The Clinical Outcome of Ultra-low Oxygen Tension on Post Thawed Human Blastocyst
NCT ID: NCT03817671
Last Updated: 2019-01-28
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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UNKNOWN
NA
168 participants
INTERVENTIONAL
2018-11-20
2020-06-30
Brief Summary
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Detailed Description
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In the female reproductive tract, oxygen concentration fluctuates between 2-8%, which is considered to be at its highest level in the fallopian tube, while the lowest level is in the uterus . Pre-implantation embryo crosses the uterotubal junction after the time of compaction on Day 3, where it is exposed to a shift in oxygen tension to 2%. This variation may have a role in the metabolic reactions of the embryo, and in its preparation for implantation process.
Some studies suggested that culturing embryos with oxygen tension below 5% may have an embryological advantage mimicking nature.
Embryological laboratories routinely use low Oxygen tension (5%). Our purpose is to investigate if ultra-low oxygen tension (2%) has an advantage over low oxygen tension (5%) for post thawed human embryo regarding clinical outcomes.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
OTHER
NONE
Study Groups
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Control arm (5% O2)
After thawing, embryos will be cultured in 25 μl drop of pre-equilibrated dishes of media covered with a layer of oil for 1.5 hours at 5.7% CO2, 5% O2, and 89.3% N2 till embryo transfer
5% O2
Culturing embryos in 5% O2 just after thawing and till embryo transfer
Experimental arm (2%O2)
After thawing, embryos will be cultured in 25 μl drop of pre-equilibrated dishes of media covered with a layer of oil for 1.5 hours at 5.7% CO2, 2% O2, and 92.3% N2 till embryo transfer
2% O2
Culturing embryos in 2% O2 just after thawing and till embryo transfer
Interventions
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5% O2
Culturing embryos in 5% O2 just after thawing and till embryo transfer
2% O2
Culturing embryos in 2% O2 just after thawing and till embryo transfer
Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
Any contradictions to undergoing in vitro fertilization or gonadotropin stimulation.
5 Days
6 Days
ALL
No
Sponsors
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Ganin Fertility Center
OTHER
Responsible Party
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Salma El Tanbouly
Senior Clinical Embryologist
Principal Investigators
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Hosam Zaki, MSc, FRCOG
Role: STUDY_CHAIR
Ganin Fertility Center, Cairo, Egypt.
Salma El Tanbouly, BSc.
Role: PRINCIPAL_INVESTIGATOR
Ganin Fertility Center, Cairo, Egypt.
Abd El Ghafar Hussin, BSc.
Role: PRINCIPAL_INVESTIGATOR
Ganin Fertility Center, Cairo, Egypt.
Hanaa El Khedr
Role: PRINCIPAL_INVESTIGATOR
Ganin Fertility Center, Cairo, Egypt.
Locations
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Ganin Fertility Center
Cairo, , Egypt
Countries
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Central Contacts
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Facility Contacts
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References
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Swain JE, Carrell D, Cobo A, Meseguer M, Rubio C, Smith GD. Optimizing the culture environment and embryo manipulation to help maintain embryo developmental potential. Fertil Steril. 2016 Mar;105(3):571-587. doi: 10.1016/j.fertnstert.2016.01.035. Epub 2016 Feb 3.
Gardner DK. The impact of physiological oxygen during culture, and vitrification for cryopreservation, on the outcome of extended culture in human IVF. Reprod Biomed Online. 2016 Feb;32(2):137-41. doi: 10.1016/j.rbmo.2015.11.008. Epub 2015 Nov 25.
Morin SJ. Oxygen tension in embryo culture: does a shift to 2% O2 in extended culture represent the most physiologic system? J Assist Reprod Genet. 2017 Mar;34(3):309-314. doi: 10.1007/s10815-017-0880-z. Epub 2017 Feb 8.
Oliveira JB. Does embryo culture at low oxygen tension improve ART outcomes? JBRA Assist Reprod. 2017 Feb 1;21(1):1. doi: 10.5935/1518-0557.20170001. No abstract available.
Kaser DJ, Bogale B, Sarda V, Farland LV, Williams PL, Racowsky C. Randomized controlled trial of low (5%) versus ultralow (2%) oxygen for extended culture using bipronucleate and tripronucleate human preimplantation embryos. Fertil Steril. 2018 Jun;109(6):1030-1037.e2. doi: 10.1016/j.fertnstert.2018.02.119.
Ng KYB, Mingels R, Morgan H, Macklon N, Cheong Y. In vivo oxygen, temperature and pH dynamics in the female reproductive tract and their importance in human conception: a systematic review. Hum Reprod Update. 2018 Jan 1;24(1):15-34. doi: 10.1093/humupd/dmx028.
Yang Y, Xu Y, Ding C, Khoudja RY, Lin M, Awonuga AO, Dai J, Puscheck EE, Rappolee DA, Zhou C. Comparison of 2, 5, and 20 % O2 on the development of post-thaw human embryos. J Assist Reprod Genet. 2016 Jul;33(7):919-27. doi: 10.1007/s10815-016-0693-5. Epub 2016 Mar 23.
Leese HJ. Human embryo culture: back to nature. J Assist Reprod Genet. 1998 Sep;15(8):466-8. doi: 10.1023/a:1022526219202. No abstract available.
Other Identifiers
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GFCST11991
Identifier Type: -
Identifier Source: org_study_id
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