NCT02516020

Brief Summary

To compare the effectiveness of single step culture media and continuous uninterrupted culture media on blastulation rate

Trial Health

30
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Timeline
Completed

Started Aug 2015

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withdrawn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

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2015

Completed
2 days until next milestone

First Submitted

Initial submission to the registry

August 3, 2015

Completed
2 days until next milestone

First Posted

Study publicly available on registry

August 5, 2015

Completed
12 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2016

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2016

Completed
Last Updated

April 18, 2017

Status Verified

April 1, 2017

Enrollment Period

1 year

First QC Date

August 3, 2015

Last Update Submit

April 17, 2017

Conditions

Infertility

Keywords

IVFICSIculture mediasequential

Outcome Measures

Primary Outcomes (1)

  • The blastulation rate

    The blastulation rate is defined as the number of blastocysts from 2 pronuclei (2PN) zygotes

    116 ±1 hours after ICSI

Secondary Outcomes (2)

  • Implantation rate

    11 days after embryo transfer

  • Clinical pregnancy

    7 weeks after embryo transfer

Study Arms (2)

Global

ACTIVE COMPARATOR

EmbryoSingle step culture medium Embryos are cultured in single step culture from day 1 to day 5 Other Name: Global medium (LifeGlobal)

Drug: Global

Origio

ACTIVE COMPARATOR

Sequential media Embryos are cultured in sequential medium from Day1 to Day 3 and from Day 3 to Day 5 (Sequential Blast) Other Name: Sequential Blast (Origio)

Drug: Origio

Interventions

GlobalDRUG

Embryos are cultured in single step culture from day 1 to day 5

Also known as: Global medium (LifeGlobal)
Global
OrigioDRUG

Embryos are cultured in sequential medium from Day1 to Day 3 and from Day 3 to Day 5 (Sequential Blast)

Also known as: Sequential Blast (Origio)
Origio

Eligibility Criteria

Age18 Years - 42 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • Number of previous failure IVF cycles ≤2
  • Using Gonadotropin-releasing hormone (GnRH) - Antagonist protocol for IVF
  • Using GnRH for oocyte triggering.
  • Read and sign consent form to participate in the study and have not been recruited for any other researches.

You may not qualify if:

  • Oocyte donation cycles
  • Abnormal uterine.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

My Duc Hospital

Ho Chi Minh City, Vietnam

Location

MeSH Terms

Conditions

Infertility

Condition Hierarchy (Ancestors)

Genital DiseasesUrogenital Diseases

Study Officials

  • Tuong M Ho, MD

    Research Center for Genetics and Reproductive Health

    PRINCIPAL INVESTIGATOR
0

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Doctor

Study Record Dates

First Submitted

August 3, 2015

First Posted

August 5, 2015

Study Start

August 1, 2015

Primary Completion

August 1, 2016

Study Completion

December 1, 2016

Last Updated

April 18, 2017

Record last verified: 2017-04

Locations

VN(1)