Impact of Human Embryo Culture System on Live Birth

Study Overview
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Brief Summary
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Previous studies in human and different mammals have proved that the embryo group culture (in the same culture medium drop) using a reduced volume is associated with a better embryo development. This is due to the effect of different autocrine and paracrine factors secreted by the embryos. Besides, previous studies with embryos from human and other mammals have shown that a high oxygen concentration may have a negative effect on embryo quality due to the generation of reactive oxygen species, which cause oxidative stress. The embryo culture at low oxygen tension is correlated to better success rates in IVF/ICSI treatments. The purpose of this study is to evaluate the combined effect of the embryo group culture and the low oxygen tension on the embryo development and the results of the IVF/ICSI treatments. The specific goal is to compare the embryo group culture in a reduced volume of medium at a low oxygen tension (5%) with the standard individual culture at an atmospheric oxygen tension (20%). The first culture condition will be applied in a K-MINC incubator (COOK Medical®), whereas the second condition will be applied using a Heracell incubator (Heraeus®).

Official Title
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Improvement of Live Birth Rate With a New Standardized Human Embryo Culture System: a Prospective, Randomized, Controlled Trial

Conditions
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Embryo Culture

Intervention / Treatment
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* Procedure: New Culture Condition
* Procedure: Standard Culture Condition


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: <38 years (with own oocytes) / <45 years (with oocyte donation). First treatment with own oocytes / any treatment with oocyte donation. ≥10 oocytes with a diameter of ≥10 mm. Exclusion Criteria: Diseases that affect endometrial receptivity: endometriosis, hydrosalpinx, ovarian hyperstimulation syndrome, obesity, endocrinopathies, thrombophilia, congenital or acquired uterine anomalies. Patients under a treatment with genetic preimplantation diagnosis.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 38 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: New Culture Condition<br>Intervention group embryos cultured grouped under low oxygen tension in benchtop incubators. | Procedure: New Culture Condition<br>* Intervention group embryos cultured grouped (5 embryos per drop) under low oxygen tension (5%) in benchtop incubators.<br>|
| Active Comparator: Standard Culture Condition<br>Control group embryos cultured individually under atmospheric oxygen tension in large-box incubators. | Procedure: Standard Culture Condition<br>* Control group embryos cultured individually (1 embryo per drop) under atmospheric oxygen tension (20%) in large-box incubators.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Clinical pregnancy rate | Confirmed when a gestational sac with heartbeat was observed in the uterus by ultrasound examination, performed 2-3 weeks after the positive result of the beta-hCG pregnancy test. | April 2013 - October 2016 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Implantation rate | Number of embryos implanted per number of embryos transferred | April 2013 - October 2016 | 
| Live birth rate | Number of newborns per pregnancy achieved | April 2013 - October 2016 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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grouped embryo culture, embryo density, low oxygen, benchtop incubator, culture condition