NCT02457481

Brief Summary

The purpose of this research study is to evaluate a newly developed embryo culture media system for human clinical use in ART.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
100

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started May 2015

Longer than P75 for not_applicable

Geographic Reach
1 country

2 active sites

Status
completed

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

Study Start

First participant enrolled

May 1, 2015

Completed
12 days until next milestone

First Submitted

Initial submission to the registry

May 13, 2015

Completed
16 days until next milestone

First Posted

Study publicly available on registry

May 29, 2015

Completed
3.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2018

Completed
Last Updated

August 28, 2018

Status Verified

August 1, 2018

Enrollment Period

3.3 years

First QC Date

May 13, 2015

Last Update Submit

August 27, 2018

Conditions

InfertilityReproductive Techniques, Assisted

Keywords

Embryo Culture TechniquesEmbryonic Development

Outcome Measures

Primary Outcomes (4)

  • embryo development

    Blastocyst development and quality on days 5 and 6 of culture

    7 days after egg retrieval

  • pregnancy rate

    The incidence of implantation and pregnancy following embryo transfer, including initial pregnancy test and ultrasound examination.

    2 months after egg retrieval

  • offspring weight

    The birth weight of children born

    1 year after egg retrieval

  • offspring gender

    The gender of children born

    1 year after egg retrieval

Secondary Outcomes (2)

  • fertilization

    2 days after egg retrieval

  • euploid embryos

    1 month after egg retrieval

Study Arms (1)

Embryo Culture medium

EXPERIMENTAL

Embryos from each patient are randomly allocated to culture in the commercial or experimental embryo culture medium (half of the embryos in commercial and half in experimental medium).

Device: Embryo Culture medium

Interventions

Embryo Culture mediumDEVICE

Two step sequential embryo culture medium system

Embryo Culture medium

Eligibility Criteria

Age18 Years+
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Adult women of any age who come to Colorado Center for Reproductive Medicine for fertility treatment using IVF.
  • Patients can be of any race, culture, sexual orientation or ethnicity.

You may not qualify if:

  • Minors are excluded from the study

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Fertility Laboratories of Colorado

Lone Tree, Colorado, 80124, United States

Location

National Fooundation for Fertility Research

Lone Tree, Colorado, 80124, United States

Location

MeSH Terms

Conditions

InfertilityHelping Behavior

Condition Hierarchy (Ancestors)

Genital DiseasesUrogenital DiseasesSocial BehaviorBehavior

Study Officials

  • Rebecca L Krisher, PhD

    NFFR

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 13, 2015

First Posted

May 29, 2015

Study Start

May 1, 2015

Primary Completion

August 1, 2018

Study Completion

August 1, 2018

Last Updated

August 28, 2018

Record last verified: 2018-08

Locations

US(2)