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

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

Status
UNKNOWN
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03817671
Enrollment
168
Registered
2019-01-25
Start date
2018-11-20
Completion date
2020-06-30
Last updated
2019-01-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Embryo Development

Keywords

Thawed blastocyst, ultra low oxygen tension, 2%O2, Degree of expansion

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.

Interventions

OTHER5% O2

Culturing embryos in 5% O2 just after thawing and till embryo transfer

OTHER2% O2

Culturing embryos in 2% O2 just after thawing and till embryo transfer

Sponsors

Ganin Fertility Center
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
5 Days to 6 Days
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frameDescription
Clinical Pregnancy rateTime frame: 15 days following embryo transferDefined as the pregnancy that is confirmed by both high levels of hCG and ultrasound confirmation of a gestational sac or heartbeat

Secondary

MeasureTime frameDescription
Ongoing pregnancy rateTime frame: 20 weeks of gestationDefined as the proportion of pregnancies that had completed ≥20 weeks of gestation

Countries

Egypt

Contacts

Primary ContactHosam Zaki, MSc, FRCOG
hosamz@tedata.net00201222150018
Backup ContactSalma El Tanbouly, BSc.
salmaeltanbouly@gmail.com00201279655807

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026