NCT01773603

Brief Summary

Choosing the best embryo for transfer has become the major challenge in in vitro fertilization (IVF). Morphology alone is obviously not enough and time-lapse incubation has added embryo development kinetics as another selection criterion. This study was designed to select for the top blastocyst to be replaced, while increasing the pregnancy chance, with the local legislation regulating the number of embryos to be transferred and to establish a morphokinetic standard to be used in our clinical setting.

Trial Health

57
Monitor

Trial Health Score

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

Enrollment
64

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Dec 2011

Shorter than P25 for not_applicable

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

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 1, 2011

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2012

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2012

Completed
7 months until next milestone

First Submitted

Initial submission to the registry

January 18, 2013

Completed
5 days until next milestone

First Posted

Study publicly available on registry

January 23, 2013

Completed
Last Updated

January 23, 2013

Status Verified

January 1, 2013

Enrollment Period

6 months

First QC Date

January 18, 2013

Last Update Submit

January 18, 2013

Conditions

Infertility

Keywords

Time-lapsemorphokineticsblastocyst transfereSET

Outcome Measures

Primary Outcomes (1)

  • Blastocyst formation rate

    5th day of embryonic development

Secondary Outcomes (1)

  • Clinical pregnancy rate

    7th week of pregnancy

Study Arms (2)

Conventional incubation

NO INTERVENTION

Five-day embryo culture in conventional incubators

Embryoscope

ACTIVE COMPARATOR

Five-day embryo culture in embryoscope which is an incubator with a built-in camera

Device: Embryoscope

Interventions

EmbryoscopeDEVICE

Five-day embryo culture in embryoscope which is an incubator with a built-in camera

Also known as: Time-lapse monitoring of human embryos in Embryoscope
Embryoscope

Eligibility Criteria

Age20 Years - 35 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • patients in their first or second ART treatment cycle
  • no recurrent spontaneous abortions
  • age\<35 years
  • BMI\<28 kg/m2
  • ≥8 oocytes retrieved

You may not qualify if:

  • severe endometriosis
  • polycystic ovary syndrome
  • hydrosalpynx
  • uterine pathology
  • severe male factor (presenting less than 5 million motile sperm cells in total in the ejaculate)
  • very severe morphological sperm defects (mainly globozoospermic or macrocephalic samples)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Sisli Memorial Hospital

Istanbul, 34385, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Infertility

Interventions

Fetoscopes

Condition Hierarchy (Ancestors)

Genital DiseasesUrogenital Diseases

Intervention Hierarchy (Ancestors)

EndoscopesDiagnostic EquipmentEquipment and SuppliesSurgical Equipment

Study Officials

  • Semra Kahraman, MD, Prof

    Sisli Memorial Hospital

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
R&D Laboratory Manager

Study Record Dates

First Submitted

January 18, 2013

First Posted

January 23, 2013

Study Start

December 1, 2011

Primary Completion

June 1, 2012

Study Completion

July 1, 2012

Last Updated

January 23, 2013

Record last verified: 2013-01

Locations

TU(1)