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

Embryo Hypoxia Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01983696
• Other study ID #: MCHC-2013-02
• Status: Recruiting
• Phase: N/A
• First received: November 7, 2013
• Last updated: November 25, 2013
• Start date: November 2013
• Est. completion date: October 2014

Study information

• Verified date: November 2013
• Source: Shanxi Provincial Maternity and Children's Hospital
• Contact: Juanzi Shi, Doctor
• Phone: +86-029-87219120
• Email: shijuanzi123[@]126.com
• Is FDA regulated: No
• Health authority: China: State Administration of Traditional Chinese Medicine of the People's Republic of ChinaUnited States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 100
• Est. completion date: October 2014
• Est. primary completion date: March 2014
• Accepts healthy volunteers: No
• Gender: Female
• Age group: N/A and older

Eligibility

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

Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Embryo Hypoxia

Intervention

Other:
• 5% oxygen concentration
the oocytes and embryos are cultured in the incubator with concentrations of 6% CO2,5%O2, and 89% N2

Locations

Country	Name	City	State
China	Maternal and Child Health Care Hospital	Xi'an	Shaanxi

Sponsors (1)

Lead Sponsor	Collaborator
Shanxi Provincial Maternity and Children's Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Yes