the Application of Time-lapes System in IVF/ICSINCT02974517
The Application of Time-lapse System in IVF/ICSI
An observational study of the Application of Time-lapes System in IVF/ICSI, run by The First Affiliated Hospital of Zhengzhou University at 1 site in China.
Trial summary
Nowadays, the rapid development of human assisted reproductive technology (ART) has provided many help for couples with fertility issues. Even take baby home rate has been increased dramatically in the past several decades; both clinicians and embryologists are still struggling to improve pregnancy rates. Read more about this study
- Who is it for?
- Ages 22 to 38 years, women only
- Conditions the study is for
- the Application of Time-lapes System in IVF/ICSI
- What is being tested?
- EmbryoScope®
- Type of treatment
- Medical device
- How many people
- 300 participants
- Where
- 1 siteChina
- Study dates
- Nov 2016to Nov 2018
- 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 22 to 38 years
- Women only
- No healthy volunteers
- Adult
Study population: All embyros are from women undergoing IVF/ICSI in our center.
Who may be able to join
- First IVF/ICSI cycle;
- With normal ovarian reserve(FSH < 10 mIU/mL; antral follicle count>5);
- Age under 38 years old;
- With normal uterine;
- Tubal factor infertility
Who cannot join
- Pre-implantation genetic diagnosis cycles;
- Oocyte donation or sperm donation cycles.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Reproductive Medical Center, 1st Affiliated Hospital of Zhengzhou University
Zhengzhou, Henan, 450052
Haixia Jin, M.D, 86-13523488589, jhxgl@126.com
About this study
Official title: The Application of Time-lapse System in IVF/ICSI: Can it be Beneficial to Final Pregnancy Outcome?
Nowadays, the rapid development of human assisted reproductive technology (ART) has provided many help for couples with fertility issues. Even take baby home rate has been increased dramatically in the past several decades; both clinicians and embryologists are still struggling to improve pregnancy rates. Among all the strategies that the embryologists have tried, much work has been done to find better embryo culture conditions and embryo quality evaluation system. Currently, most centers in the world, including ours, are still using conventional incubators and manual embryo scoring system. This traditional method has several limitations, such as unstable environment during culture, and embryo scores can be different judged by different embryologists. EmbryoScope® by Vitrolife is a newly developed time-lapse embryo culture and analysis system. It is user-friendly, and suited for routinely daily use. In addition, its KID Score system can help embryologist select high quality embryos quickly, which leads to an overall increase in pregnancy outcome in IVF/ICSI cycles. The aim of this prospective cohort study is to evaluate the use of EmbryoScope® in our center.
Read the detailed description
All patients included into this study are divided into three groups:
- Time-lapse-Auto: All embryos are cultured in EmbryoScope®; embryo scores are evaluated on day 3 by KID Score system.
- Time-lapse-Manual: All embryos are cultured in EmbryoScope®; embryo scores are evaluated on day 3 by embryologist.
- Conventional Group: All embryos are cultured in our daily used incubators; embryo scores are evaluated on day 3 by embryologist.
The aim is to compare IVF/ICSI outcomes, such as pregnancy outcome, fertilization rate, cleavage rate, high quality embryo rate, blastocyst formation rate, among these three groups.
- Being tested
- EmbryoScope®
- Keywords
- time-lapes, IVF/ICSI, pregnancy outcome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
EmbryoScope®Device
The intervention is EmbryoScope® versus conventional incubators.
| Study group | Role | What they receive |
|---|---|---|
| Time-lapse-Auto | All embryos are cultured in EmbryoScope®; embryo scores are evaluated on day 3 by KID Score system. Receives: Device: EmbryoScope® | |
| Time-lapse-Manual | All embryos are cultured in EmbryoScope®; embryo scores are evaluated on day 3 by embryologist. Receives: Device: EmbryoScope® | |
| Conventional Group | All embryos are cultured in our daily used incubators; embryo scores are evaluated on day 3 by embryologist. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Clinical pregnancy rate
5 weeks after embryo transfer, gestational sac with fetal heart present inside uterus
Measured: 5 weeks after embryo transfer
Secondary outcomes (3)
2 pronucleus (2PN) fertilization rate
Number of 2PN/Matured oocytes
Measured: 48 hours after oocyte retrieved day
Blastocyst formation rate
Number of Blastocysts/Number of day 3 embryos cultured to blastocyst
Measured: 6 days after oocyte retrieved day
High quality embryo rate
High quality embryos that deserve to be transferred or cryopreserved/ Clevaged embryos in total
Measured: 72 hours after oocyte retrieved day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Nov 2016 (estimated)
- Study startNov 2016
- Primary completionNov 2018 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for the Application of Time-lapes System in IVF/ICSIStudies of the same condition, open and under way.
- More trials run by The First Affiliated Hospital of Zhengzhou UniversityThe sponsor's other registered studies.
- 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
- Prospective
- Enrolment
- 300 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Yingpu Sun, The First Affiliated Hospital of Zhengzhou University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02974517
- Sponsor's protocol ID
- RMCZZU Time-lapse
- Status last verified
- Nov 2016
- First submitted
- 23 Nov 2016
- Last updated
- 28 Nov 2016
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Publications
Wu YG, Lazzaroni-Tealdi E, Wang Q, Zhang L, Barad DH, Kushnir VA, Darmon SK, Albertini DF, Gleicher N. Different effectiveness of closed embryo culture system with time-lapse imaging (EmbryoScope(TM)) in comparison to standard manual embryology in good and poor prognosis patients: a prospectively randomized pilot study. Reprod Biol Endocrinol. 2016 Aug 24;14(1):49. doi: 10.1186/s12958-016-0181-x.
