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

Primary Purpose

Embryo Hypoxia

Status

Unknown status

Phase

Not Applicable

Locations

China

Study Type

Interventional

Intervention

5% oxygen concentration

About this trial

This is an interventional treatment trial for Embryo Hypoxia focused on measuring low oxygen tension, embryo quality

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)FemaleDoes not accept 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)

Sites / Locations

Maternal and Child Health Care HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

5% oxygen

20% oxygen

Arm Description

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

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

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Full Information

NCT ID

NCT01983696

First Posted

November 7, 2013

Last Updated

November 25, 2013

Sponsor

Shanxi Provincial Maternity and Children's Hospital

1. Study Identification

Unique Protocol Identification Number

NCT01983696

Brief Title

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

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

November 2013

Overall Recruitment Status

Unknown status

Study Start Date

November 2013 (undefined)

Primary Completion Date

March 2014 (Anticipated)

Study Completion Date

October 2014 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Shanxi Provincial Maternity and Children's Hospital

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Embryo Hypoxia

Keywords

low oxygen tension, embryo quality

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Non-Randomized

Enrollment

100 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

5% oxygen

Arm Type

Experimental

Arm Description

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

Arm Title

20% oxygen

Arm Type

No Intervention

Arm Description

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

Intervention Type

Other

Intervention Name(s)

5% oxygen concentration

Other Intervention Name(s)

low oxygen concentration

Intervention Description

the oocytes and embryos are cultured in the incubator with concentrations of 6% CO2,5%O2, and 89% N2

Primary Outcome Measure Information:

Title

embryo quality

Description

Time Frame

up to 6 days after fertilization

10. Eligibility

Sex

Female

Accepts Healthy Volunteers

Eligibility Criteria

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)

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Juanzi Shi, Doctor

Phone

+86-029-87219120

shijuanzi123@126.com

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Wenhao Shi, Master

Organizational Affiliation

Maternal and Children Health Care Hospital

Official's Role

Study Director

Facility Information:

Facility Name

Maternal and Child Health Care Hospital

City

Xi'an

State/Province

Shaanxi

ZIP/Postal Code

710003

Country

China

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Wenhao Shi, Master

Phone

+86-02987219120

swihao@yahoo.com

12. IPD Sharing Statement

Learn more about this trial

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

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