The Effect of Low Oxygen Tension on the Early Development of Human Embryo in IVF/ICSI

Shanxi Provincial Maternity and Child Health Hospital

Status: Unknown

Conditions: Embryo Hypoxia

Treatments: Other: 5% oxygen concentration

Study type: Interventional

Funder types: Other

Identifiers

NCT01983696

MCHC-2013-02

Details and patient eligibility

About

To investigate the effect of low oxygen tension during in vitro culture in terms of embryo quality and outcomes of pregnancy in vitro fertilization/ Intracytoplasmic sperm injection

Full description

The oocytes will be divided into two parts(two groups) form one patient. The two groups of oocytes will be cultured seperately in the incubator with the concentrations of 5% CO2,6%O2,89% N2(low oxygen concentration) verse 6% CO2,20% O2,74% N2(in atmosphere).

A series of observational measurement(embryo quality and outcomes of pregnancy) will be performed.

Enrollment: 100 estimated patients

Sex: Female

Volunteers: No Healthy Volunteers

Inclusion criteria

• Fresh cycles of in vitro fertilization/intracytoplasmic sperm injection and emrbyo transfer (IVF/ICSI-ET)
• ≥ 10 oocytes after oocyte retrieval

Exclusion criteria

• ≥ 3 transfer or oocyte retrieval cycles
• PGD/PGS cycles
• half-ICSI/rescure ICSI
• fluid in the uterine cavity, abnormal endometrium, uterine abnormalities,pelvic inflammation
• acute maternal problems.
• One or both spouses have an abnormal karyotype (including polymorphism)

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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100 participants in 2 patient groups

5% oxygen

Experimental group

Description:

the oocytes and embryos are cultured in 5% oxygen concentration after oocytes retrieval until Day 6 (counting from fertilization)

Treatment:

Other: 5% oxygen concentration

20% oxygen

No Intervention group

Description:

the oocytes and embryos are cultured in 20% oxygen concentration (in atmosphere) after oocytes retrieval until Day 6(counting from fertilization)