Amino Acid Profiling of Spent Culture Medium

Study Overview
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Brief Summary
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The purpose of this study is to develop an algorithm for embryo selection based on amino acid profiling (AAP) of spent culture medium. Development of the algorithm will be based on the ongoing implantation rate of the individual embryos transferred. As evaluated by ultrasound scan in gestational week 7.

Detailed Description
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IVF/ICSI treatment has permitted many thousands of couples to conceive worldwide yet is limited by low success rates (in UK, approx. 25% live birth rate/treatment cycle for women up to 42 years of age; HFEA Annual Report, 2006) and a confounding high multiple birth rate (23%) due to the transfer of more than a single pre-implantation embryo. Multiple births are associated with prematurity, increased neonatal and maternal mortality and child handicap as well as being a major burden for health care systems. These problems have been highlighted in the data published by the HFEA (2009), which has called for a professionally-led, coordinated national strategy to reduce the number of multiple births. This challenge could be met if single embryos of known developmental competence could be selected for transfer, thereby making the embryo selection process even more crucial. However, current non-invasive embryo selection criteria using light microscope analysis have limited predictive value for ongoing pregnancy.

Official Title
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Amino Acid Profiling of Spent Culture Medium to Retrospectively Determine Individual Embryo Selection Criteria for Improved Clinical IVF Outcome

Conditions
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Infertility

Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Minimum 4 x 2PN´s on Day 1 post insemination Subjects undergoing IVF or ICSI treatment with a maximum of 2 embryos transferred Both partners should be capable of understanding the study to which they are consenting Females > 18 and ≤ 40 years of age Regular menstrual cycle 21-35 days (both inclusive) Women treated with a standard drug protocol Exclusion Criteria: The couple has previously participated in the DK005 study Use of assisted hatching Indication for TESA or PESA Any medical conditions or genetic disorders prohibiting IVF/ICSI or interfering with the interpretation of results of the study (including pre- implantation genetic diagnostics). Use of any investigational drug within 30 days before oocyte retrieval Any severe chronic disease of relevance for reproductive function. Oocyte donation patients (donor or recipient).

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 40 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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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| IVF and ICSI patients<br>Subjects undergoing IVF or ICSI treatment with a maximum of 2 embryos transferred | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Amino acid profile | Amino acid profiling (AAP) will be performed of spent culture medium from individually cultured embryos. AAP results will be correlated to the ongoing implantation rate week 7 as well as morphological embryo development parametres. | After 24 hours of culture | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Ongoing clinical pregnancy rate | Evaluated by ultrasound scan | Gestational week 7 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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ART, IVF, ICSI, embryo selection