InfertilityNCT02141685
Correlating Time-Lapse Parameters With aCGH Testing in IVF Treatment (aCGH Study)
An observational study of Infertility, run by Progyny, Inc. at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 18 to 43 years, women only
- Conditions the study is for
- Infertility
- How many people
- 50 participants
- Where
- 1 siteUnited States
- Study dates
- May 2014to Feb 2016
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 43 years
- Women only
- No healthy volunteers
- Adult
Study population: Women undergoing fresh IVF treatment and undergoing aCGH testing, as recommended based on medical need by the clinical site reproductive endocrinologist.
Who may be able to join
- 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.
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- 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.
Who cannot join
- BMI ≥ 40
- Prior IVF cycle with < 4 x 2PN
- Planned Day 3 Assisted Hatching
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Correlating Time-Lapse Parameters Detected by Eeva™ With Array-Comparative Genomic Hybridization Results and Ongoing Pregnancy Rates (aCGH Study)
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.
Read the detailed 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.
- 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
- Medical subject headings
- Infertility
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 5-6 days
Secondary outcomes (3)
Embryo Implantation Rate
Correlation of time-lapse parameters collected by Eeva and implantation rate
Measured: 6 weeks
Clinical Pregnancy Rate
Correlation of time-lapse parameters collected by Eeva and clinical pregnancy rate
Measured: 6 weeks
Ongoing pregnancy rate
Correlation of time-lapse parameters collected by Eeva and ongoing pregnancy rate
Measured: 8-12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 May 2014 (estimated)
- Study startMay 2014
- Primary completionFeb 2016 (estimated)
- Study completionFeb 2016 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for InfertilityStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Progyny, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Shehua Shen, MD, ELD, Study director, Progyny, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02141685
- Sponsor's protocol ID
- 2014-AUX-011
- Status last verified
- Jul 2015
- First submitted
- 13 May 2014
- Last updated
- 13 Jul 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Jul 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Correlating Time-Lapse Parameters Detected by Eeva™ With Array-Comparative Genomic Hybridization Results and Ongoing Pregnancy Rates (aCGH Study)
- ClinicalTrials.gov ID
- NCT02141685
- Acronym / sponsor ID
- 2014-AUX-011
- 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
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Progyny, Inc.Industry (pharma, biotech, devices)
- Study start
- May 2014
- Primary completion
- Feb 2016 (estimated)
- Study completion
- Feb 2016 (estimated)
- First posted
- 19 May 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed 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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 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. |
Who may qualify
- Ages
- 18 to 43 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
- Study population
- Women undergoing fresh IVF treatment and undergoing aCGH testing, as recommended based on medical need by the clinical site reproductive endocrinologist.
Key inclusion criteria (10 listed)
- 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
Key exclusion criteria (3 listed)
- BMI ≥ 40
- Prior IVF cycle with < 4 x 2PN
- Planned Day 3 Assisted Hatching
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Eeva time-lapse parameters and aCGH testing results
Time frame: 5-6 days
Analysis of correlation between time-lapse parameters collected by the Eeva System and array-Comparative Genomic Hybridization (aCGH) results
3 secondary outcomes
Embryo Implantation Rate
Time frame: 6 weeks
Clinical Pregnancy Rate
Time frame: 6 weeks
Ongoing pregnancy rate
Time frame: 8-12 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Jul 2015.
- Related InfoLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Shehua Shen, MD, ELD study director
Progyny, Inc.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Infertility, run by Progyny, Inc. at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 13 Jul 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Eeva time-lapse parameters and aCGH testing results (time frame: 5-6 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Jul 2015.