Oocyte CompetenceNCT03683290
Modulation Contrast Microscopy Imaging for Oocyte Quality Assessment
An observational study of Oocyte Competence, run by Center for Reproductive an Genetic Health at 1 site in United Kingdom.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 50 yearsHealthy volunteers can take part
- Conditions the study is for
- Oocyte Competence
- What is being tested?
- Image acquisition and analysis
- Type of treatment
- Injection or infusion
- How many people
- 200 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 1 Jan 2019to 1 Jan 2022
- How long will I take part?
- 40 Weeks
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 50 years
- All sexes
- Healthy volunteers accepted
- Adult
Study population: Registered patients at The Centre for Reproductive and Genetic Health
Who may be able to join
- Intracytoplasmic sperm injection
- Embryo culture with subsequent fresh embryo transfer
Who cannot join
- Conventional IVF
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
Centre for Reproductive and Genetics Health
London, W1W 5QS
About this study
Official title: 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.
- Conditions
- Oocyte Competence
- Being tested
- Image acquisition and analysis
- Keywords
- Oocyte, Embryo, Development, Pregnancy, Competence
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Image acquisition and analysisOther
Oocyte image obtention and analysis prior to intracytoplasmic sperm injection
What is being measured
The primary outcome is the main question the study is designed to answer.
Implantation
Number of gestational sacs seen on ultrasound scan
Measured: 6 weeks gestation
Secondary outcomes (6)
Live Birth
Baby to be born after embryo transfer
Measured: 40 weeks gestation
Fertilisation
Appearance of two pronucleii after insemination
Measured: 17 ± 1 hours post insemination
Embryo quality clevage
Quality after three days of culture
Measured: 68 ± 1 hours post insemination
Embryo quality Blastocyst
Quality at the blastocyst stage
Measured: 116 ±2 hours post insemination
Euploidy
Number of chromosomes (if available, after PGT-A)
Measured: 2-3 weeks post insemination
Nuclear maturity
Presence of meiotic spindle (if available, PolScope)
Measured: 36-41 post hCG
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Sep 2018
- Study start1 Jan 2019
- Primary completion10 Aug 2020
- Study completion1 Jan 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Oocyte CompetenceStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 200 participants (estimated)
- Target duration
- 40 Weeks
Sponsor and investigators
- Lead sponsor
- Center for Reproductive an Genetic Health
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- University College, London
- Responsible party
- Principal investigator, Xavier Vinals Gonzalez, Center for Reproductive an Genetic Health
- Investigators
- Sioban SenGupta, Study chair, Institute for Women's Health (UCL)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03683290
- Sponsor's protocol ID
- oocyte_imaging_2018
- Status last verified
- Sep 2020
- First submitted
- 18 Sep 2018
- Last updated
- 9 Sep 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Data will be collected and analysed internally. Results will be available (if published) in a scientific journal.
Study at a glance
From the registry record, last updated by the sponsor on 9 Sep 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficiency of Modulation Contrast Microscopy Image Analysis as a Predictive Tool for Human Oocyte Quality
- ClinicalTrials.gov ID
- NCT03683290
- Acronym / sponsor ID
- oocyte_imaging_2018
- Conditions
- Oocyte Competence
- Keywords
- Oocyte, Embryo, Development, Pregnancy, Competence
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Center for Reproductive an Genetic HealthIndustry (pharma, biotech, devices)
- Collaborators
- University College, London
- Study start
- 1 Jan 2019 (actual)
- Primary completion
- 10 Aug 2020 (actual)
- Study completion
- 1 Jan 2022 (estimated)
- First posted
- 25 Sep 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 40 Weeks
Who may qualify
- Ages
- 18 to 50 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- Registered patients at The Centre for Reproductive and Genetic Health
Key inclusion criteria (2 listed)
- Intracytoplasmic sperm injection
- Embryo culture with subsequent fresh embryo transfer
Key exclusion criteria (1 listed)
- Conventional IVF
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Image acquisition and analysisOocyte image obtention and analysis prior to intracytoplasmic sperm injection | Other | – |
Primary outcome
Implantation
Time frame: 6 weeks gestation
Number of gestational sacs seen on ultrasound scan
6 secondary outcomes
Live Birth
Time frame: 40 weeks gestation
Fertilisation
Time frame: 17 ± 1 hours post insemination
Embryo quality clevage
Time frame: 68 ± 1 hours post insemination
Embryo quality Blastocyst
Time frame: 116 ±2 hours post insemination
Euploidy
Time frame: 2-3 weeks post insemination
Nuclear maturity
Time frame: 36-41 post hCG
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Sep 2020.
- Individual participant dataSharing planned: No. Data will be collected and analysed internally. Results will be available (if published) in a scientific journal.
Related trials for Oocyte Competence
Recruiting
The EPIC Study: Exploring Paternal Age and the Influence on Blastocyst Culture
Infertility (IVF Patients), Oocyte Competence
Recruiting
Adipose Stem Cell Mitochondria Supplementation to Oocytes (ASCENT)
Female Infertility, Oocyte Competence
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Sioban SenGupta study chair
Institute for Women's Health (UCL)
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Oocyte Competence, run by Center for Reproductive an Genetic Health at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 9 Sep 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Implantation (time frame: 6 weeks gestation). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Sep 2020.