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

NCT02141685 | Unknown

• 1 other identifier: 2014-AUX-011
• Study Type: observational
• Target: 50
• Locations: 1 country
• Sites: 1

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 parameters with array - Comparative Genomic Hybridization (aCGH) results and ongoing pregnancy rates.

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; array-Comparative Genomic Hybridization

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (3)

• Embryo Implantation Rate

  6 weeks

• Clinical Pregnancy Rate

  6 weeks

• Ongoing pregnancy rate

  8-12 weeks

Study Arms (1)

IVF patients undergoing aCGH Testing

Women undergoing fresh IVF treatment and array-comparative genomic hybridization testing (aCGH), as recommended based on medical need by the clinical site reproductive endocrinologist.

Eligibility Criteria

• Age: 18 Years - 43 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

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

You may qualify if:

• 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.

You may not qualify if:

• BMI ≥ 40
• Prior IVF cycle with \< 4 x 2PN
• Planned Day 3 Assisted Hatching

Sponsors & Collaborators

• Progyny, Inc.: lead

Study Sites (1)

Main Line Fertility

Bryn Mawr, Pennsylvania, 19010, United States

Location

Related Links

• Related Info

MeSH Terms

Conditions

Infertility

Condition Hierarchy (Ancestors)

Genital Diseases; Urogenital Diseases

Study Officials

• Shehua Shen, MD, ELD

  Progyny, Inc.

  STUDY DIRECTOR

Study Design

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

Study Record Dates

• First Submitted: May 13, 2014
• First Posted: May 19, 2014
• Study Start: May 1, 2014
• Primary Completion: February 1, 2016
• Study Completion: February 1, 2016
• Last Updated: July 13, 2015

Record last verified: 2015-07

Locations

US (1)