NCT02527642

Brief Summary

This is a randomized, controlled, single-center study in otherwise healthy infertile female subjects undergoing in vitro fertilization (IVF). The subjects recruited for this study will be among those patients who have been diagnosed with infertility and are planning to undergo IVF at the centers where this study is being performed. The patients will have undergone the usual informed consent procedure at the center.

Trial Health

57
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Trial Health Score

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

Enrollment
13

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jul 2015

Geographic Reach
1 country

1 active site

Status
terminated

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

July 1, 2015

Completed
27 days until next milestone

First Submitted

Initial submission to the registry

July 28, 2015

Completed
22 days until next milestone

First Posted

Study publicly available on registry

August 19, 2015

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 17, 2016

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2017

Completed
Last Updated

May 1, 2017

Status Verified

April 1, 2017

Enrollment Period

1.3 years

First QC Date

July 28, 2015

Last Update Submit

April 27, 2017

Conditions

Infertility

Outcome Measures

Primary Outcomes (1)

  • Embryo development

    Comparison of embryo development using standard assessments of morphokenetics of embryo development

    1 year

Secondary Outcomes (2)

  • Embryo transfer rate

    1 year

  • Clinical pregnancy rates

    within 3 months of embryo transfer

Other Outcomes (1)

  • Number of participants pregnant after Frozen Embryo Transfer

    2 years

Study Arms (4)

CRM sequential media (C1/C2)

ACTIVE COMPARATOR

CRM sequential media, formulated according to the stages of embryo development, is used to culture the embryos from oocyte fertilization to blastocyst stage.

Other: embryo culture in buffered media

CRM single step media (C3)

ACTIVE COMPARATOR

CRM single step media is used to culture the embryos from oocyte fertilization to blastocyst stage.

Other: embryo culture in buffered media

Vitrolife media G1/2 Sequential

EXPERIMENTAL

Vitrolife sequential media, formulated according to the stages of embryo development, is used to culture the embryos from oocyte fertilization to blastocyst stage.

Other: embryo culture in buffered media

Vitrolife G-TL Time Lapse media Single Step

EXPERIMENTAL

G-TL Time Lapse Single step (time lapse) media is formulated for continuous culture from oocyte fertilization to blastocyst stage.

Other: embryo culture in buffered media

Interventions

embryo culture in buffered mediaOTHER

compare media that supports human embryo development in the laboratory (in vitro) using Time-Lapse system.

Also known as: Embryo media- CRM media vs Vitrolife
CRM sequential media (C1/C2)CRM single step media (C3)Vitrolife G-TL Time Lapse media Single StepVitrolife media G1/2 Sequential

Eligibility Criteria

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

You may qualify if:

  • years of age or younger (maternal) 65 years of age or younger (paternal)
  • Patient must have 10 or greater than 10 mature oocytes, ICSI only
  • Fresh or frozen (including donor) sperm can be used. Fresh oocytes only (including donor)
  • Frozen embryos from this study can be included in the outcome portion of this study.
  • Single or double Blastocyst transfer only

You may not qualify if:

  • Patients having PGS (Pre-implantation Genetic Screening)
  • or more previous failed cycles
  • Sperm obtained by testicular biopsy
  • Previous enrollment in the study
  • Non blastocyst transfer
  • Co-culture patients
  • Multi-source media transfers if researchers are unable to determine the media source after transfer.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Center fo Reproductive Medicine

New York, New York, 10021, United States

Location

MeSH Terms

Conditions

Infertility

Condition Hierarchy (Ancestors)

Genital DiseasesUrogenital Diseases

Study Officials

  • Nikica Zaninovic, PhD

    Weill Medical College of Cornell University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 28, 2015

First Posted

August 19, 2015

Study Start

July 1, 2015

Primary Completion

October 17, 2016

Study Completion

April 1, 2017

Last Updated

May 1, 2017

Record last verified: 2017-04

Data Sharing

IPD Sharing
Will not share

Locations

US(1)