Modulation Contrast Microscopy Imaging for Oocyte Quality Assessment

Oocyte Competence Clinical Trial

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT03683290
• Other study ID #: oocyte_imaging_2018
• Status: Active, not recruiting
• Start date: January 1, 2019
• Est. completion date: January 1, 2022

Study information

• Verified date: September 2020
• Source: Center for Reproductive an Genetic Health
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical 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. 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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 200
• Est. completion date: January 1, 2022
• Est. primary completion date: August 10, 2020
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 50 Years

Eligibility

Inclusion Criteria:

• Intracytoplasmic sperm injection

• Embryo culture with subsequent fresh embryo transfer

Exclusion Criteria:

• Conventional IVF

Related Conditions & MeSH terms

• Oocyte Competence

Intervention

Other:
• Image acquisition and analysis
Oocyte image obtention and analysis prior to intracytoplasmic sperm injection

Locations

Country	Name	City	State
United Kingdom	Centre for Reproductive and Genetics Health	London

Sponsors (2)

Lead Sponsor	Collaborator
Center for Reproductive an Genetic Health	University College, London

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Implantation	Number of gestational sacs seen on ultrasound scan	6 weeks gestation
Secondary	Live Birth	Baby to be born after embryo transfer	40 weeks gestation
Secondary	Fertilisation	Appearance of two pronucleii after insemination	17 ± 1 hours post insemination
Secondary	Embryo quality clevage	Quality after three days of culture	68 ± 1 hours post insemination
Secondary	Embryo quality Blastocyst	Quality at the blastocyst stage	116 ±2 hours post insemination
Secondary	Euploidy	Number of chromosomes (if available, after PGT-A)	2-3 weeks post insemination
Secondary	Nuclear maturity	Presence of meiotic spindle (if available, PolScope)	36-41 post hCG