InfertilityNCT02788617
Evaluation of the Efficacy of Diafert in Predicting Embryos' Potential to Develop to the Blastocyst Stage
An observational study of Infertility, run by Forest Laboratories at 9 sites in United States.
Trial summary
This prospective study will evaluate the efficacy of Diafert as an adjunct to morphological assessment in predicting embryos' potential to develop to the blastocyst stage on Day 5. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Infertility
- What is being tested?
- Diafert
- Type of treatment
- Medical device
- How many people
- 100 participants
- Where
- 9 sitesUnited States
- Study dates
- 24 Jun 2016to 4 Apr 2017
- 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 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Study population: Female outpatients involved in an assisted reproduction procedure.
Who may be able to join
- Provide written informed consent before initiation of any study procedures
- Be a female outpatient, ≥ 18 years of age at the time of informed consent
- Have at minimum 10 mature egg follicles as of the last transvaginal ultrasound following hormonal stimulation
- Eligible to allow embryos to develop through day 5 before implantation or freezing
Who cannot join
- Presence of ovarian endometriotic cyst
- Presence or history of diagnosed severe endometriosis (i.e. stage IV the revised American Fertility Society classification for endometriosis).
- Need for pre-implantation genetic diagnosis/screening of embryos
- Use of time-lapse embryo imaging
- Employee or immediate relative of an employee of Forest Research Institute, Inc., any of its affiliates or partners, or the study center
Trial locations and contacts
9 sites in 1 country.
9 sites in 1 country
United States9 sites
Main Line Fertility Center
Bryn Mawr, Pennsylvania, 19010
Institute for Reproductive Health
Cincinnati, Ohio, 45209
Women's Medical Research Group
Clearwater, Florida, 33759
Dallas - Fort Worth Fertility Associates
Dallas, Texas, 75231
Huntington Reproductive Center
Encino, California, 91436
InVia Fertility Specialists
Hoffman Estates, Illinois, 60169
Houston Fertility Institute
Houston, Texas, 77063
Utah Fertiity Center
Pleasant Grove, Utah, 84062
Reproductive Care Center
Sandy City, Utah, 84092
About this study
Official title: A Prospective, Non-interventional, Multicenter, Clinical Study to Evaluate the Efficacy of the Diafert G-CSF ELISA as an Adjunct to Morphological Assessment in Predicting Embryos' Potential to Develop to the Blastocyst Stage
This prospective study will evaluate the efficacy of Diafert as an adjunct to morphological assessment in predicting embryos' potential to develop to the blastocyst stage on Day 5.
- Conditions
- Infertility
- Being tested
- Diafert
- Medical subject headings
- Infertility
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DiafertDevice
The Diafert output, the G-CSF concentration in FF, will be recorded but will not be used in patient management.
| Study group | Role | What they receive |
|---|---|---|
| Non treatment group | This is a non-interventional study in which embryo selection is performed according to standard of care. The Diafert output, the granulocyte colony-stimulating factor (G-CSF) concentration in follicular fluid (FF), will be recorded but will not be used in patient management, ie, values will not be used for embryo selection in the assisted reproduction procedure. Receives: Device: Diafert |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Embryos that achieve the blastocyst stage of development at Day 5 as determined by morphological assessment using the SART criteria
The status of each embryo will be assessed by an independent panel of 5 embryologists through visual inspection using the Society for Assisted Reproductive Technology (SART) criteria to determine if each embryo has achieved the blastocyst stage of development or not.
Measured: Day 5
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Jun 2016 (estimated)
- Study start24 Jun 2016
- Primary completion30 Jan 2017
- Study completion4 Apr 2017
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
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- Forest Laboratories
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Fabian Somers, PhD, Study director, Allergan
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02788617
- Sponsor's protocol ID
- DFT-MD-05
- Status last verified
- Jul 2017
- First submitted
- 26 Apr 2016
- Last updated
- 31 Jul 2017
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 31 Jul 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective, Non-interventional, Multicenter, Clinical Study to Evaluate the Efficacy of the Diafert G-CSF ELISA as an Adjunct to Morphological Assessment in Predicting Embryos' Potential to Develop to the Blastocyst Stage
- ClinicalTrials.gov ID
- NCT02788617
- Acronym / sponsor ID
- DFT-MD-05
- Conditions
- Infertility
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- Forest LaboratoriesIndustry (pharma, biotech, devices)
- Study start
- 24 Jun 2016 (actual)
- Primary completion
- 30 Jan 2017 (actual)
- Study completion
- 4 Apr 2017 (actual)
- First posted
- 2 Jun 2016 (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.
This prospective study will evaluate the efficacy of Diafert as an adjunct to morphological assessment in predicting embryos' potential to develop to the blastocyst stage on Day 5.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Non treatment group | – | Device: DiafertThis is a non-interventional study in which embryo selection is performed according to standard of care. The Diafert output, the granulocyte colony-stimulating factor (G-CSF) concentration in follicular fluid (FF), will be recorded but will not be used in patient management, ie, values will not be used for embryo selection in the assisted reproduction procedure. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Female outpatients involved in an assisted reproduction procedure.
Key inclusion criteria (4 listed)
- Provide written informed consent before initiation of any study procedures
- Be a female outpatient, ≥ 18 years of age at the time of informed consent
- Have at minimum 10 mature egg follicles as of the last transvaginal ultrasound following hormonal stimulation
- Eligible to allow embryos to develop through day 5 before implantation or freezing
Key exclusion criteria (5 listed)
- Presence of ovarian endometriotic cyst
- Presence or history of diagnosed severe endometriosis (i.e. stage IV the revised American Fertility Society classification for endometriosis).
- Need for pre-implantation genetic diagnosis/screening of embryos
- Use of time-lapse embryo imaging
- Employee or immediate relative of an employee of Forest Research Institute, Inc., any of its affiliates or partners, or the study center
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 |
|---|---|---|
| DiafertThe Diafert output, the G-CSF concentration in FF, will be recorded but will not be used in patient management. | Device | Non treatment group |
Primary outcome
Number of Embryos that achieve the blastocyst stage of development at Day 5 as determined by morphological assessment using the SART criteria
Time frame: Day 5
The status of each embryo will be assessed by an independent panel of 5 embryologists through visual inspection using the Society for Assisted Reproductive Technology (SART) criteria to determine if each embryo has achieved the blastocyst stage of development or not.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Jul 2017.
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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.
Fabian Somers, PhD study director
Allergan
9 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 Forest Laboratories at 9 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 4 inclusion and 5 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: finished, as of the sponsor's last update on 31 Jul 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 9 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Number of Embryos that achieve the blastocyst stage of development at Day 5 as determined by morphological assessment using the SART criteria (time frame: Day 5). 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 31 Jul 2017.