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The clinical outcome of Ultra-low oxygen tension on post thawed human blastocyst
In vitro, Embryo development depends on several factors as temperature, pH, and oxygen in the surrounding environment of the embryo. Impaired culture conditions are highly correlated with poor embryo development. Oxygen is a powerful regulator of embryo function , as it is responsible for cell respiration, energy production and rapid cell growth . Increased levels of oxygen is associated with an increase in the levels of ROS , which leads to unfavorable culture conditions, as it might affect the stability of cell membrane, DNA, and protein function .
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Control arm (5% O2) | Other | 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 |
|
| Experimental arm (2%O2) | Experimental | 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 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 5% O2 | Other | Culturing embryos in 5% O2 just after thawing and till embryo transfer |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Clinical Pregnancy rate | Defined as the pregnancy that is confirmed by both high levels of hCG and ultrasound confirmation of a gestational sac or heartbeat | Time frame: 15 days following embryo transfer |
| Measure | Description | Time Frame |
|---|---|---|
| Ongoing pregnancy rate | Defined as the proportion of pregnancies that had completed ≥20 weeks of gestation | Time frame: 20 weeks of gestation |
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Inclusion Criteria:
Single or Multiple Embryo transfer embryo transfer. Female age 18-40. Embryo vitrified on day 5 or day 6 of insemination.
Exclusion Criteria:
Use of sperm donation. Use of Oocyte donation. Use of gestational carrier. Uterine congenital anomalies. Presence of any of the endometrial factors that affect embryo implantation such as hydrosalpings, adenomyosis or previously known uterine infection.
Any contradictions to undergoing in vitro fertilization or gonadotropin stimulation.
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Hosam Zaki, MSc, FRCOG | Contact | 00201222150018 | hosamz@tedata.net | |
| Salma El Tanbouly, BSc. | Contact | 00201279655807 | salmaeltanbouly@gmail.com |
| Name | Affiliation | Role |
|---|---|---|
| Hosam Zaki, MSc, FRCOG | Ganin Fertility Center, Cairo, Egypt. | Study Chair |
| Salma El Tanbouly, BSc. | Ganin Fertility Center, Cairo, Egypt. | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Ganin Fertility Center | Recruiting | Cairo | Egypt |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 26851765 | Background | 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. | |
| 26687905 | Background | 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. |
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| 2% O2 |
| Other |
Culturing embryos in 2% O2 just after thawing and till embryo transfer |
|
| Abd El Ghafar Hussin, BSc. |
| Ganin Fertility Center, Cairo, Egypt. |
| Principal Investigator |
| Hanaa El Khedr | Ganin Fertility Center, Cairo, Egypt. | Principal Investigator |
| 28181051 | Background | 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. |
| 28333022 | Background | 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. |
| 29935641 | Background | 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. |
| 29077897 | Background | 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. |
| 27007876 | Background | 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. |
| 9785193 | Background | 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. |