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Morphometrics and Morphokinetics of Thawed Oocytes and Embryos

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ClinicalTrials.gov Identifier: NCT02639715
Recruitment Status : Completed
First Posted : December 24, 2015
Last Update Posted : December 24, 2015
Sponsor:
Information provided by (Responsible Party):
Sophie Debrock, KU Leuven

Brief Summary:

The aim of this observational study is to describe for the first time a complete set of morphometric and morphokinetic parameters of frozen-thawed human embryos in order to select the embryo with the highest implantation potential. These parameters will be correlated with (1) data of the fresh embryos and their subsequent survival, the evolution of the contact surfaces between surviving blastomeres and the resumption of mitosis; (2) patient characteristics and clinical outcome of frozen-thawed embryos and (3) a comparison between embryos cryopreserved with vitrification or the slow method regarding these parameters will be performed.

This project aims to introduce new evaluation criteria of the frozen-thawed embryos to improve success rate of FET cycles. By establishing new precise, reliable and non-invasive measurable parameters, we aim to (1) select which supernumerary embryos are at chance to survive the freezing/thawing procedures, (2) establish cut off parameters for the survival rate of the embryo, (3) assess implantation, pregnancy and live birth rates depending on the developmental characteristics after thawing and after 24h of culture.

Our strategy for improving the outcome of FET cycles is based on the study of morphometric and morphokinetic parameters in frozen-thawed embryos and the correlation with embryological, clinical and cycle parameters. Transferring a well-defined thawed embryo with a high implantation potential may lead towards an increase in the implantation and life birth rate and an increase in the cumulative live birth rate with a reduction of the IVF costs in order to optimize the health-economic situation of reproductive medicine.


Condition or disease
Infertility

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Study Type : Observational
Actual Enrollment : 1272 participants
Observational Model: Cohort
Time Perspective: Retrospective
Official Title: Morphometrics and Morphokinetics of Thawed Oocytes and Embryos
Study Start Date : January 2014
Actual Primary Completion Date : December 2014
Actual Study Completion Date : December 2015



Primary Outcome Measures :
  1. embryo implantation (measured by the number of intrauterine fetal sacs on ultrasound per number of embryos transferred) after a thawing / warming cycle [ Time Frame: 6-7 weeks ]


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Ages Eligible for Study:   18 Years to 40 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
Patients with frozen thawed embryos for an ART treatment cycle
Criteria

Inclusion Criteria:

  • patients with female age < 40 years at Oocyte retrieval

Exclusion Criteria:

  • Patients with female age >40 years at Oocyte retrieval
  • cycles with Preimplantation genetic diagnosis
  • donated gametes
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Sophie Debrock, Professor Doctor PhD, KU Leuven
ClinicalTrials.gov Identifier: NCT02639715    
Other Study ID Numbers: S55685
First Posted: December 24, 2015    Key Record Dates
Last Update Posted: December 24, 2015
Last Verified: December 2015
Additional relevant MeSH terms:
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Infertility
Genital Diseases, Male
Genital Diseases, Female