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One of the most sensible factors in IVF culture conditions is the susceptibility of gametes and embryos to an induced increase in reactive oxidative species (ROS) caused by the artificial environment. This study aims to evaluate the impact of using antioxidant-supplemented media during culture to evaluate embryo ploidy rates in a prospective randomized trial using sibling oocytes.
Improvements in culture conditions is an ongoing process in IVF due to, on one hand, the still lack of knowledge on human embryonic development, and, on the other hand, the frequent need for repeated IVF cycles to achieve an 'implantable' embryo. The main factor for optimizing conditions of an embryo to develop is its microenvironment, mainly the culture media used. One of the most sensible factors in IVF culture conditions is the susceptibility of gametes and embryos to an induced increase in reactive oxidative species (ROS) caused by the artificial environment, as it has been extensively shown in animal models and to a certain extent in humans.
A primordial step for improvement is to alleviate an increase in ROS during embryo development. This can be manipulated by means of utilizing a culture media with supplements that can serve as scavengers, leading to an equilibrium between oxidation and reduction of ROS during the culture period. So far, the produced culture media contain low concentrations of limited additives involved in anti-oxidative stress. Recently, a culture medium containing an implementation in higher doses of distinctive elements known to clearly serve as cellular scavengers has been formulated. However, very few human IVF studies have been performed up to date. Our research intends to investigate the incorporation of antioxidant-rich culture media into IVF practices with the primary objective of analyzing its impact on embryo euploidy, as well as the previous culture steps including fertilization and blastocyst developmental rates. This study aims to evaluate the impact of using antioxidant-supplemented media during culture to evaluate embryo ploidy rates in a prospective randomized trial using sibling oocytes.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Group 1: antioxidants-enriched culture medium (Gx) | Active Comparator | Blastocyst exposed to antioxidants-enriched culture medium (Gx) in continuous culture conditions, without refreshment on day 3. A refreshment of the media will be done on D5 in both groups. |
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| Group 2: Global total one step media (GT) | Active Comparator | Blastocyst exposed to Global total one step media (GT) in continuous culture conditions, without refreshment on day 3. A refreshment of the media will be done on D5 in both groups. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| antioxidants-enriched culture medium (Gx) | Drug | Blastocyst will be in continuous culture conditions (parallel antioxidants-enriched culture medium (Gx) and Global total one step media (GT) without refreshment on day 3. A refreshment of the media will be done on D5 in both groups. |
| Measure | Description | Time Frame |
|---|---|---|
| Blastocyst ploidy is determined after a biopsy of trophectoderm cells, taken from the blastocyst on day 5, 6 or 7 from development. The following outcomes are possible: • Normal • Abnormal • No result/Inconclusive • Low or high Mosaic | Ploidy rate is calculated by dividing the number of normal embryos by the number of blastocysts biopsied in the group. | 1 year |
| Measure | Description | Time Frame |
|---|---|---|
| Cycle ploidy rate: the number of euploid embryos in the group Blastocyst quality at the time of biopsy based on modified Gardner's criteria. Usable blastocyst rate per group and per day of biopsy (day 5, 6, 7) | Ploidy rate is calculated by dividing the number of normal embryos by the number of blastocysts biopsied in the group. | 1 year |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Daniela Nogueira | Contact | +971504374961 | daniela.nogueira@artfertilityclinics.com | |
| Jonalyn DV Edades | Contact | +971526408688 | jonalyn.ededas@artfertilityclinics.com |
| Name | Affiliation | Role |
|---|---|---|
| Barbara Lawrenz | ART Fertility Clinics LLC | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| ART Fertility Clinics LLC | Recruiting | Abu Dhabi | Abu Dhabi Emirate | 60202 | United Arab Emirates |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 26812244 | Background | Meldrum DR, Casper RF, Diez-Juan A, Simon C, Domar AD, Frydman R. Aging and the environment affect gamete and embryo potential: can we intervene? Fertil Steril. 2016 Mar;105(3):548-559. doi: 10.1016/j.fertnstert.2016.01.013. Epub 2016 Jan 23. | |
| 31861967 | Background | von Mengden L, Klamt F, Smitz J. Redox Biology of Human Cumulus Cells: Basic Concepts, Impact on Oocyte Quality, and Potential Clinical Use. Antioxid Redox Signal. 2020 Mar 10;32(8):522-535. doi: 10.1089/ars.2019.7984. |
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| ID | Term |
|---|---|
| D007246 | Infertility |
| ID | Term |
|---|---|
| D000091662 | Genital Diseases |
| D000091642 | Urogenital Diseases |
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A randomization list (indicating Gx Media Vitrolife or GT Coopersurgical) will be used to verify to which group the first half of oocytes will be allocated to. In case an odd number of oocytes is present, one extra oocyte is allocated to the group as indicated by the randomization list.
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