Effects of Antioxidant Supplementation of Culture Media on IVF Embryos
NCT ID: NCT05919186
Last Updated: 2023-06-26
Study Results
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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COMPLETED
NA
293 participants
INTERVENTIONAL
2021-10-12
2022-05-10
Brief Summary
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* Does adding antioxidants every 12 hours to embryo culture media improve usable and expanded blastocyst utilization rates on days 5 and 6?
* How are the O2 concentrations related to the effect of different methods of antioxidants supplementation on blastocysts utilization and expansion rates?
Participants in this study are infertile couples undergoing in vitro fertilization (IVF) or intracytoplasmic sperm injection (ICSI) cycles.
* Zygotes will be incubated at either 5% or 20% oxygen tension until the blastocyst stage.
* Sibling zygotes will be divided into four groups: Group 1A and 1B: Antioxidants every 12 hours at either 5% or 20% O2 tension, respectively. Group 2A and 2B: Antioxidants only once at the beginning of embryo culture at either 5% or 20% O2 tension, respectively.
Researchers will compare the four groups to determine if the repeated antioxidant supplementation of the culture media leads to improved blastocyst utilization and expansion rates compared to the baseline group.
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
BASIC_SCIENCE
SINGLE
Study Groups
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EmrbyORP continued at high O2
Antioxidants supplementation Every 12 hours (3.5 μL)
EmbryORP®
EmbryORP® is a novel antioxidant (Cystein 32.9 mM, Glutation 32.6 mM, Ascorbic Acid 22.7 mM)
O2 tension 20%
After fertilization check, zygotes were placed in the incubator at 37°C, 8% CO2, and 95%
EmrbyORP at baseline with high O2
Antioxidants supplementation At baseline only (6.5 μL)
EmbryORP®
EmbryORP® is a novel antioxidant (Cystein 32.9 mM, Glutation 32.6 mM, Ascorbic Acid 22.7 mM)
O2 tension 20%
After fertilization check, zygotes were placed in the incubator at 37°C, 8% CO2, and 95%
EmrbyORP continued at low 02
Antioxidants supplementation Every 12 hours (3.5 μL)
EmbryORP®
EmbryORP® is a novel antioxidant (Cystein 32.9 mM, Glutation 32.6 mM, Ascorbic Acid 22.7 mM)
O2 tension 5%
After fertilization check, zygotes were placed in the incubator at 37°C, 8% CO2 and 95%
EmrbyORP at baseline with low o2
Antioxidants supplementation At baseline only (6.5 μL)
EmbryORP®
EmbryORP® is a novel antioxidant (Cystein 32.9 mM, Glutation 32.6 mM, Ascorbic Acid 22.7 mM)
O2 tension 5%
After fertilization check, zygotes were placed in the incubator at 37°C, 8% CO2 and 95%
Interventions
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EmbryORP®
EmbryORP® is a novel antioxidant (Cystein 32.9 mM, Glutation 32.6 mM, Ascorbic Acid 22.7 mM)
O2 tension 20%
After fertilization check, zygotes were placed in the incubator at 37°C, 8% CO2, and 95%
O2 tension 5%
After fertilization check, zygotes were placed in the incubator at 37°C, 8% CO2 and 95%
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* More than 2 oocytes by conventional in vitro fertilization (cIVF) and intracytoplasmic sperm injection (ICSI).
Exclusion Criteria
* Infertile woman in assisted reproduction treatment with less than 2 oocytes fertilized by conventional in vitro fertilization (cIVF) and intracytoplasmic sperm injection (ICSI)
18 Years
37 Years
FEMALE
No
Sponsors
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Liliana Berenice Ramírez Domínguez
INDUSTRY
Responsible Party
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Liliana Berenice Ramírez Domínguez
Scientific Coordinator
Principal Investigators
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Ashok Agarwal, PhD
Role: STUDY_DIRECTOR
Global Andrology Forum
Locations
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CITMER
Mexico City, , Mexico
Countries
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References
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Khalied Kaskar, C. Optimizing embryo culture conditions and spent culture media analysis as predictors of em-bryo quality and pregnancy; PhD Thesis, University of the West Cape, Cape Town, South Africa, February 2021.
Swain JE. Optimizing the culture environment in the IVF laboratory: impact of pH and buffer capacity on gamete and embryo quality. Reprod Biomed Online. 2010 Jul;21(1):6-16. doi: 10.1016/j.rbmo.2010.03.012. Epub 2010 Mar 21.
Lane M, Lyons EA, Bavister BD. Cryopreservation reduces the ability of hamster 2-cell embryos to regulate intracellular pH. Hum Reprod. 2000 Feb;15(2):389-94. doi: 10.1093/humrep/15.2.389.
Nastri CO, Nobrega BN, Teixeira DM, Amorim J, Diniz LMM, Barbosa MWP, Giorgi VSI, Pileggi VN, Martins WP. Low versus atmospheric oxygen tension for embryo culture in assisted reproduction: a systematic review and meta-analysis. Fertil Steril. 2016 Jul;106(1):95-104.e17. doi: 10.1016/j.fertnstert.2016.02.037. Epub 2016 Mar 21.
