Modulation Contrast Microscopy Imaging for Oocyte Quality Assessment

September 7, 2020 updated by: Xavier Vinals Gonzalez, Center for Reproductive an Genetic Health

Efficiency of Modulation Contrast Microscopy Image Analysis as a Predictive Tool for Human Oocyte Quality

The present study aims to describe novel non-invasive parameters related to the competence of female reproductive cells (oocytes). In a fertility unit, human reproductive cells and embryos are subjected to different imaging technologies. Images can easily be obtained without disturbing the microenvironment during different standard procedures. Turning images into quantifiable data might provide a further understanding on oocyte behavior and performance in the laboratory.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Anticipated)

200

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

  • United Kingdom
      • London, United Kingdom, W1W 5QS
        • Centre for Reproductive and Genetics Health

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

18 years to 50 years (Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

Registered patients at The Centre for Reproductive and Genetic Health

Description

Inclusion Criteria:

  • Intracytoplasmic sperm injection
  • Embryo culture with subsequent fresh embryo transfer

Exclusion Criteria:

- Conventional IVF

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Implantation
Time Frame: 6 weeks gestation
Number of gestational sacs seen on ultrasound scan
6 weeks gestation

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Live Birth
Time Frame: 40 weeks gestation
Baby to be born after embryo transfer
40 weeks gestation
Fertilisation
Time Frame: 17 ± 1 hours post insemination
Appearance of two pronucleii after insemination
17 ± 1 hours post insemination
Embryo quality clevage
Time Frame: 68 ± 1 hours post insemination
Quality after three days of culture
68 ± 1 hours post insemination
Embryo quality Blastocyst
Time Frame: 116 ±2 hours post insemination
Quality at the blastocyst stage
116 ±2 hours post insemination
Euploidy
Time Frame: 2-3 weeks post insemination
Number of chromosomes (if available, after PGT-A)
2-3 weeks post insemination
Nuclear maturity
Time Frame: 36-41 post hCG
Presence of meiotic spindle (if available, PolScope)
36-41 post hCG

Collaborators and Investigators

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

Sponsor

Center for Reproductive an Genetic Health

Collaborators

University College, London

Investigators

  • Study Chair: Sioban SenGupta, Institute for Women's Health (UCL)

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 (Actual)

January 1, 2019

Primary Completion (Actual)

August 10, 2020

Study Completion (Anticipated)

January 1, 2022

Study Registration Dates

First Submitted

September 18, 2018

First Submitted That Met QC Criteria

September 21, 2018

First Posted (Actual)

September 25, 2018

Study Record Updates

Last Update Posted (Actual)

September 9, 2020

Last Update Submitted That Met QC Criteria

September 7, 2020

Last Verified

September 1, 2020

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • oocyte_imaging_2018

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

Data will be collected and analysed internally. Results will be available (if published) in a scientific journal.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

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.

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