NCT04901247

Brief Summary

While numerous types of commercially available human embryo culture media exist for human blastocyst culture, the impact of culture conditions on blastocyst development and aneuploidy formation is not fully understood. Culture conditions are very important for the success of the in vitro fertilization (IVF) cycle, many of the factors involved in the process have been extensively studied. However, none of the studies investigated the effect on euploid rate in a sibling oocyte design with preimplantation genetic testing for aneuploidy (PGT-A), which requires culture till day 7. In addition, the clinical outcome (implantation) will be investigated in a frozen cycle regimen. Hence, the study will explore which day of media refreshment will result in higher rate of ploidy and would improve clinical outcomes. Investigators aim at exploring the best practice, that would empower the euploid rate through the comparison of refreshing the single-step medium on day 3 or day 5 in a sibling oocyte prospective design.

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
50

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Jul 2021

Typical duration for all trials

Geographic Reach
1 country

2 active sites

Status
unknown

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

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

May 20, 2021

Completed
5 days until next milestone

First Posted

Study publicly available on registry

May 25, 2021

Completed
1 month until next milestone

Study Start

First participant enrolled

July 6, 2021

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 30, 2023

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 30, 2023

Completed
Last Updated

March 24, 2023

Status Verified

March 1, 2023

Enrollment Period

2 years

First QC Date

May 20, 2021

Last Update Submit

March 23, 2023

Conditions

AneuploidyInfertility

Keywords

infertilityivfembryoembryoscopeculture mediaaneuploidy

Outcome Measures

Primary Outcomes (1)

  • blastocyst ploidy

    determined after biopsy of trophectoderm cells, taken from the blastocyst on day 5, 6 or 7 from development.

    3 days

Secondary Outcomes (4)

  • cycle ploidy rate

    1 day

  • mosaicism frequency

    1 day

  • blastocyst quality at time of biopsy

    1 day

  • blastulation rate

    5 days

Study Arms (2)

day 3

embryo grading and culture refreshment will be done 67-69 hours post insemination

Behavioral: media refreshmentBehavioral: embryo grading

day 5

embryo grading and culture medium refreshment will be done 114-118 hours post insemination

Behavioral: media refreshmentBehavioral: embryo grading

Interventions

media refreshmentBEHAVIORAL

20µL of culture medium is aspirated using Eppendorf PCR tips, and freshly, overnight equilibrated 20µL global total LP will be added to the same well

day 3day 5
embryo gradingBEHAVIORAL

embryo grading should be done prior to media refreshment

day 3day 5

Eligibility Criteria

Age18 Years - 40 Years
Sexfemale(Gender-based eligibility)
Age GroupsAdult (18-64)
Sampling MethodNon-Probability Sample
Study Population

Patients undergoing a fertility treatment due to primary or secondary infertility at ART Fertility Clinics.

You may qualify if:

  • Patients with a minimum of 8 - 10 follicles during ovarian stimulation
  • Patients with a minimum of 8 mature oocytes
  • PGT-A
  • ICSI
  • BMI\<35
  • Age 18- 40
  • Fresh or frozen ejaculatory sperm \>10,000 motile sperm
  • Any Ovarian stimulation
  • Embryos cultured in Time-lapse system

You may not qualify if:

  • PGT-M or PGT-SR
  • Previous history of embryo arrest
  • Endometriosis
  • Hydrosalpinx
  • History of uterine abnormality or previous uterine surgery
  • History of previous treatment which may impact the ovarian reserve (adnexal surgery, chemotherapy, radiation…)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

ART Fertility Clinics

Abu Dhabi, United Arab Emirates

Location

Ibrahim Elkhatib

Abu Dhabi, United Arab Emirates

Location

Related Publications (3)

  • Bavister BD, Poole KA. Duration and temperature of culture medium equilibration affect frequency of blastocyst development. Reprod Biomed Online. 2005 Jan;10(1):124-9. doi: 10.1016/s1472-6483(10)60813-9.

    PMID: 15705308BACKGROUND

  • Costa-Borges N, Belles M, Meseguer M, Galliano D, Ballesteros A, Calderon G. Blastocyst development in single medium with or without renewal on day 3: a prospective cohort study on sibling donor oocytes in a time-lapse incubator. Fertil Steril. 2016 Mar;105(3):707-713. doi: 10.1016/j.fertnstert.2015.11.038. Epub 2015 Dec 12.

    PMID: 26690010BACKGROUND

  • Krasnopolskaya KV, Beketova AN, Sesina NI, capital ES, Cyrillichinchenko NK, Badalyan GV, Sudarikova NM, Bocharova TV, Zakharchenko EO. The effect of short-term disturbance of day 3 embryo culture on the development and implantation. Gynecol Endocrinol. 2019;35(sup1):1-4. doi: 10.1080/09513590.2019.1632083.

    PMID: 31532309BACKGROUND

MeSH Terms

Conditions

AneuploidyInfertilityLong Qt Syndrome 3

Condition Hierarchy (Ancestors)

Chromosome AberrationsPathologic ProcessesPathological Conditions, Signs and SymptomsGenital DiseasesUrogenital Diseases

Study Officials

  • IBRAHIM ELKHATIB

    ART Fertility Clinics LLC

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Target Duration
7 Days
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

May 20, 2021

First Posted

May 25, 2021

Study Start

July 6, 2021

Primary Completion

June 30, 2023

Study Completion

December 30, 2023

Last Updated

March 24, 2023

Record last verified: 2023-03

Locations

AE(2)