PubMed 27553622Lazzaroni-Tealdi E, Barad DH, Albertini DF, Yu Y, Kushnir VA, Russell H, Wu YG, Gleicher N. Oocyte Scoring Enhances Embryo-Scoring in Predicting Pregnancy Chances with IVF Where It Counts Most. PLoS One. 2015 Dec 2;10(12):e0143632. doi: 10.1371/journal.pone.0143632. eCollection 2015.
PubMed 26630267
Study at a glance
From the registry record, last updated by the sponsor on 28 Nov 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Application of Time-lapse System in IVF/ICSI: Can it be Beneficial to Final Pregnancy Outcome?
- ClinicalTrials.gov ID
- NCT02974517
- Acronym / sponsor ID
- RMCZZU Time-lapse
- Keywords
- time-lapes, IVF/ICSI, pregnancy outcome
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 300 participants (estimated)
- Lead sponsor
- The First Affiliated Hospital of Zhengzhou UniversityUniversity, hospital or other
- Study start
- Nov 2016
- Primary completion
- Nov 2018 (estimated)
- First posted
- 28 Nov 2016 (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.
Nowadays, the rapid development of human assisted reproductive technology (ART) has provided many help for couples with fertility issues. Even take baby home rate has been increased dramatically in the past several decades; both clinicians and embryologists are still struggling to improve pregnancy rates. Among all the strategies that the embryologists have tried, much work has been done to find better embryo culture conditions and embryo quality evaluation system. Currently, most centers in the world, including ours, are still using conventional incubators and manual embryo scoring system. This traditional method has several limitations, such as unstable environment during culture, and embryo scores can be different judged by different embryologists. EmbryoScope® by Vitrolife is a newly developed time-lapse embryo culture and analysis system. It is user-friendly, and suited for routinely daily use. In addition, its KID Score system can help embryologist select high quality embryos quickly, which leads to an overall increase in pregnancy outcome in IVF/ICSI cycles. The aim of this prospective cohort study is to evaluate the use of EmbryoScope® in our center.
Detailed description
All patients included into this study are divided into three groups:
- Time-lapse-Auto: All embryos are cultured in EmbryoScope®; embryo scores are evaluated on day 3 by KID Score system.
- Time-lapse-Manual: All embryos are cultured in EmbryoScope®; embryo scores are evaluated on day 3 by embryologist.
- Conventional Group: All embryos are cultured in our daily used incubators; embryo scores are evaluated on day 3 by embryologist.
The aim is to compare IVF/ICSI outcomes, such as pregnancy outcome, fertilization rate, cleavage rate, high quality embryo rate, blastocyst formation rate, among these three groups.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Time-lapse-Auto | – | Device: EmbryoScope®All embryos are cultured in EmbryoScope®; embryo scores are evaluated on day 3 by KID Score system. |
| Time-lapse-Manual | – | Device: EmbryoScope®All embryos are cultured in EmbryoScope®; embryo scores are evaluated on day 3 by embryologist. |
| Conventional Group | – | –All embryos are cultured in our daily used incubators; embryo scores are evaluated on day 3 by embryologist. |
Who may qualify
- Ages
- 22 to 38 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
- Study population
- All embyros are from women undergoing IVF/ICSI in our center.
Key inclusion criteria (5 listed)
- First IVF/ICSI cycle;
- With normal ovarian reserve(FSH < 10 mIU/mL; antral follicle count>5);
- Age under 38 years old;
- With normal uterine;
- Tubal factor infertility
Key exclusion criteria (2 listed)
- Pre-implantation genetic diagnosis cycles;
- Oocyte donation or sperm donation cycles.
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 |
|---|---|---|
| EmbryoScope®The intervention is EmbryoScope® versus conventional incubators. | Device | Time-lapse-Auto, Time-lapse-Manual |
Primary outcome
Clinical pregnancy rate
Time frame: 5 weeks after embryo transfer
5 weeks after embryo transfer, gestational sac with fetal heart present inside uterus
3 secondary outcomes
2 pronucleus (2PN) fertilization rate
Time frame: 48 hours after oocyte retrieved day
Blastocyst formation rate
Time frame: 6 days after oocyte retrieved day
High quality embryo rate
Time frame: 72 hours after oocyte retrieved day
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Nov 2016.
- Background: PubMed 27553622Wu YG, Lazzaroni-Tealdi E, Wang Q, Zhang L, Barad DH, Kushnir VA, Darmon SK, Albertini DF, Gleicher N. Different effectiveness of closed embryo culture system with time-lapse imaging (EmbryoScope(TM)) in comparison to standard manual embryology in good and poor prognosis patients: a prospectively randomized pilot study. Reprod Biol Endocrinol. 2016 Aug 24;14(1):49. doi: 10.1186/s12958-016-0181-x.
- Background: PubMed 26630267Lazzaroni-Tealdi E, Barad DH, Albertini DF, Yu Y, Kushnir VA, Russell H, Wu YG, Gleicher N. Oocyte Scoring Enhances Embryo-Scoring in Predicting Pregnancy Chances with IVF Where It Counts Most. PLoS One. 2015 Dec 2;10(12):e0143632. doi: 10.1371/journal.pone.0143632. eCollection 2015.
- Individual participant dataSharing planned: No
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.
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 the Application of Time-lapes System in IVF/ICSI, run by The First Affiliated Hospital of Zhengzhou 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 5 inclusion and 2 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 28 Nov 2016. 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 Haixia Jin, M.D. (86-13523488589, jhxgl@126.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Clinical pregnancy rate (time frame: 5 weeks after embryo transfer). 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 NCT02974517, which also lists 2 linked publications.
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 28 Nov 2016.