NCT02028897

Brief Summary

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.

Trial Health

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Geographic Reach
1 country

1 active site

Status
withdrawn

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 6, 2014

Completed
1 day until next milestone

First Posted

Study publicly available on registry

January 7, 2014

Completed
12 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2015

Completed
Last Updated

January 8, 2015

Status Verified

January 1, 2015

First QC Date

January 6, 2014

Last Update Submit

January 7, 2015

Conditions

Infertility

Keywords

In vitro fertilizationIVFEmbryo cultureBlastocyst transfer

Outcome Measures

Primary Outcomes (1)

  • Blastulation rate

    Proportion of cultured embryos that form blastocysts.

    5 days (sixth day of embryo development)

Secondary Outcomes (2)

  • Blastocyst morphology

    5 days (sixth day of development)

  • IVF outcome

    7 weeks post-transfer

Study Arms (2)

Conventional embryo culture

ACTIVE COMPARATOR

Conventional embryo culture in dishes, in droplets under oil.

Other: Conventional embryo culture

Alternative embryo culture

EXPERIMENTAL

Embryo culture in system using small enclosed containers

Other: Enclosed embryo culture

Interventions

Conventional embryo cultureOTHER
Conventional embryo culture
Enclosed embryo cultureOTHER
Alternative embryo culture

Eligibility Criteria

Age18 Years - 40 Years
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • 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.

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Fertility Center of Las Vegas

Las Vegas, Nevada, 89117, United States

Location

MeSH Terms

Conditions

Infertility

Condition Hierarchy (Ancestors)

Genital DiseasesUrogenital Diseases

Study Officials

  • Bruce Shapiro, MD, PhD

    Fertility Center of Las Vegas

    PRINCIPAL INVESTIGATOR
0

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Medical Director

Study Record Dates

First Submitted

January 6, 2014

First Posted

January 7, 2014

Primary Completion

January 1, 2015

Last Updated

January 8, 2015

Record last verified: 2015-01

Locations

US(1)