The Clinical Outcome of Ultra-low Oxygen Tension on Post Thawed Human Blastocyst

Embryo Development Clinical Trial

Official title:

The Clinical Outcome of Ultra-low Oxygen Tension on Post Thawed Human Blastocyst

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03817671
• Other study ID #: GFCST11991
• Status: Recruiting
• Phase: N/A
• Start date: November 20, 2018
• Est. completion date: June 30, 2020

Study information

• Verified date: January 2019
• Source: Ganin Fertility Center
• Contact: Hosam Zaki, MSc, FRCOG
• Phone: 00201222150018
• Email: hosamz[@]tedata.net
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The clinical outcome of Ultra-low oxygen tension on post thawed human blastocyst

Description:

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 168
• Est. completion date: June 30, 2020
• Est. primary completion date: June 30, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A to 6 Days

Eligibility

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.

Related Conditions & MeSH terms

• Embryo Development

Intervention

Other:
• 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

Locations

Country	Name	City	State
Egypt	Ganin Fertility Center	Cairo

Sponsors (1)

Lead Sponsor	Collaborator
Ganin Fertility Center

Country where clinical trial is conducted

Egypt, 

References & Publications (8)

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. — View Citation

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. — View Citation

Leese HJ. Human embryo culture: back to nature. J Assist Reprod Genet. 1998 Sep;15(8):466-8. — View Citation

Morin SJ. Oxygen tension in embryo culture: does a shift to 2% O(2) 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. Review. — View Citation

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. Review. — View Citation

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. — View Citation

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. Review. Erratum in: Fertil Steril. 2016 May;105(5):1377. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Secondary	Ongoing pregnancy rate	Defined as the proportion of pregnancies that had completed =20 weeks of gestation	Time frame: 20 weeks of gestation