Correlating Time-Lapse Parameters Detected by the Eeva™ System With Comprehensive Chromosome Screening Results

NCT01635049 | Completed

• 1 other identifier: 2012-AUX-004
• Study Type: observational
• Target: 110
• Locations: 1 country
• Sites: 2

Brief 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 System parameters with comprehensive chromosome screening (CCS) results, implantation and live birth.

Conditions

Infertility

Keywords

in vitro fertilization; assisted reproduction techniques; noninvasive imaging of embryos; time lapse imaging of embryos; traditional morphological grading of embryos; prediction of blastocysts; infertility; preimplantation genetic diagnosis; comprehensive chromosome screening

Outcome Measures

Primary Outcomes (1)

• Eeva time-lapse parameters and CCS

  Analyse the correlation of time-lapse parameters collected by the Eeva System and comprehensive chromosome screening (CCS) results.

  5-6 days

Secondary Outcomes (6)

• Correlation of time-lapse parameters collected by the Eeva System and implantation rate.

  6 weeks

• Correlation of time-lapse parameters collected by the Eeva System and clinical pregnancy rate

  6 weeks

• Correlation of time-lapse parameters collected by the Eeva System and ongoing pregnancy rate

  7 - 8 weeks

• Correlation of time-lapse parameters collected by the Eeva System and delivery rate

  live birth

• Correlation of time-lapse parameters collected by the Eeva System and spontaneous miscarriage rate

  live birth

Study Arms (1)

Women undergoing IVF treatment and CCS

•Women undergoing fresh IVF treatment and undergoing CCS, as recommended based on medical need by the clinical site reproductive endocrinologist.

Eligibility Criteria

• Age: Up to 43 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

Women undergoing fresh IVF treatment and undergoing CCS, as recommended based on medical need by the clinical site reproductive endocrinologist.

You may qualify if:

• Subject is ≤43 years of age.
• Women undergoing fresh IVF treatment using her own eggs or donor eggs and undergoing CCS, as recommended based on medical need by the clinical site reproductive endocrinologist.
• 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.
• No concurrent participation in another clinical study.
• Willing to comply with study protocol and procedures and able to speak English.
• Willing to provide written informed consent.

You may not qualify if:

• BMI ≥ 40
• Prior IVF cycle with \< 4 x 2PN
• Diminished ovarian reserve as demonstrated by any one of the following:
• BAFC \< 6 at time of cycle start
• Maximum prior FSH \> 15
• AMH \< 0.5

Sponsors & Collaborators

• Progyny, Inc.: lead

Study Sites (2)

Reproductive Medicine Associates of New Jersey

Morristown, New Jersey, 07960, United States

Location

Reproductive Medicine Associates of New York

New York, New York, 10022, United States

Location

Related Links

• Auxogyn, Inc. website

MeSH Terms

Conditions

Infertility

Condition Hierarchy (Ancestors)

Genital Diseases; Urogenital Diseases

Study Officials

• Richard T Scott, Jr., MD

  Reproductive Medicine Associates of New Jersey

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 2, 2012
• First Posted: July 6, 2012
• Study Start: June 1, 2012
• Primary Completion: December 1, 2014
• Study Completion: December 1, 2014
• Last Updated: January 14, 2015

Record last verified: 2015-01

Locations

US (2)