NCT02050516

Brief Summary

Does group culture using micro-well group culture dishes improve human blastocyst development compared to single embryo culture?

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
160

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jul 2013

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

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2013

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2014

Completed
28 days until next milestone

First Submitted

Initial submission to the registry

January 29, 2014

Completed
1 day until next milestone

First Posted

Study publicly available on registry

January 30, 2014

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2014

Completed
Last Updated

January 31, 2014

Status Verified

January 1, 2014

Enrollment Period

6 months

First QC Date

January 29, 2014

Last Update Submit

January 30, 2014

Conditions

Infertility

Keywords

Blastocyst, micro-well group culture dish

Outcome Measures

Primary Outcomes (1)

  • Blastocyst development

    6 days

Secondary Outcomes (1)

  • Implantation rate

    1 month

Other Outcomes (1)

  • Clinical pregnancy rate

    1 month

Study Arms (2)

single embryo culture

ACTIVE COMPARATOR

single embryo culture in single drops inside micro-well group culture dish

Other: micro-well group culture dish

group embryo culture

EXPERIMENTAL

group embryo culture in a single drop inside micro-well group culture dish

Other: micro-well group culture dish

Interventions

micro-well group culture dishOTHER

an embryo culture dish containing nine micro-wells in the middle.

group embryo culturesingle embryo culture

Eligibility Criteria

Age18 Years - 39 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Eurofertil IVF Health Center

Istanbul, Turkey (Türkiye)

RECRUITING

MeSH Terms

Conditions

Infertility

Condition Hierarchy (Ancestors)

Genital DiseasesUrogenital Diseases

Study Officials

  • Elif Güler Ergin, MD

    Eurofertil IVF Health Center

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Elif Güler Ergin, MD

CONTACT

+90 5327882101drelifergin@gmail.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
MD

Study Record Dates

First Submitted

January 29, 2014

First Posted

January 30, 2014

Study Start

July 1, 2013

Primary Completion

January 1, 2014

Study Completion

July 1, 2014

Last Updated

January 31, 2014

Record last verified: 2014-01

Locations

TU(1)