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

Ganin Fertility Center

Status: Unknown

Conditions: Embryo Development

Treatments: Other: 5% O2; Other: 2% O2

Study type: Interventional

Funder types: Other

Identifiers

NCT03817671

GFCST11991

Details and patient eligibility

About

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

Full 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.

Enrollment: 168 estimated patients

Sex: All

Ages: 5 to 6 days old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Other

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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168 participants in 2 patient groups

Control arm (5% O2)

Other group

Description:

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

Treatment:

Other: 5% O2

Experimental arm (2%O2)

Experimental group

Description:

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

Treatment:

Other: 2% O2