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

Not Applicable

• Conditions: Embryo Hypoxia
• Interventions: Other: 5% oxygen concentration

• Registration Number: NCT01983696
• Lead Sponsor: Shanxi Provincial Maternity and Children's Hospital

Brief Summary

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

Detailed 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.

Study Timeline

• Status Verified: 2013-11
• Study Start: 2013-11
• Study First Submitted: 2013-11-07
• Study First Submitted QC: 2013-11-13
• Study First Posted: 2013-11-14
• Last Update Submitted: 2013-11-25
• Last Update Posted: 2013-11-27
• Primary Completion: 2014-03
• Study Completion: 2014-10

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: Female
• Target Recruitment: 100

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)

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

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

Primary Outcome Measures

Name	Time	Method
embryo quality	up to 6 days after fertilization	Embryo morphology was assessed on day 2, day 3 day 4 day 5 day and 6 by considering the number of blastomeres, symmetry and granularity of blastomeres, type and percentage of fragmentation, presence of multinucleated blastomeres, and degree of compaction.; Gardner's blastocyst scoring system is used for blastocyst assessment

Trial Locations

Locations (1)

Maternal and Child Health Care Hospital; 🇨🇳 Xi'an, Shaanxi, China