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

NCT ID: NCT01983696

Last Updated: 2013-11-27

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

100 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-11-30

Study Completion Date

2014-10-31

Brief Summary

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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

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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.

Conditions

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Embryo Hypoxia

Keywords

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low oxygen tension embryo quality

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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5% oxygen

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

Group Type EXPERIMENTAL

5% oxygen concentration

Intervention Type OTHER

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

20% oxygen

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

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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5% oxygen concentration

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

Intervention Type OTHER

Other Intervention Names

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low oxygen concentration

Eligibility Criteria

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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)
Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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Shanxi Provincial Maternity and Children's Hospital

OTHER

Sponsor Role lead

Responsible Party

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Shi Wenhao

Assisted Reproductive Technology Center

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Wenhao Shi, Master

Role: STUDY_DIRECTOR

Maternal and Children Health Care Hospital

Locations

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Maternal and Child Health Care Hospital

Xi'an, Shaanxi, China

Site Status RECRUITING

Countries

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China

Central Contacts

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Juanzi Shi, Doctor

Role: CONTACT

Phone: +86-029-87219120

Email: [email protected]

Facility Contacts

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Wenhao Shi, Master

Role: primary

Other Identifiers

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MCHC-2013-02

Identifier Type: -

Identifier Source: org_study_id