Use of Nitric Oxide Metabolites for Predicting Embryo Quality in In-Vitro Fertilization (IVF)

Study Overview
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Brief Summary
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Improvements in In-Vitro Fertilization (IVF) outcomes have largely been due to the generation of excess embryos allowing for multiple embryo transfer. Unfortunately this has also increased the risk of multiple pregnancy with associated maternal and neonatal morbidity and mortality. The investigators believe that the concentration of nitric oxide metabolites measured in the culture medium from the first day of culture can identify the best quality embryos allowing us to transfer a limited number of embryos without compromising the optimum chance for pregnancy.

Official Title
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Use of Nitric Oxide Metabolites for Predicting Embryo Quality in In-Vitro Fertilization

Conditions
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Infertility

Intervention / Treatment
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* Procedure: Transfer of embryos on day 3 or day 5 after fertilization.
* Procedure: Day 5 transfer


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Age 21-37 Female Less than two previous unsuccessful IVF cycles Exclusion Criteria: Day 3 FSH >9.9 Fewer than 8 mature oocytes retrieved Fewer than 8 normally fertilized embryos on day 2 after fertilization

Ages Eligible for Study
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Minimum Age: 21 Years
Maximum Age: 37 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

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: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Day 3 transfer<br>Subjects in this arm will have two embryos transferred three days after fertilization. Embryos will be selected based on the concentration of nitric oxide metabolites in the culture medium. | Procedure: Transfer of embryos on day 3 or day 5 after fertilization.<br>* Subjects will be allocated at random to the two arms. Group 1 will have two embryos transferred on day 3 based on nitric oxide concentration. Group 2 will have two embryos transferred on day 5 based on morphologic criteria.<br>|
| Active Comparator: Day 5 transfer<br>Subjects will have two embryos transferred on day 5 after fertilization with selection of embryos based on morphologic criteria. | Procedure: Day 5 transfer<br>* Subjects will have embryo transfer on day 5 after fertilization. Selection of embryos to transfer will be based on morphologic criteria.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percentage of subjects with viable pregnancy one month after embryo transfer |  | 1 month | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percentage of subjects with > 2 viable embryos one month after embryo transfer |  | 1 month | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Infertility, Assisted reproductive technology, Nitric oxide