Infertility Clinical Trial
— CASOfficial title:
Eeva Continued Access Study.
Verified date | January 2014 |
Source | Progyny, Inc. |
Contact | n/a |
Is FDA regulated | No |
Health authority | United States: Institutional Review Board |
Study type | Observational |
User questionnaire of Eeva System usability and reports of device malfunctions.
Status | Completed |
Enrollment | 31 |
Est. completion date | February 2013 |
Est. primary completion date | February 2013 |
Accepts healthy volunteers | No |
Gender | Female |
Age group | 18 Years to 40 Years |
Eligibility |
Inclusion Criteria: - 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. Exclusion Criteria: - 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. |
Observational Model: Cohort, Time Perspective: Prospective
Country | Name | City | State |
---|---|---|---|
United States | Pacific Fertility Center | San Francisco | California |
United States | Fertility Physicians of Northern California | San Jose | California |
United States | Reproductive Science Center | San Ramon | California |
Lead Sponsor | Collaborator |
---|---|
Progyny, Inc. |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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. | No |
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