Edwards LJ, Williams DA, Gardner DK. Intracellular pH of the preimplantation mouse embryo: effects of extracellular pH and weak acids. Mol Reprod Dev. 1998 Aug;50(4):434-42. doi: 10.1002/(SICI)1098-2795(199808)50:43.0.CO;2-J.
Hong KH, Lee H, Forman EJ, Upham KM, Scott RT Jr. Examining the temperature of embryo culture in in vitro fertilization: a randomized controlled trial comparing traditional core temperature (37 degrees C) to a more physiologic, cooler temperature (36 degrees C). Fertil Steril. 2014 Sep;102(3):767-73. doi: 10.1016/j.fertnstert.2014.06.009. Epub 2014 Jul 17.
Chui, A.; Kalionis, B.; Brennecke, S.; Murthi, P. 201 Homeobox Gene DLX3 Regulates Forskolin Induced Tropho-blast Differentiation. Reprod Fertil Dev 2008, 20(9), 1-1
Agarwal A, Gupta S, Sharma RK. Role of oxidative stress in female reproduction. Reprod Biol Endocrinol. 2005 Jul 14;3:28. doi: 10.1186/1477-7827-3-28.
Carocho M, Ferreira IC. A review on antioxidants, prooxidants and related controversy: natural and synthetic compounds, screening and analysis methodologies and future perspectives. Food Chem Toxicol. 2013 Jan;51:15-25. doi: 10.1016/j.fct.2012.09.021. Epub 2012 Sep 24.
Guerin P, El Mouatassim S, Menezo Y. Oxidative stress and protection against reactive oxygen species in the pre-implantation embryo and its surroundings. Hum Reprod Update. 2001 Mar-Apr;7(2):175-89. doi: 10.1093/humupd/7.2.175.
Budani MC, Tiboni GM. Effects of Supplementation with Natural Antioxidants on Oocytes and Preimplantation Embryos. Antioxidants (Basel). 2020 Jul 12;9(7):612. doi: 10.3390/antiox9070612.
Coria-Gomez CR, Torres-Rodriguez P, Villar-Munoz LG, Jimenez-Medina I, Agarwal A, Henkel R, Maldonado-Rosas I, L Trevino C. Comparative study of fertility parameters in vitrified human spermatozoa in the presence or absence of EmbryORP(R) : A novel antioxidant. Andrologia. 2021 May;53(4):e13886. doi: 10.1111/and.13886. Epub 2021 Feb 7.
David Gardner; William Schoolcraft. In Vitro Culture of Human Blastocysts. In Towards Reproductive Certainity: Fertility and Genetics Beyond 1999: The Plenary Proceedings of the 11th World Congress on In Vitro Fertilization & Hu-man Reproductive Genetics; Jansen, R., Mortimer, D., Eds.; Parthenon Publishing Group: London, 1999; Vol. 1, pp. 378-388.
Sallam, N.; Hegab, M.; Mohamed, F.; El-Kaffash, D. Effect of Oxidative Stress in Semen, Follicular Fluid and Em-bryo Culture Medium on the Outcome of Assisted Reproduction. Al-Azhar Internat Med J 2021, 2(7), 59-65, doi:10.21608/aimj.2021.79536.1495
Truong T, Gardner DK. Antioxidants improve IVF outcome and subsequent embryo development in the mouse. Hum Reprod. 2017 Dec 1;32(12):2404-2413. doi: 10.1093/humrep/dex330.
Bedaiwy MA, Falcone T, Mohamed MS, Aleem AA, Sharma RK, Worley SE, Thornton J, Agarwal A. Differential growth of human embryos in vitro: role of reactive oxygen species. Fertil Steril. 2004 Sep;82(3):593-600. doi: 10.1016/j.fertnstert.2004.02.121.
Bedaiwy M, Agarwal A, Said TM, Goldberg JM, Sharma RK, Worley S, Falcone T. Role of total antioxidant capacity in the differential growth of human embryos in vitro. Fertil Steril. 2006 Aug;86(2):304-9. doi: 10.1016/j.fertnstert.2006.01.025. Epub 2006 Jun 12.
Gardner DK, Kuramoto T, Tanaka M, Mitzumoto S, Montag M, Yoshida A. Prospective randomized multicentre comparison on sibling oocytes comparing G-Series media system with antioxidants versus standard G-Series media system. Reprod Biomed Online. 2020 May;40(5):637-644. doi: 10.1016/j.rbmo.2020.01.026. Epub 2020 Feb 5.
Majumdar G, Majumdar A, Verma IC, Upadhyaya KC. Relationship Between Morphology, Euploidy and Implantation Potential of Cleavage and Blastocyst Stage Embryos. J Hum Reprod Sci. 2017 Jan-Mar;10(1):49-57. doi: 10.4103/0974-1208.204013.
Swain JE. Media composition: pH and buffers. Methods Mol Biol. 2012;912:161-75. doi: 10.1007/978-1-61779-971-6_10.
Agarwal A, Majzoub A. Role of Antioxidants in Assisted Reproductive Techniques. World J Mens Health. 2017 Aug;35(2):77-93. doi: 10.5534/wjmh.2017.35.2.77. Epub 2017 Apr 30.
Provided Documents
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Document Type: Study Protocol
Document Type: Statistical Analysis Plan
Document Type: Informed Consent Form
Other Identifiers
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CI-20-102
Identifier Type: -
Identifier Source: org_study_id
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