Blastocyst Culture Using Time-lapse in Good Prognosis IVF Patients and Elective Single Embryo Transfer

January 18, 2013 updated by: Dr. Murat Çetinkaya

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.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

64

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Turkey
      • Istanbul, Turkey, 34385
        • Sisli Memorial Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

20 years to 35 years (ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

Inclusion Criteria:

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

Exclusion Criteria:

  • 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)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
NO_INTERVENTION: Conventional incubation
Five-day embryo culture in conventional incubators
ACTIVE_COMPARATOR: Embryoscope
Five-day embryo culture in embryoscope which is an incubator with a built-in camera
Device: Embryoscope
Five-day embryo culture in embryoscope which is an incubator with a built-in camera
Other Names:
  • Time-lapse monitoring of human embryos in Embryoscope

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Blastocyst formation rate
Time Frame: 5th day of embryonic development
5th day of embryonic development

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Clinical pregnancy rate
Time Frame: 7th week of pregnancy
Clinical pregnancy was defined as the presence of a gestational sac detected on ultrasound 3 weeks after the first βhCG test, which was performed 14 days after oocyte retrieval.
7th week of pregnancy

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Dr. Murat Çetinkaya

Investigators

  • Study Director: Semra Kahraman, MD, Prof, Sisli Memorial Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

December 1, 2011

Primary Completion (ACTUAL)

June 1, 2012

Study Completion (ACTUAL)

July 1, 2012

Study Registration Dates

First Submitted

January 18, 2013

First Submitted That Met QC Criteria

January 18, 2013

First Posted (ESTIMATE)

January 23, 2013

Study Record Updates

Last Update Posted (ESTIMATE)

January 23, 2013

Last Update Submitted That Met QC Criteria

January 18, 2013

Last Verified

January 1, 2013

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • MC0405
  • IMH2013-1 (OTHER: Sisli Memorial Hospital)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Infertility

Clinical Trials on Embryoscope

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Jordan

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe