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

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

Study Overview

• Status: Unknown
• Conditions: Embryo Hypoxia
• Intervention / Treatment: Other: 5% oxygen concentration

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 Type: Interventional
• Enrollment (Anticipated): 100
• Phase: Not Applicable

Contacts and Locations

Study Locations

• China
  • Shaanxi
    • Xi'an, Shaanxi, China, 710003
      • Recruiting
      • Maternal and Child Health Care Hospital
      • Contact: Wenhao Shi, Master; Phone Number: +86-02987219120; Email: swihao@yahoo.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: ADULT; OLDER_ADULT; CHILD
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: NON_RANDOMIZED
• Interventional Model: PARALLEL
• Masking: NONE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: 5% oxygen; the oocytes and embryos are cultured in 5% oxygen concentration after oocytes retrieval until Day 6 (counting from fertilization)	Other: 5% oxygen concentration; the oocytes and embryos are cultured in the incubator with concentrations of 6% CO2,5%O2, and 89% N2; Other Names: low oxygen concentration
NO_INTERVENTION: 20% oxygen; the oocytes and embryos are cultured in 20% oxygen concentration (in atmosphere) after oocytes retrieval until Day 6(counting from fertilization)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
embryo quality	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	up to 6 days after fertilization

Collaborators and Investigators

• Sponsor: Shanxi Provincial Maternity and Children's Hospital

Study record dates

Study Major Dates

• Study Start: November 1, 2013
• Primary Completion (ANTICIPATED): March 1, 2014
• Study Completion (ANTICIPATED): October 1, 2014

Study Registration Dates

• First Submitted: November 7, 2013
• First Submitted That Met QC Criteria: November 13, 2013
• First Posted (ESTIMATE): November 14, 2013

Study Record Updates

• Last Update Posted (ESTIMATE): November 27, 2013
• Last Update Submitted That Met QC Criteria: November 25, 2013
• Last Verified: November 1, 2013

More Information

Terms related to this study

• Keywords: embryo quality; low oxygen tension
• Additional Relevant MeSH Terms: Signs and Symptoms, Respiratory; Hypoxia
• Other Study ID Numbers: MCHC-2013-02