NCT02066584

Brief Summary

The importance of glucose in culture media on fertilization and embryo development is still controversial. Although it has been reported that glucose is essential for fertilization process and biosynthesis of membrane lipid and nucleic acids, comparatively high levels of glucose in culture media may cause developmental arrest of cleavage stage embryos. The aim of this retrospective study is to examine whether exposure of sibling oocytes to different concentrations of glucose in culture media has any further effect on IVF outcome.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
600

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Apr 2014

Geographic Reach
1 country

1 active site

Status
unknown

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

February 16, 2014

Completed
3 days until next milestone

First Posted

Study publicly available on registry

February 19, 2014

Completed
1 month until next milestone

Study Start

First participant enrolled

April 1, 2014

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2016

Completed
Last Updated

February 19, 2014

Status Verified

February 1, 2014

Enrollment Period

2 years

First QC Date

February 16, 2014

Last Update Submit

February 18, 2014

Conditions

Keywords

sibling oocytesglucoseculture media

Outcome Measures

Primary Outcomes (1)

  • Fertilization Rate

    Fertilization rates will be retrospectively compared according to culture media in which sibling oocytes were incubated

    2 years

Secondary Outcomes (1)

  • Embryo Quality

    2 years

Study Arms (4)

Universal IVF Medium

An oocyte culture medium containing 5.55 Mm glucose (Origio, Medi-Cult)

Other: Sibling oocyte incubation

ISM1 Medium

An oocyte culture medium containing 1mM glucose ((Origio, MediCult)

Other: Sibling oocyte incubation

P1 Medium

An oocyte culture medium containing no glucose (Irvine)

Other: Sibling oocyte incubation

ECM Medium

An oocyte culture medium containing 0.5mM glucose (Irvine)

Other: Sibling oocyte incubation

Interventions

ECM MediumISM1 MediumP1 MediumUniversal IVF Medium

Eligibility Criteria

Age18 Years - 42 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64)
Sampling MethodProbability Sample
Study Population

Sibling oocytes retrieved from women who have undergone IVF treatment in our IVF unit.

You may qualify if:

  • Sibling oocytes from cycles where at least 4 oocytes were retrieved

You may not qualify if:

  • Less than 4 oocytes retrieved
  • Partner has undergone testicular sperm extraction (TESE)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hillel Yaffe Medical Center

Hadera, 38100, Israel

Location

MeSH Terms

Conditions

Infertility

Condition Hierarchy (Ancestors)

Genital DiseasesUrogenital Diseases

Study Officials

  • Medeia Michaelo, PhD

    Hellel Yaffe Medical Center

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Medeia Michaeli, PhD

CONTACT

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER GOV
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 16, 2014

First Posted

February 19, 2014

Study Start

April 1, 2014

Primary Completion

April 1, 2016

Study Completion

April 1, 2016

Last Updated

February 19, 2014

Record last verified: 2014-02

Locations