Pivotal Observational CHLOE Study

IVF Clinical Trial

Official title:

A Pivotal, Observational, Prospective Assessment Study to Assess the Performance of Fairtility CHLOE BLAST™ Algorithm for the Prediction of Blastocyst Formation in Women Undergoing In-vitro Fertilization

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06111365
• Other study ID #: FRT-02-22
• Status: Recruiting
• Start date: January 22, 2024
• Est. completion date: June 2024

Study information

• Verified date: March 2024
• Source: Fairtility
• Contact: Maya Baranes
• Phone: 972-524697725
• Email: maya.baranes[@]fairtility.com
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial Summary

This pivotal study is an observational, prospective assessment, multi-center, databank based, clinical study aimed to evaluate the performance of CHLOE™ algorithm in prediction of blastocyst formation. Day 3 morphological grading will be performed by three clinical embryologists (hereafter "Assessors"), who will use standard embryo grading assessment techniques and will be blinded to the CHLOE™ information and to the actual blastocyte status (Yes/No). Five independent embryologists (hereafter "Panelists") who will be masked to imaging data, to actual blastocyst status, and to each other evaluations will be provided with the morphological grading information performed earlier by the 3 assessors and with the age of subject or egg donor. All data will be presented to Panelists as full cohorts of embryos for each mother. Then they will provide their prediction on blastocyst status of each embryo twice: once the prediction will be based on morphology only and once on morphology plus CHLOE™ assigned score ("High", "Medium+", "Medium-", or "Low"). The two assessments will be done with a washout period of at least 2 weeks and no information will be provided to link the two assessments.

Description:

This pivotal study is an observational, prospective assessment, multi-center, databank based, clinical study aimed to evaluate the performance of CHLOE™ algorithm in prediction of blastocyst formation. Day 3 morphological grading will be performed by three clinical embryologists (hereafter "Assessors"), who will use standard embryo grading assessment techniques and will be blinded to the CHLOE™ information and to the actual blastocyte status (Yes/No). Five independent embryologists (hereafter "Panelists") who will be masked to imaging data, to actual blastocyst status, and to each other evaluations will be provided with the morphological grading information performed earlier by the 3 assessors and with the age of subject or egg donor. All data will be presented to Panelists as full cohorts of embryos for each mother. Then they will provide their prediction on blastocyst status of each embryo twice: once the prediction will be based on morphology only and once on morphology plus CHLOE™ assigned score ("High", "Medium+", "Medium-", or "Low"). The two assessments will be done with a washout period of at least 2 weeks and no information will be provided to link the two assessments.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 55
• Est. completion date: June 2024
• Est. primary completion date: May 2024
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 120 Years

Eligibility

Inclusion Criteria:

1. Women undergoing fresh IVF treatment using their own eggs or donor eggs.

2. Women at least 18 years of age; in case of a donor egg the donor shall be at least 18.

3. Total antral follicle count (AFC) of at least 12 as measured by ultrasound prior to stimulation (in cases where AFC is performed).

4. Basal follicle-stimulating hormone (FSH) level < 10 IU or AMH > 1.2 ng/ml

5. At least 8 normally fertilized eggs at bipronuclear (2PN) stage in this in-vitro fertilization cycle.

Inclusion criteria related to the embryos:

6. Fertilization using only ejaculated sperm (fresh or frozen) - no surgically removed sperm.

7. At least 2 cells embryo.

8. Embryos were cultured in a Embryoscope ES-D (i.e., EmbryoScope model D - 6 spaces for patients, 12 wells each, resolution - 500*500). The EmbryoScope was configured to the default values provided by EmbryoScope manufacturer. Exclusion Criteria:

Exclusion criteria related to the biological mother (or egg donor):

1. Gestational carriers

2. Concurrent participation in another clinical study

3. Previous enrollment in this clinical study (i.e., previous cycles of the same women)

4. History of cancer

Exclusion criteria related to the embryos:

5. Use of re-inseminated eggs

6. Embryos that underwent day 3 biopsy for preimplantation genetic testing (PGT)

7. Embryos that underwent biopsy at cleavage stage

8. Non-2PN embryos

9. Embryos with video frames in which the embryo is not clearly visible. Namely, videos with empty well, Bad Focus, Cropped Embryo, Air Bubble (see Annotation protocol, embryos with "Technical Errors" states)

Related Conditions & MeSH terms

• IVF

Intervention

Device:
• CHLOE
the system will provide to the user a "CHLOE™ score", which is a blastocyst development prediction value, a discrete grading for blastocyst associated with the likelihood of the embryo reaching the blastocyst stage at Day 5

Locations

Country	Name	City	State
United States	Cleveland Clinic Fertility	Cleveland	Ohio
United States	Dallas Fertility Center	Dallas	Texas
United States	Weill Cornell Medicine	New York	New York

Sponsors (1)

Lead Sponsor	Collaborator
Fairtility

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	embryo blastocyst prediction	High Medium+ Medium- Low	day 5