NCT02048527

Brief Summary

Sequential culture media were introduced in order to meet the changing requirements of the developing embryo in vitro. However, there has been renewed interest in the use of single-step media, which allow the embryo itself to choose the necessary nutrients while maintaining a more stable culture environment. Previous studies suggest that sequential media do not appear superior to single-step media.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
131

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jan 2014

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

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

January 1, 2014

Completed
26 days until next milestone

First Submitted

Initial submission to the registry

January 27, 2014

Completed
2 days until next milestone

First Posted

Study publicly available on registry

January 29, 2014

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2014

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2014

Completed
Last Updated

December 16, 2014

Status Verified

December 1, 2014

Enrollment Period

9 months

First QC Date

January 27, 2014

Last Update Submit

December 15, 2014

Conditions

Infertility

Outcome Measures

Primary Outcomes (1)

  • Implantation rate per embryo transferred

    Number of fetal sacs with positive heart beat at 7 weeks of gestation

    7 weeks

Secondary Outcomes (6)

  • Blastocyst formation rate

    Day 5

  • Good quality blastocysts

    Day 5

  • Positive hCG rates

    14 days

  • Ongoing pregnancy rates

    12 weeks

  • Early pregnancy loss

    12 weeks

  • +1 more secondary outcomes

Study Arms (2)

Global

ACTIVE COMPARATOR

In vitro embryo culture in single-step medium (Global)

Other: Global

Origio

ACTIVE COMPARATOR

In vitro embryo culture in sequential media (Origio)

Other: Origio

Interventions

GlobalOTHER

Single medium for the culture of embryos from Day1 to Day 5

Also known as: Global medium (LIfeGlobal)
Global
OrigioOTHER

Sequential media medium for the culture of embryos from Day1 to Day 3 (ISM1) and from Day 3 to Day 5 (BlastAssist)

Also known as: ISM1/BlastAssist (Origio)
Origio

Eligibility Criteria

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

You may qualify if:

  • \<40 years of age
  • female infertility patients
  • at least 10 retrieved oocytes

You may not qualify if:

  • years or older
  • frozen-thawed oocytes/embryos
  • oocyte donation cycles

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Eugonia Assisted Reproduction Unit

Athens, Attica, 11528, Greece

Location

Related Publications (2)

  • Sepulveda S, Garcia J, Arriaga E, Diaz J, Noriega-Portella L, Noriega-Hoces L. In vitro development and pregnancy outcomes for human embryos cultured in either a single medium or in a sequential media system. Fertil Steril. 2009 May;91(5):1765-70. doi: 10.1016/j.fertnstert.2008.02.169. Epub 2008 Apr 25.

    PMID: 18439587BACKGROUND

  • Basile N, Morbeck D, Garcia-Velasco J, Bronet F, Meseguer M. Type of culture media does not affect embryo kinetics: a time-lapse analysis of sibling oocytes. Hum Reprod. 2013 Mar;28(3):634-41. doi: 10.1093/humrep/des462. Epub 2013 Jan 12.

    PMID: 23315059BACKGROUND

MeSH Terms

Conditions

Infertility

Condition Hierarchy (Ancestors)

Genital DiseasesUrogenital Diseases

Study Officials

  • Ioannis A Sfontouris, PhD

    Eugonia

    PRINCIPAL INVESTIGATOR

  • Trifon G Lainas, PhD

    Eugonia

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, CARE PROVIDER
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 27, 2014

First Posted

January 29, 2014

Study Start

January 1, 2014

Primary Completion

October 1, 2014

Study Completion

October 1, 2014

Last Updated

December 16, 2014

Record last verified: 2014-12

Locations

GR(1)