Comparison of Alternative Embryo Culture Systems

January 7, 2015 updated by: Bruce Shapiro M.D.
This study will compare two alternative embryo culture systems. Embryos from each patient will be randomly assigned to one of two systems. One group will be cultured conventionally in oil-covered droplets in dishes. The other group will be assigned to an enclosed system.

Study Overview

Status

Withdrawn

Conditions

Intervention / Treatment

Detailed Description

Qualifying and consenting IVF patients will have approximately half of their developing embryos cultured in droplets covered with oil. The other approximate half of their embryos will be cultured in small enclosed containers. Embryo assignments will be at random. Regardless of culture system, all embryos will be cultured from the bipronuclear stage to the blastocyst stage in the same (Global) media, without the usual refreshing of media on day 3.

Study Type

Interventional

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Nevada
      • Las Vegas, Nevada, United States, 89117
        • Fertility Center of Las Vegas

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 40 years (Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

Female

Description

Inclusion Criteria:

  • Female age 18 to 40, seeking IVF treatment
  • Ability to understand English (to obtain informed consent)
  • Use of an oocyte donor, sperm donor, gestational carrier, and/or genetic testing (with blastocyst biopsy only) are allowed.

Exclusion Criteria:

  • Diminished ovarian reserve as evidenced by either elevated cycle day 3 follicle stimulating hormone (FSH) level (≥10 IU/L) or low antral follicle count (<8 antral follicles)
  • Fewer than five (5) bipronuclear oocytes
  • Day 3 embryo biopsy for any reason
  • No minors may enroll

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Conventional embryo culture
Conventional embryo culture in dishes, in droplets under oil.
Other: Conventional embryo culture
Experimental: Alternative embryo culture
Embryo culture in system using small enclosed containers
Other: Enclosed embryo culture

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Blastulation rate
Time Frame: 5 days (sixth day of embryo development)
Proportion of cultured embryos that form blastocysts.
5 days (sixth day of embryo development)

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Blastocyst morphology
Time Frame: 5 days (sixth day of development)
Inner cell mass size, number of trophectoderm cells, blastocyst diameter
5 days (sixth day of development)
IVF outcome
Time Frame: 7 weeks post-transfer
The result of the IVF cycle as no pregnancy, early pregnancy loss, or ongoing pregnancy at 10 weeks gestation (about 7 weeks post-transfer).
7 weeks post-transfer

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Bruce Shapiro M.D.

Investigators

  • Principal Investigator: Bruce Shapiro, MD, PhD, Fertility Center of Las Vegas

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Primary Completion (Anticipated)

January 1, 2015

Study Registration Dates

First Submitted

January 6, 2014

First Submitted That Met QC Criteria

January 6, 2014

First Posted (Estimate)

January 7, 2014

Study Record Updates

Last Update Posted (Estimate)

January 8, 2015

Last Update Submitted That Met QC Criteria

January 7, 2015

Last Verified

January 1, 2015

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • SAIRB-13-0040

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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