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A Benchtop Incubator Prospective Study

NCT04969575 · Status: UNKNOWN · Type: OBSERVATIONAL · Enrollment: 50

Last updated 2023-03-24

No results posted yet for this study

Summary

The use of extended embryo culture to the blastocyst stage and preimplantation genetic testing for aneuploidy (PGT-A) has enabled identification and selection of embryos with the best developmental potential and improved in vitro fertilization (IVF) clinical outcomes. While numerous types of commercially available human embryo culture media exist for culture to the blastocyst stage, the impact of culture conditions on blastocyst development and aneuploidy formation is not well understood.

Culture conditions are very important for the success of the IVF cycle, many of the factors involved in the process have been extensively studied, including the use of sequential culture medium vs single step culture medium, humidified incubators vs dry incubators and refreshing the medium on day 3 vs uninterrupted culture till day 5. However, none of the studies investigated the effect on euploid rate in a sibling oocyte design with PGT-A, which requires culture till day 7.

Conditions

Interventions

OTHER

Insemination and culture

All MII oocytes will be inseminated by ICSI 39-41 hours post final oocyte maturation trigger.

OTHER

Media refreshment Group 1

Zygote scoring on day 1 (18-20hpi). Culture medium refreshment will be done 67-69 hours post insemination (Day3).

OTHER

Culture media preparation and refreshment

30µL of culture medium (Global total LP is added to each well of the 8 wells of LifeGlobal GPS Dish (EGPS-010) and 50µL to the center 3 drops. Dishes will be equilibrated overnight in a CO2 incubator.

OTHER

Embryo grading

Should be done prior to media refreshment. For group 2, embryo grading and media refreshment is done prior to blastocyst biopsy.

OTHER

Media refreshment Group 2

Zygote scoring on day 1 (18-20hpi). Culture media refreshment will be done 114-118 hours post insemination (Day5).

Sponsors & Collaborators

  • ART Fertility Clinics LLC

    lead OTHER

Principal Investigators

  • IBRAHIM ELKHATIB · ART Fertility Clinics LLC

Eligibility

Min Age
18 Years
Max Age
40 Years
Sex
FEMALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2021-07-15
Primary Completion
2023-06-30
Completion
2023-12-31

Countries

  • United Arab Emirates

Study Locations

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04969575 on ClinicalTrials.gov