Amino Acid Profiling of Spent Culture Medium

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Total Enrollment

10 participants

Study Classification

OBSERVATIONAL

Study Start Date

2012-04-30

Study Completion Date

2013-04-30

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.

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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.

Conditions

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Infertility

Study Design

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Observational Model Type

COHORT

Study Time Perspective

RETROSPECTIVE

Study Groups

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IVF and ICSI patients

Subjects undergoing IVF or ICSI treatment with a maximum of 2 embryos transferred

No interventions assigned to this group

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).

Minimum Eligible Age

18 Years

Maximum Eligible Age

40 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No