InfertilityPhase 3DESTINyNCT02593513
Diafert for Embryo Selection and Fertility Improvement (DESTINy)
A Phase 3 study testing Daifert in people with Infertility, run by Forest Laboratories at 1 site in Hungary.
Trial summary
Prospective, single-center, single-blind, randomized, controlled, two-arm, interventional study. 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?
- Daifert
- Type of treatment
- Medical device, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 108 participants
- Where
- 1 siteHungary
- Study dates
- 26 Oct 2015to 7 Apr 2017
- Phase
- Phase 3
- 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
Who may be able to join
- Women at least 18 years old at the time of Informed Consent.
- Able to understand and voluntarily sign an Informed Consent form approved by the relevant Independent Ethics Committee (IEC) governing the site.
- First or second fresh Assisted Reproductive Technology (ART) cycle attempt (since last successful implantation, if any).
- Eligible for elective SET of fresh embryo on Day 2/3. Elective SET is defined as a transfer for which there is more than one embryo in the same morphological ("best") category as that of the selected embryo.
Who cannot join
- Presence or history of ovarian endometriotic cyst.
- Presence or history of diagnosed severe endometriosis (i.e. stage IV of the revised American Fertility Society classification for endometriosis).
- Hormonal, functional, anatomical and/or other abnormalities potentially increasing the risk of miscarriage and/or ectopic pregnancy as judged by the Investigator and determined by medical history and clinical laboratory. This includes, but is not limited to, uncontrolled diabetes mellitus, uncontrolled thyroid disease, alcoholism, drug abuse, abnormal uterine cavity etc.
- History of two or more consecutive miscarriages.
- Known history of human immunodeficiency virus, Hepatitis C virus and/or Hepatitis B virus infection.
- The subject has other serious or acute conditions that, in the Investigator's opinion, would preclude her participation in the study.
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- Need for preimplantation genetic diagnosis/screening.
- Use of time-lapse embryo imaging
- Participating in oocyte donation procedure.
- Participation in any interventional drug clinical investigation within 2 months prior to screening.
- Dependency on sponsor or investigator (e.g. co-worker or family member).
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Prospective, Single-center, Randomized, Two-arm, Interventional Study to Evaluate the Implantation Rate of Embryos Selected on the Basis of Morphology and Granulocyte-Colony Stimulating Factor (G-CSF) Concentration in the Ovarian Follicular Fluid (FF) - FF G-CSF - Compared to the Implantation Rate of Embryos Selected on the Basis of Morphology Alone When Elective Single Embryo Transfer (SET) of a Fresh Embryo is Performed on Day 2/3 After Oocyte Retrieval
Prospective, single-center, single-blind, randomized, controlled, two-arm, interventional study.
- Conditions
- Infertility
- Being tested
- Daifert, Control Group
- Keywords
- Embryo Transfer, Embryo Selection Criteria for Implantation, Assisted Reproductive Technology
- Medical subject headings
- Infertility
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DaifertDevice
Control GroupProcedure or surgery
Control - Morphological Assessment
| Study group | Role | What they receive |
|---|---|---|
| Daifert | Experimental | The embryo to be transferred is selected on the basis of both morphological assessment performed on Day 2 or 3 and FF G-CSF concentration. FF G-CSF concentration will be measured with the Diafert® immunoassay. Receives: Device: Daifert |
| Control Group | Other | The embryo to be transferred is selected on the basis of morphological assessment performed on Day 2 or 3. Receives: Procedure: Control Group |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of successful implantations
The percentage of successful implantation 6 weeks after oocyte retrieval (±3 days), i.e. at approximately 8 weeks gestational age (±3 days) or 8 weeks of amenorrhea (± 3 days), in each group (Control and Interventional groups), overall and within each morphological embryo category, when elective Single Embryo Transfer (SET) is performed on Day 2 or 3.
Successful implantation is defined as the presence in the uterus of at least one gestational sac with fetal heart activity identified on ultrasound.
Measured: At Week 6
Secondary outcomes (1)
Percentage of live births
Percentage of live birth in the Control group and in the Interventional group when elective SET of a fresh embryo is performed on Day 2 or 3 after oocyte retrieval.
