Embryo HypoxiaNCT01983696
The Effect of Low Oxygen Tension on the Early Development of Human Embryo in IVF/ICSI
A study testing 5% oxygen concentration in people with Embryo Hypoxia, run by Shanxi Provincial Maternity and Children's Hospital at 1 site in China.
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 Read more about this study
- Who is it for?
- Any age, women only
- Conditions the study is for
- Embryo Hypoxia
- What is being tested?
- 5% oxygen concentration
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteChina
- Study dates
- Nov 2013to Oct 2014
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- Women only
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Fresh cycles of in vitro fertilization/intracytoplasmic sperm injection and emrbyo transfer (IVF/ICSI-ET)
- ≥ 10 oocytes after oocyte retrieval
Who cannot join
- ≥ 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)
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Maternal and Child Health Care Hospital
Xi'an, Shaanxi, 710003
Wenhao Shi, Master, +86-02987219120, swihao@yahoo.com
About this study
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
Read the 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.
- Conditions
- Embryo Hypoxia
- Being tested
- 5% oxygen concentration
- Keywords
- low oxygen tension, embryo quality
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
5% oxygen concentrationOther
Also called low oxygen concentration
the oocytes and embryos are cultured in the incubator with concentrations of 6% CO2,5%O2, and 89% N2
| Study group | Role | What they receive |
|---|---|---|
| 5% oxygen | Experimental | the oocytes and embryos are cultured in 5% oxygen concentration after oocytes retrieval until Day 6 (counting from fertilization) Receives: 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) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: up to 6 days after fertilization
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Nov 2013 (estimated)
- Study startNov 2013
- Primary completionMar 2014 (estimated)
- Study completionOct 2014 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Embryo HypoxiaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Shanxi Provincial Maternity and Children's Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Shi Wenhao, Shanxi Provincial Maternity and Children's Hospital
- Investigators
- Wenhao Shi, Master, Study director, Maternal and Children Health Care Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01983696
- Sponsor's protocol ID
- MCHC-2013-02
- Status last verified
- Nov 2013
- First submitted
- 7 Nov 2013
- Last updated
- 27 Nov 2013
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 27 Nov 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Low Oxygen Tension on the Early Development of Human Embryo in IVF/ICSI
- ClinicalTrials.gov ID
- NCT01983696
- Acronym / sponsor ID
- MCHC-2013-02
- Conditions
- Embryo Hypoxia
- Keywords
- low oxygen tension, embryo quality
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Shanxi Provincial Maternity and Children's HospitalUniversity, hospital or other
- Study start
- Nov 2013
- Primary completion
- Mar 2014 (estimated)
- Study completion
- Oct 2014 (estimated)
- First posted
- 14 Nov 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 5% oxygen | Experimental | Other: 5% oxygen concentrationthe oocytes and embryos are cultured in 5% oxygen concentration after oocytes retrieval until Day 6 (counting from fertilization) |
| 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) |
Who may qualify
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (2 listed)
- Fresh cycles of in vitro fertilization/intracytoplasmic sperm injection and emrbyo transfer (IVF/ICSI-ET)
- ≥ 10 oocytes after oocyte retrieval
Key exclusion criteria (6 listed)
- ≥ 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 5% oxygen concentrationAlso: low oxygen concentrationthe oocytes and embryos are cultured in the incubator with concentrations of 6% CO2,5%O2, and 89% N2 | Other | 5% oxygen |
Primary outcome
embryo quality
Time frame: up to 6 days after fertilization
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
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Nov 2013.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Wenhao Shi, Master study director
Maternal and Children Health Care Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing 5% oxygen concentration in people with Embryo Hypoxia, run by Shanxi Provincial Maternity and Children's Hospital at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 27 Nov 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Juanzi Shi, Doctor (+86-029-87219120, shijuanzi123@126.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
embryo quality (time frame: up to 6 days after fertilization). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Nov 2013.