InfertilityMERGENCT01816802
Registry Study of Traditional Morphology Grading Combined With Eeva in IVF Treatment
An observational study of Infertility, run by Progyny, Inc. at 12 sites in United States.
Trial summary
The purpose of this study is to record and evaluate the use of traditional morphology grading combined with Eeva in the treatment of in vitro fertilization. Read more about this study
- Who is it for?
- Any age, women only
- Conditions the study is for
- Infertility
- What is being tested?
- In-vitro fertilization using Eeva
- Type of treatment
- Medical device
- How many people
- 1,200 participants
- Where
- 12 sitesUnited States
- Study dates
- Feb 2013to Jun 2015
- How long will I take part?
- 12 Months
- 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 Any age
- Women only
- No healthy volunteers
- Child, Adult, Older adult
Study population: Patients undergoing in vitro fertilization treatment who provide informed consent and use Eeva in their treatment cycle.
Who may be able to join
- women undergoing fresh in vitro fertilization treatment using their own eggs or donor eggs.
Who cannot join
- history of cancer.
- gestational carrier.
Trial locations and contacts
12 sites in 1 country.
12 sites in 1 country
United States12 sites
University Hospital Fertility Center
Beachwood, Ohio, 44122
Fertility Centers of Illinois - River North
Chicago, Illinois, 60610
Northwestern Medical Faculty Foundation
Chicago, Illinois, 60611
Institute for Reproductive Health
Cincinnati, Ohio, 45209
HRC Fertility
Encino, California, 91436
Center for Advanced Reproductive Services (UCHC)
Farmington, Connecticut, 06030
Fertility Centers of Illinois, Highland Park IVF Center
Highland Park, Illinois, 60035
Long Island IVF
Melville, New York, 11747
Stanford Fertility and Reproductive Medicine Center
Palo Alto, California, 94304
Reproductive Partners
Redondo Beach, California, 90277
Fertility Center of San Antonio
San Antonio, Texas, 78229
Pacific Fertility Center
San Francisco, California, 95124
About this study
Official title: MERGE: MulticEnter ReGistry With Eeva
The purpose of this study is to record and evaluate the use of traditional morphology grading combined with Eeva in the treatment of in vitro fertilization.
Read the detailed description
This is a prospective, observational, single-arm, nonrandomized, multicenter study. Data will be collected to establish eligibility, at baseline, during the stimulation and in vitro fertilization process, during embryo culture, at embryo transfer, at 12-18 days post egg retrieval to verify biochemical pregnancy, and then typically at 5-6 weeks gestational weeks to verify clinical pregnancy.
- Conditions
- Infertility
- Being tested
- In-vitro fertilization using Eeva
- Keywords
- In vitro fertilization, Assisted reproductive therapy, Time-lapse image recording, Image analysis software
- Medical subject headings
- Infertility
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
In-vitro fertilization using EevaDevice
Eeva will image embryos through cleavage stage (Day 3). Embryologists will use Eeva results along with traditional morphological grading to assist in selecting embryo(s) for transfer or freezing.
| Study group | Role | What they receive |
|---|---|---|
| In-vitro fertilization using Eeva | Patients undergoing in-vitro fertilization treatment who provide informed consent and use Eeva in their treatment cycle. Receives: Device: In-vitro fertilization using Eeva |
What is being measured
The primary outcome is the main question the study is designed to answer.
Clinical Pregnancy Rate
Determined by first pregnancy ultrasound outcome and optional 12-month phone follow-up
Measured: 5-6 gestational weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Mar 2013 (estimated)
- Study startFeb 2013
- Primary completionJun 2015 (estimated)
- Study completionJun 2015 (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
- 1,200 participants (estimated)
- Target duration
- 12 Months
Sponsor and investigators
- Lead sponsor
- Progyny, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Shehua Shen, MD, Study director, Progyny, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01816802
- Sponsor's protocol ID
- 2012-AUX-009
- Other IDs
- TST 2193-p
- Acronym
- MERGE
- Status last verified
- Mar 2015
- First submitted
- 20 Mar 2013
- Last updated
- 26 Mar 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Mar 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- MERGE: MulticEnter ReGistry With Eeva
- ClinicalTrials.gov ID
- NCT01816802
- Acronym / sponsor ID
- MERGE / 2012-AUX-009
- Conditions
- Infertility
- Keywords
- In vitro fertilization, Assisted reproductive therapy, Time-lapse image recording, Image analysis software
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 1,200 participants (estimated)
- Lead sponsor
- Progyny, Inc.Industry (pharma, biotech, devices)
- Study start
- Feb 2013
- Primary completion
- Jun 2015 (estimated)
- Study completion
- Jun 2015 (estimated)
- First posted
- 22 Mar 2013 (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 study is to record and evaluate the use of traditional morphology grading combined with Eeva in the treatment of in vitro fertilization.
Detailed description
This is a prospective, observational, single-arm, nonrandomized, multicenter study. Data will be collected to establish eligibility, at baseline, during the stimulation and in vitro fertilization process, during embryo culture, at embryo transfer, at 12-18 days post egg retrieval to verify biochemical pregnancy, and then typically at 5-6 weeks gestational weeks to verify clinical pregnancy.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 12 Months
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| In-vitro fertilization using Eeva | – | Device: In-vitro fertilization using EevaPatients undergoing in-vitro fertilization treatment who provide informed consent and use Eeva in their treatment cycle. |
Who may qualify
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Patients undergoing in vitro fertilization treatment who provide informed consent and use Eeva in their treatment cycle.
Key inclusion criteria (1 listed)
- women undergoing fresh in vitro fertilization treatment using their own eggs or donor eggs.
Key exclusion criteria (2 listed)
- history of cancer.
- gestational carrier.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| In-vitro fertilization using EevaEeva will image embryos through cleavage stage (Day 3). Embryologists will use Eeva results along with traditional morphological grading to assist in selecting embryo(s) for transfer or freezing. | Device | In-vitro fertilization using Eeva |
Primary outcome
Clinical Pregnancy Rate
Time frame: 5-6 gestational weeks
Determined by first pregnancy ultrasound outcome and optional 12-month phone follow-up
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Mar 2015.
- Auxogyn, Inc. websiteLink 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 study director
Progyny, Inc.
12 sites 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 12 sites 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 1 inclusion and 2 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 26 Mar 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 12 sites 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?
Clinical Pregnancy Rate (time frame: 5-6 gestational weeks). 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 26 Mar 2015.