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The goal of this clinical trial is to investigate the impact of repeated antioxidant supplementation on blastocyst utilization and expansion rates in embryos under different oxygen concentrations. The study aims to answer the following main questions:
Participants in this study are infertile couples undergoing in vitro fertilization (IVF) or intracytoplasmic sperm injection (ICSI) cycles.
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.
This study is focused on the role of antioxidants (AOXs) in mitigating reactive oxygen species and oxidative stress, which have been associated with failure in in vitro fertilization (IVF) and intracytoplasmic sperm injection (ICSI). The research aimed to evaluate the effect of two different methods of antioxidants supplementation at two O2 tensions on blastocyst utilization and expansion rates. To achieve this, 3603 zygotes from infertile couples undergoing IVF or ICSI were included in the study. The zygotes were divided into two 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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| EmrbyORP continued at high O2 | Experimental | Antioxidants supplementation Every 12 hours (3.5 μL) |
|
| EmrbyORP at baseline with high O2 | Experimental | Antioxidants supplementation At baseline only (6.5 μL) |
|
| EmrbyORP continued at low 02 | Experimental | Antioxidants supplementation Every 12 hours (3.5 μL) |
|
| EmrbyORP at baseline with low o2 | Experimental | Antioxidants supplementation At baseline only (6.5 μL) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| EmbryORP® | Drug | EmbryORP® is a novel antioxidant (Cystein 32.9 mM, Glutation 32.6 mM, Ascorbic Acid 22.7 mM) |
|
| Measure | Description | Time Frame |
|---|---|---|
| Rate of usable blastocysts on day 5 | Usable blastocysts were defined as vitrified, transferred, and/or biopsied blastocysts at day 5 | 5 days |
| Rate of expanded blastocysts on day 5 | Expanded blastocysts were defined as usable blastocysts with a 4 to 6 expansion grade at day 5 | 5 days |
| Rate of sable blastocysts on day 6 | Usable blastocysts were defined as vitrified, transferred, and/or biopsied blastocysts at day 6 | 6 days |
| Rate of expanded blastocysts on day 6 | Expanded blastocysts were defined as usable blastocysts with a 4 to 6 expansion grade at day 6 | 6 days |
| Rate of acumulative usable blastocysts | Usable blastocysts were defined as vitrified, transferred, and/or biopsied blastocysts at days 5 and 6 | 5 - 6 days |
| Rate of acumulative expanded blastocysts. | Expanded blastocysts were defined as usable blastocysts with a 4 to 6 expansion grade at days 5 and 6 | 5 - 6 days |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Ashok Agarwal, PhD | Global Andrology Forum | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| CITMER | Mexico City | 11520 | Mexico |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| Background | 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. | ||
| 20570214 | Background | 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. | |
| 10655311 |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Oct 31, 2021 | Jun 9, 2023 | Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Oct 31, 2021 | Jun 9, 2023 | SAP_001.pdf |
| ICF | No | No | Yes | Informed Consent Form | Oct 31, 2021 | Jun 20, 2023 | ICF_002.pdf |
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| ID | Term |
|---|---|
| D007247 | Infertility, Female |
| D007248 | Infertility, Male |
| ID | Term |
|---|---|
| D005831 | Genital Diseases, Female |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
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The data registry utilized internal and external measures to ensure accuracy. SOPs were developed for registry operations and data analysis. Data were recorded in clinical records and clinic-specific databases. Regular backups and monthly audits were conducted to safeguard data and verify accuracy. External audits occurred every 6 months. Access controls protected privacy. Appropriate statistical techniques and sample size assessment were used for data analysis. A study on embryo development analyzed 3603 zygotes, assessing blastocyst outcomes and detailing procedures for ovarian stimulation, retrieval, sperm preparation, and assisted reproduction techniques. These measures ensured accurate and reliable results.
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|
| O2 tension 20% | Device | After fertilization check, zygotes were placed in the incubator at 37°C, 8% CO2, and 95% |
|
| O2 tension 5% | Device | After fertilization check, zygotes were placed in the incubator at 37°C, 8% CO2 and 95% |
|
| Background |
| 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. |
| 27012651 | Background | 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. |
| 9669527 | Background | 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. |
| 25044079 | Background | 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. |
| Background | 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 |
| 16018814 | Background | 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. |
| 23017782 | Background | 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. |
| 11284661 | Background | 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. |
| 32664650 | Background | 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. |
| 33550605 | Background | 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. |
| Background | 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. |
| Background | 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 |
| 29136144 | Background | 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. |
| 15374701 | Background | 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. |
| 16769062 | Background | 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. |
| 32299733 | Background | 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. |
| 28479756 | Background | 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. |
| 22829374 | Background | Swain JE. Media composition: pH and buffers. Methods Mol Biol. 2012;912:161-75. doi: 10.1007/978-1-61779-971-6_10. |
| 28497913 | Background | 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. |
| D000091662 | Genital Diseases |
| D007246 | Infertility |
| D005832 | Genital Diseases, Male |
| D052801 | Male Urogenital Diseases |