NCT02639715

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.

Trial Health

100
On Track

Trial Health Score

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

Enrollment
1,272

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jan 2014

Status
completed

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

January 1, 2014

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2014

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2015

Completed
14 days until next milestone

First Submitted

Initial submission to the registry

December 15, 2015

Completed
9 days until next milestone

First Posted

Study publicly available on registry

December 24, 2015

Completed
Last Updated

December 24, 2015

Status Verified

December 1, 2015

Enrollment Period

11 months

First QC Date

December 15, 2015

Last Update Submit

December 22, 2015

Conditions

Outcome Measures

Primary Outcomes (1)

  • embryo implantation (measured by the number of intrauterine fetal sacs on ultrasound per number of embryos transferred) after a thawing / warming cycle

    6-7 weeks

Eligibility Criteria

Age18 Years - 40 Years
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64)
Sampling MethodNon-Probability Sample
Study Population

Patients with frozen thawed embryos for an ART treatment cycle

You may qualify if:

  • patients with female age \< 40 years at Oocyte retrieval

You may not qualify if:

  • Patients with female age \>40 years at Oocyte retrieval
  • cycles with Preimplantation genetic diagnosis
  • donated gametes

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (2)

  • Fernandez Gallardo E, Spiessens C, D'Hooghe T, Debrock S. Effect of day 3 embryo morphometrics and morphokinetics on survival and implantation after slow freezing-thawing and after vitrification-warming: a retrospective cohort study. Reprod Biol Endocrinol. 2017 Oct 3;15(1):79. doi: 10.1186/s12958-017-0299-5.

  • Fernandez Gallardo E, Spiessens C, D'Hooghe T, Debrock S. Effect of embryo morphology and morphometrics on implantation of vitrified day 3 embryos after warming: a retrospective cohort study. Reprod Biol Endocrinol. 2016 Jul 30;14(1):40. doi: 10.1186/s12958-016-0175-8.

MeSH Terms

Conditions

Infertility

Condition Hierarchy (Ancestors)

Genital DiseasesUrogenital Diseases

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Professor Doctor PhD

Study Record Dates

First Submitted

December 15, 2015

First Posted

December 24, 2015

Study Start

January 1, 2014

Primary Completion

December 1, 2014

Study Completion

December 1, 2015

Last Updated

December 24, 2015

Record last verified: 2015-12