Diafert for Embryo Selection and Fertility Improvement

Study Overview
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Brief Summary
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Prospective, single-center, single-blind, randomized, controlled, two-arm, interventional study.

Official Title
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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.

Conditions
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Infertility

Intervention / Treatment
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* Device: Daifert
* Procedure: Control Group


Participation Criteria
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Eligibility Criteria
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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).

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Daifert<br>• 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. | Device: Daifert<br> <br> |
| Other: Control Group<br>Control Group: The embryo to be transferred is selected on the basis of morphological assessment performed on Day 2 or 3. | Procedure: Control Group<br> <br> * Other names: Control - Morphological Assessment;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | At Week 6 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | Approximately Week 40 (pregnancy outcome) | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Embryo Transfer, assisted reproductive technology