Measured: Approximately Week 40 (pregnancy outcome)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Nov 2015 (estimated)
- Study start26 Oct 2015
- Primary completion22 Feb 2017
- Study completion7 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
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 108 participants (actual)
Sponsor and investigators
- Lead sponsor
- Forest Laboratories
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Tennador Sanderson, Study director, Forest Laboratories, an affiliate of Allergan plc
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02593513
- Sponsor's protocol ID
- 0040-103
- Acronym
- DESTINy
- Status last verified
- Jul 2017
- First submitted
- 22 Oct 2015
- Last updated
- 1 Aug 2017
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Aug 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective, Single-center, Randomized, Two-arm, Interventional Study to Evaluate the Implantation Rate of Embryos Selected on the Basis of Morphology and Granulocyte-Colony Stimulating Factor (G-CSF) Concentration in the Ovarian Follicular Fluid (FF) - FF G-CSF - Compared to the Implantation Rate of Embryos Selected on the Basis of Morphology Alone When Elective Single Embryo Transfer (SET) of a Fresh Embryo is Performed on Day 2/3 After Oocyte Retrieval
- ClinicalTrials.gov ID
- NCT02593513
- Acronym / sponsor ID
- DESTINy / 0040-103
- Conditions
- Infertility
- Keywords
- Embryo Transfer, Embryo Selection Criteria for Implantation, Assisted Reproductive Technology
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 108 participants (actual)
- Lead sponsor
- Forest LaboratoriesIndustry (pharma, biotech, devices)
- Study start
- 26 Oct 2015 (actual)
- Primary completion
- 22 Feb 2017 (actual)
- Study completion
- 7 Apr 2017 (actual)
- First posted
- 2 Nov 2015 (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.
Prospective, single-center, single-blind, randomized, controlled, two-arm, interventional study.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Daifert | Experimental | Device: DaifertThe embryo to be transferred is selected on the basis of both morphological assessment performed on Day 2 or 3 and FF G-CSF concentration. FF G-CSF concentration will be measured with the Diafert® immunoassay. |
| Control Group | Other | Procedure: Control GroupThe embryo to be transferred is selected on the basis of morphological assessment performed on Day 2 or 3. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Women at least 18 years old at the time of Informed Consent.
- Able to understand and voluntarily sign an Informed Consent form approved by the relevant Independent Ethics Committee (IEC) governing the site.
- First or second fresh Assisted Reproductive Technology (ART) cycle attempt (since last successful implantation, if any).
- Eligible for elective SET of fresh embryo on Day 2/3. Elective SET is defined as a transfer for which there is more than one embryo in the same morphological ("best") category as that of the selected embryo.
Key exclusion criteria (11 listed)
- Presence or history of ovarian endometriotic cyst.
- Presence or history of diagnosed severe endometriosis (i.e. stage IV of the revised American Fertility Society classification for endometriosis).
- Hormonal, functional, anatomical and/or other abnormalities potentially increasing the risk of miscarriage and/or ectopic pregnancy as judged by the Investigator and determined by medical history and clinical laboratory. This includes, but is not limited to, uncontrolled diabetes mellitus, uncontrolled thyroid disease, alcoholism, drug abuse, abnormal uterine cavity etc.
- History of two or more consecutive miscarriages.
- Known history of human immunodeficiency virus, Hepatitis C virus and/or Hepatitis B virus infection.
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 |
|---|---|---|
| Daifert | Device | Daifert |
| Control GroupControl - Morphological Assessment | Procedure or surgery | Control Group |
Primary outcome
Percentage of successful implantations
Time frame: At Week 6
The percentage of successful implantation 6 weeks after oocyte retrieval (±3 days), i.e. at approximately 8 weeks gestational age (±3 days) or 8 weeks of amenorrhea (± 3 days), in each group (Control and Interventional groups), overall and within each morphological embryo category, when elective Single Embryo Transfer (SET) is performed on Day 2 or 3. Successful implantation is defined as the presence in the uterus of at least one gestational sac with fetal heart activity identified on ultrasound.
1 secondary outcome
Percentage of live births
Time frame: Approximately Week 40 (pregnancy outcome)
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 1 Aug 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.
Tennador Sanderson study director
Forest Laboratories, an affiliate of Allergan plc
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Daifert in people with Infertility, run by Forest Laboratories at 1 site in Hungary.
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 11 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 1 Aug 2017. 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 Hungary. 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.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Percentage of successful implantations (time frame: At Week 6). 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 1 Aug 2017.