Back to resultsDiafert for Embryo Selection and Fertility Improvement (DESTINy)
Primary Purpose
Infertility
Status
Completed
Phase
Phase 3
Locations
Belgium
Study Type
Interventional
Intervention
Daifert
Control Group
Sponsored by
About this trial
This is an interventional treatment trial for Infertility focused on measuring Embryo Transfer, assisted reproductive technology
Eligibility Criteria
Inclusion Criteria:
- 1. Women at least 18 years old at the time of informed consent.
- 2. Able to understand and voluntarily sign an Informed Consent form approved by the relevant Independent Ethics Committee (IEC) governing the site.
- 3. First or second fresh Assisted Reproductive Technology (ART) cycle attempt (since last successful implantation, if any).
- 4. 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.
Exclusion Criteria:
- 1. Presence or history of ovarian endometriotic cyst.
- 2. Presence or history of diagnosed severe endometriosis (i.e. stage IV the revised American Fertility Society classification for endometriosis).
- 3. Hormonal, functional, anatomical and/or any 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.
- 4. History of two or more consecutive miscarriages.
- 5. Known history of human immunodeficiency virus, Hepatitis C virus and/or Hepatitis B virus infection.
- 6. The subject has other serious or acute conditions that, in the Investigator's opinion, would preclude her participation in the study.
- 7. Need for preimplantation genetic diagnosis/screening.
- 8. Use of time-lapse embryo imaging.
- 9. Participating in oocyte donation procedure.
- 10. Participation in any interventional drug clinical investigation within 2 months prior to screening.
- 11. Dependency on sponsor or investigator (e.g. co-worker or family member).
Sites / Locations
- Leuven University Fertility Center
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Other
Arm Label
Daifert
Control Group
Arm Description
• Interventional Group: 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.
Control Group: The embryo to be transferred is selected on the basis of morphological assessment performed on Day 2 or 3.
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
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.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT02586272
Brief Title
Diafert for Embryo Selection and Fertility Improvement
Acronym
DESTINy
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.
Study Type
Interventional
2. Study Status
Record Verification Date
July 2017
Overall Recruitment Status
Completed
Study Start Date
November 25, 2014 (Actual)
Primary Completion Date
February 22, 2017 (Actual)
Study Completion Date
April 7, 2017 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Forest Laboratories
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
Prospective, single-center, single-blind, randomized, controlled, two-arm, interventional study.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Infertility
Keywords
Embryo Transfer, assisted reproductive technology
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
61 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Daifert
Arm Type
Experimental
Arm Description
• Interventional Group: 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.
Arm Title
Control Group
Arm Type
Other
Arm Description
Control Group: The embryo to be transferred is selected on the basis of morphological assessment performed on Day 2 or 3.
Intervention Type
Device
Intervention Name(s)
Daifert
Intervention Type
Procedure
Intervention Name(s)
Control Group
Other Intervention Name(s)
Control - Morphological Assessment
Primary Outcome Measure Information:
Title
Percentage of successful implantations
Description
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.
Time Frame
At Week 6
Secondary Outcome Measure Information:
Title
Percentage of live births
Description
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.
Time Frame
Approximately Week 40 (pregnancy outcome)
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
1. Women at least 18 years old at the time of informed consent.
2. Able to understand and voluntarily sign an Informed Consent form approved by the relevant Independent Ethics Committee (IEC) governing the site.
3. First or second fresh Assisted Reproductive Technology (ART) cycle attempt (since last successful implantation, if any).
4. 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.
Exclusion Criteria:
1. Presence or history of ovarian endometriotic cyst.
2. Presence or history of diagnosed severe endometriosis (i.e. stage IV the revised American Fertility Society classification for endometriosis).
3. Hormonal, functional, anatomical and/or any 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.
4. History of two or more consecutive miscarriages.
5. Known history of human immunodeficiency virus, Hepatitis C virus and/or Hepatitis B virus infection.
6. The subject has other serious or acute conditions that, in the Investigator's opinion, would preclude her participation in the study.
7. Need for preimplantation genetic diagnosis/screening.
8. Use of time-lapse embryo imaging.
9. Participating in oocyte donation procedure.
10. Participation in any interventional drug clinical investigation within 2 months prior to screening.
11. Dependency on sponsor or investigator (e.g. co-worker or family member).
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Tennador Sanderson
Organizational Affiliation
Forest Laboratories, an affiliate of Allergan plc
Official's Role
Study Director
Facility Information:
Facility Name
Leuven University Fertility Center
City
Leuven
ZIP/Postal Code
B-3000
Country
Belgium
12. IPD Sharing Statement
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Diafert for Embryo Selection and Fertility Improvement
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