Correlating Time-Lapse Parameters With aCGH Testing in IVF Treatment (aCGH Study)

Infertility Clinical Trial

Official title:

Correlating Time-Lapse Parameters Detected by Eeva™ With Array-Comparative Genomic Hybridization Results and Ongoing Pregnancy Rates (aCGH Study)

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT02141685
• Other study ID #: 2014-AUX-011
• Status: Active, not recruiting
• Phase: N/A
• First received: May 13, 2014
• Last updated: July 9, 2015
• Start date: May 2014
• Est. completion date: February 2016

Study information

• Verified date: July 2015
• Source: Progyny, Inc.
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Observational

Clinical Trial Summary

The purpose of this research study protocol is to collect imaging data on embryos followed to blastocyst stage (Day 5-6) and correlate Eeva parameters with array - Comparative Genomic Hybridization (aCGH) results and ongoing pregnancy rates.

Description:

The present study was designed to determine if there is a correlation between the Eeva System parameters and aCGH testing results. Embryos will be selected for transfer based on aCGH results and morphology. The Clinical site will have no access to the Eeva analysis at the time of the transfer.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 50
• Est. completion date: February 2016
• Est. primary completion date: February 2016
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 43 Years

Eligibility

Inclusion Criteria:

• Subject is =43 years of age.

• Women undergoing IVF treatment with planned aCGH testing using her own eggs or donor eggs.

• Antral Follicle Count = 6 at time of cycle start

• Baseline (day 2-3 of cycling) FSH = 15 mIU/ml

• Antimüllerian Hormone level = 0.5 ng/mL

• Fertilization using only ejaculated sperm (fresh or frozen) - no surgically retrieved sperm.

• Willing to have all 2PN embryos monitored by Eeva

• Not previously enrolled in this study.

• Willing to comply with study protocol and procedures and able to speak English.

• Willing to provide written informed consent.

Exclusion Criteria:

• BMI = 40

• Prior IVF cycle with < 4 x 2PN

• Planned Day 3 Assisted Hatching

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Infertility

Locations

Country	Name	City	State
United States	Main Line Fertility	Bryn Mawr	Pennsylvania

Sponsors (1)

Lead Sponsor	Collaborator
Progyny, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Eeva time-lapse parameters and aCGH testing results	Analysis of correlation between time-lapse parameters collected by the Eeva System and array-Comparative Genomic Hybridization (aCGH) results	5-6 days	No
Secondary	Embryo Implantation Rate	Correlation of time-lapse parameters collected by Eeva and implantation rate	6 weeks	No
Secondary	Clinical Pregnancy Rate	Correlation of time-lapse parameters collected by Eeva and clinical pregnancy rate	6 weeks	No
Secondary	Ongoing pregnancy rate	Correlation of time-lapse parameters collected by Eeva and ongoing pregnancy rate	8-12 weeks	No

External Links

•   Link