Eeva™ Continued Access Study: Assessing the Usability of Eeva in a Clinical Setting

NCT01617993 | Completed

• 1 other identifier: 2012-AUX-002
• Study Type: observational
• Target: 31
• Locations: 1 country
• Sites: 3

Brief Summary

User questionnaire of Eeva System usability and reports of device malfunctions.

Conditions

Infertility

Keywords

in vitro fertilization; assisted reproduction; noninvasive imaging of embryos; time lapse imaging of embryos; traditional morphological grading of embryos; prediction of blastocysts; infertility; Genital Diseases, Male; Genital Diseases, Female

Outcome Measures

Primary Outcomes (1)

• User questionnaire of Eeva System usability and reports of device malfunctions.

  Participants will be followed through ongoing pregnancy, at approximately 10-12 weeks gestational age.

Study Arms (1)

Women undergoing IVF treatment

Women undergoing IVF treatment

Eligibility Criteria

• Age: 18 Years - 40 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

Women in the United States who undergo IVF treatment and imaging of their embryos with Eeva.

You may qualify if:

• Women undergoing fresh in vitro fertilization treatment using their own eggs or donor eggs
• Subject is ≥ 18 and ≤ 40 years of age.
• Subject has basal antral follicle count (AFC) ≥ 8 prior to stimulation cycle.
• Fertilization using only ejaculated sperm (fresh or frozen) - no surgically retrieved sperm.
• Subject has ≥ 5 normally fertilized eggs (2 PN)
• Willing to have all 2PN embryos monitored by Eeva
• Willing to comply with study protocol and procedures and able to speak English.
• Willing to provide written informed consent.

You may not qualify if:

• Reinseminated eggs.
• History of cancer.
• Gestational carriers.
• Planned preimplantation genetic diagnosis or preimplantation genetic screening.
• Previously enrolled in this study
• Concurrent participation in another clinical study.

Sponsors & Collaborators

• Progyny, Inc.: lead

Study Sites (3)

Pacific Fertility Center

San Francisco, California, 94133, United States

Location

Fertility Physicians of Northern California

San Jose, California, 95124, United States

Location

Reproductive Science Center

San Ramon, California, 94583, United States

Location

Related Links

• Auxogyn, Inc. website

MeSH Terms

Conditions

Infertility; Genital Diseases, Male; Genital Diseases, Female

Condition Hierarchy (Ancestors)

Genital Diseases; Urogenital Diseases; Male Urogenital Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications

Study Officials

• Shehua Shen, ELD, MD

  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: June 8, 2012
• First Posted: June 13, 2012
• Study Start: June 1, 2012
• Primary Completion: February 1, 2013
• Study Completion: February 1, 2013
• Last Updated: January 13, 2014

Record last verified: 2014-01

Locations

US (3)