InfertilityAvailabilityNCT01715545
Availability of Poor Quality Embryos
An observational study of Infertility, run by The Second Affiliated Hospital of Kunming Medical University at 1 site in China.
Trial summary
The purpose of this study is to explore a method to identify the viability of day-3 poor quality embryos Read more about this study
- Who is it for?
- Ages 20 to 40 years, women only
- Conditions the study is for
- Infertility
- How many people
- 481 participants
- Where
- 1 siteChina
- Study dates
- Jan 2011to Oct 2012
- Phase
- Observational
- 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 20 to 40 years
- Women only
- No healthy volunteers
- Adult
Study population: unfertile women
Who may be able to join
- unfertile women
Who cannot join
- women older than 40 years
Trial locations and contacts
1 site in 1 country.
China1 site
The Second Affiliated Hospital of Kunming Medical University
Kunming, Yunnan, 650101
About this study
Official title: Availability of Poor Quality Embryos in Frozen-thawed Embryo Transfer Cycles
The purpose of this study is to explore a method to identify the viability of day-3 poor quality embryos
Read the detailed description
Day-3 poor quality embryos are related to significant lower clinical pregnancy,so freezing numerous poor quality embryos are clinical impractical. To ensure the successful pregnancy and to enhance the availability of the poor quality embryos, day-3 poor quality embryos are further cultured to different developmental stage and then cryopreserved. The viability of these embryos are tested in frozen-thawed transfer.
- Conditions
- Infertility
- Keywords
- day-3 poor quality embryo, vitrification, clinical outcome
- Medical subject headings
- Infertility
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| day-3 poor quality embryos | Not described | |
| developmental stage | day3 poor quality embryos day4 morular day-5/6 blastocyst |
What is being measured
The primary outcome is the main question the study is designed to answer.
pregnancy rate
Measured: 5 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Oct 2012 (estimated)
- Study startJan 2011
- Primary completionApr 2012
- Study completionOct 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for InfertilityStudies 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
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 481 participants (actual)
Sponsor and investigators
- Lead sponsor
- The Second Affiliated Hospital of Kunming Medical University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Yang Jie, The Second Affiliated Hospital of Kunming Medical University
- Investigators
- Jie Yang, Principal investigator, The Second Affiliated Hospital of Kunming Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01715545
- Sponsor's protocol ID
- 200601YJ
- Acronym
- Availability
- Status last verified
- Oct 2012
- First submitted
- 24 Oct 2012
- Last updated
- 29 Oct 2012
- Results posted
- No
- Data monitoring committee
- No
Publications
(1) Lu LI, Xiao-xi SUN, Jun-ling CHEN, et al. Analysis of Factors Influencing Pregnancy Rate in Frozen-thawed Embryo Transfer. Journal of Reproduction and Contraception (2004) 15 (4):239-244
Study at a glance
From the registry record, last updated by the sponsor on 29 Oct 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Availability of Poor Quality Embryos in Frozen-thawed Embryo Transfer Cycles
- ClinicalTrials.gov ID
- NCT01715545
- Acronym / sponsor ID
- Availability / 200601YJ
- Conditions
- Infertility
- Keywords
- day-3 poor quality embryo, vitrification, clinical outcome
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 481 participants (actual)
- Lead sponsor
- The Second Affiliated Hospital of Kunming Medical UniversityUniversity, hospital or other
- Study start
- Jan 2011
- Primary completion
- Apr 2012 (actual)
- Study completion
- Oct 2012 (actual)
- First posted
- 29 Oct 2012 (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.
The purpose of this study is to explore a method to identify the viability of day-3 poor quality embryos
Detailed description
Day-3 poor quality embryos are related to significant lower clinical pregnancy,so freezing numerous poor quality embryos are clinical impractical. To ensure the successful pregnancy and to enhance the availability of the poor quality embryos, day-3 poor quality embryos are further cultured to different developmental stage and then cryopreserved. The viability of these embryos are tested in frozen-thawed transfer.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| day-3 poor quality embryos | – | – |
| developmental stage | – | –day3 poor quality embryos day4 morular day-5/6 blastocyst |
Who may qualify
- Ages
- 20 to 40 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
- Study population
- unfertile women
Key inclusion criteria (1 listed)
- unfertile women
Key exclusion criteria (1 listed)
- women older than 40 years
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
pregnancy rate
Time frame: 5 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Oct 2012.
- Background(1) Lu LI, Xiao-xi SUN, Jun-ling CHEN, et al. Analysis of Factors Influencing Pregnancy Rate in Frozen-thawed Embryo Transfer. Journal of Reproduction and Contraception (2004) 15 (4):239-244
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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.
Jie Yang principal investigator
The Second Affiliated Hospital of Kunming Medical University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Infertility, run by The Second Affiliated Hospital of Kunming Medical University 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 1 inclusion and 1 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: finished, as of the sponsor's last update on 29 Oct 2012. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
pregnancy rate (time frame: 5 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01715545, which also lists 1 linked publication.
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 29 Oct 2012.