Clinical trial NCT03817671: The Clinical Outcome of Ultra-low Oxygen Tension on Post Thawed Human Blastocyst
Official title: The Clinical Outcome of Ultra-low Oxygen Tension on Post Thawed Human Blastocyst
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Embryo Development
Keywords: Thawed blastocyst
ultra low oxygen tension
2%O2
Degree of expansion
Lead sponsor: Ganin Fertility Center
Sponsor class: OTHER
First posted: 2019-01-25
Enrollment: 168
Sex: ALL
Minimum age (years): 5
Maximum age (years): 6
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

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

Detailed 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.

Eligibility criteria: 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.

Primary outcomes:
measure: Clinical Pregnancy rate
timeFrame: Time frame: 15 days following embryo transfer
Secondary outcomes:
measure: Ongoing pregnancy rate
timeFrame: Time frame: 20 weeks of gestation
Other outcomes:
Locations:
city: Cairo
country: Egypt
facility: Ganin Fertility Center
Study officials:
affiliation: Ganin Fertility Center, Cairo, Egypt.
name: Hosam Zaki, MSc, FRCOG
role: STUDY_CHAIR
affiliation: Ganin Fertility Center, Cairo, Egypt.
name: Salma El Tanbouly, BSc.
role: PRINCIPAL_INVESTIGATOR
affiliation: Ganin Fertility Center, Cairo, Egypt.
name: Abd El Ghafar Hussin, BSc.
role: PRINCIPAL_INVESTIGATOR
affiliation: Ganin Fertility Center, Cairo, Egypt.
name: Hanaa El Khedr
role: PRINCIPAL_INVESTIGATOR
References:
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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.
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