NCT01983696

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

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
100

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Nov 2013

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 1, 2013

Completed
6 days until next milestone

First Submitted

Initial submission to the registry

November 7, 2013

Completed
7 days until next milestone

First Posted

Study publicly available on registry

November 14, 2013

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2014

Completed
7 months until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2014

Completed
Last Updated

November 27, 2013

Status Verified

November 1, 2013

Enrollment Period

4 months

First QC Date

November 7, 2013

Last Update Submit

November 25, 2013

Conditions

Embryo Hypoxia

Keywords

low oxygen tensionembryo quality

Outcome Measures

Primary Outcomes (1)

  • 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

Study Arms (2)

5% oxygen

EXPERIMENTAL

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

Other: 5% oxygen concentration

20% oxygen

NO INTERVENTION

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

Interventions

5% oxygen concentrationOTHER

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

Also known as: low oxygen concentration
5% oxygen

Eligibility Criteria

Sexfemale
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • Fresh cycles of in vitro fertilization/intracytoplasmic sperm injection and emrbyo transfer (IVF/ICSI-ET)
  • ≥ 10 oocytes after oocyte retrieval

You may not qualify if:

  • ≥ 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)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Maternal and Child Health Care Hospital

Xi'an, Shaanxi, 710003, China

RECRUITING

Study Officials

  • Wenhao Shi, Master

    Maternal and Children Health Care Hospital

    STUDY DIRECTOR

Central Study Contacts

Juanzi Shi, Doctor

CONTACT

+86-029-87219120shijuanzi123@126.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assisted Reproductive Technology Center

Study Record Dates

First Submitted

November 7, 2013

First Posted

November 14, 2013

Study Start

November 1, 2013

Primary Completion

March 1, 2014

Study Completion

October 1, 2014

Last Updated

November 27, 2013

Record last verified: 2013-11

Locations

CN(1)