NCT03683290

Brief Summary

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.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
200

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jan 2019

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 18, 2018

Completed
7 days until next milestone

First Posted

Study publicly available on registry

September 25, 2018

Completed
3 months until next milestone

Study Start

First participant enrolled

January 1, 2019

Completed
1.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 10, 2020

Completed
1.4 years until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2022

Completed
Last Updated

September 9, 2020

Status Verified

September 1, 2020

Enrollment Period

1.6 years

First QC Date

September 18, 2018

Last Update Submit

September 7, 2020

Conditions

Oocyte Competence

Keywords

OocyteEmbryoDevelopmentPregnancyCompetence

Outcome Measures

Primary Outcomes (1)

  • Implantation

    Number of gestational sacs seen on ultrasound scan

    6 weeks gestation

Secondary Outcomes (6)

  • Live Birth

    40 weeks gestation

  • Fertilisation

    17 ± 1 hours post insemination

  • Embryo quality clevage

    68 ± 1 hours post insemination

  • Embryo quality Blastocyst

    116 ±2 hours post insemination

  • Euploidy

    2-3 weeks post insemination

  • +1 more secondary outcomes

Interventions

Image acquisition and analysisOTHER

Oocyte image obtention and analysis prior to intracytoplasmic sperm injection

Eligibility Criteria

Age18 Years - 50 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)
Sampling MethodProbability Sample
Study Population

Registered patients at The Centre for Reproductive and Genetic Health

You may qualify if:

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

You may not qualify if:

  • \- Conventional IVF

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Centre for Reproductive and Genetics Health

London, W1W 5QS, United Kingdom

Location

Study Officials

  • Sioban SenGupta

    Institute for Women's Health (UCL)

    STUDY CHAIR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Target Duration
40 Weeks
Sponsor Type
INDUSTRY
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal investigator

Study Record Dates

First Submitted

September 18, 2018

First Posted

September 25, 2018

Study Start

January 1, 2019

Primary Completion

August 10, 2020

Study Completion

January 1, 2022

Last Updated

September 9, 2020

Record last verified: 2020-09

Data Sharing

IPD Sharing
Will not share

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

Locations

GB(1)