginal incubation using the INVOcell device
Device: INVOcell device
intra-vaginal culture of embryos using INVOcell device
Active Comparator: Traditional IVF culture
3 day traditional IVF incubation
Other: Traditional IVF
traditional culture of embryos in-vitro

Detailed Description:

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
  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 37 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

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
  • 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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02802176


Contacts
Contact: Asima K Ahmad, MD, MPH 4153537475 asima.ahmad@ucsf.edu
Contact: Marcelle Cedars, MD 4153537475

Locations
United States, California
University of California San Francisco - Center for Reproductive Health Recruiting
San Francisco, California, United States, 94158
Contact: Asima K Ahmad, MD, MPH    415-353-7475    crh.research@ucsf.edu   
Contact: Nikolaus Lenhart    4153537475    nikolaus.lenhart@ucsf.edu   
Sponsors and Collaborators
University of California, San Francisco
  More Information

Additional Information:
Responsible Party: Marcell Cedars, M.D., Director of the UCSF Center for Reproductive Health, University of California, San Francisco
ClinicalTrials.gov Identifier: NCT02802176     History of Changes
Other Study ID Numbers: IRB 166094
First Submitted: June 12, 2016
First Posted: June 16, 2016
Last Update Posted: October 26, 2017
Last Verified: October 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Additional relevant MeSH terms:
Infertility
Genital Diseases, Male
Genital Diseases, Female