Embryo CultureNCT03464643
A Prospective Study Comparing the Outcomes of Single Versus Group Culture in Preimplantation Genetic Testing Cycles
A study testing embryo culture in people with Embryo Culture, run by Reproductive & Genetic Hospital of CITIC-Xiangya at 1 site in China.
Trial summary
The aim of this study is to analyze whether there is difference in the effect of single embryo culture and group culture in preimplantation genetic screening (PGS) cycle, and provide reference for the feasibility of the clinical application of medium-based noninvasive PGD. Read more about this study
- Who is it for?
- Ages 20 to 45 years, women only
- Conditions the study is for
- Embryo Culture
- What is being tested?
- embryo culture
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 236 participants
- Where
- 1 siteChina
- Study dates
- 23 Oct 2017to 23 Sep 2019
- 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 20 to 45 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- patients treated by preimplantation genetic diagnostic / screening cycles
Who cannot join
- number of normal fertilization zygotes is less than 6
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Reproductive and Genetic Hospital of Citic-xiangya
Changsha, Hunan, 410000
Xiaojuan Wang, Doc, +86-731-82355100, 646829625@qq.com
About this study
Official title: A Prospective Study Comparing the Outcomes of Single Embryo Culture Versus Group Culture in Preimplantation Genetic Testing Cycles
The aim of this study is to analyze whether there is difference in the effect of single embryo culture and group culture in preimplantation genetic screening (PGS) cycle, and provide reference for the feasibility of the clinical application of medium-based noninvasive PGD. This prospective study prepares for more than 1,000 normal fertilized zygotes in each group over one year period. For the recruited patients, all normal fertilized zygotes were randomly allocated into two groups: cultured individually in 25 ul media or 2-3 embryos cultured together in 50 ul media. The blastocyst formation rates, aneuploid rates, clinical pregnancy rates, implantation rates and miscarriage rates will be compared between the two groups.
- Conditions
- Embryo Culture
- Being tested
- embryo culture
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
embryo cultureOther
Single embryo culture means only one embryo is cultured in one drop, and the group culture refers to culture of 2-5 embryos in one drop. The main advantage of group culture may be secreting some paracrine cytokines by embryos and benefit each other; and the possible disadvantage of group culture is that embryo secreting of some harmful substances which accumulated to a certain extent will damage the developmental potential of embryos. The advantages and disadvantages of single embryo culture are contrary to group culture.
| Study group | Role | What they receive |
|---|---|---|
| Single embryo culture | Other | Embryo is cultured individually in 25 ul media Receives: Other: embryo culture |
| Group embryo culture | Other | 2-3 Embryos are group cultured in 50 ul media Receives: Other: embryo culture |
What is being measured
The primary outcome is the main question the study is designed to answer.
high quality blastocyst formation rate
number of blastocysts with high quality divided by number of zygotes with normal fertilization
Measured: 6 days after fertilization
Secondary outcomes (2)
embryo euploid rate
number of euploid blastocysts divided by all blastocysts detected
Measured: about one month after blastocyst biopsy
embryo implantation rate
number of gestational sacs divided by number of embryo transferred
Measured: about three to six months after blastocyst biopsy
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Mar 2018
- Study start23 Oct 2017
- Primary completion23 Jan 2019 (estimated)
- Study completion23 Sep 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Embryo CultureStudies 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
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 236 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Reproductive & Genetic Hospital of CITIC-Xiangya
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Xiaojuan Wang, Doc, Principal investigator, Reproductive and Genetic Hospital of Citic-xiangya
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03464643
- Sponsor's protocol ID
- KYXM-20180307
- Status last verified
- Dec 2018
- First submitted
- 7 Mar 2018
- Last updated
- 10 Dec 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 10 Dec 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective Study Comparing the Outcomes of Single Embryo Culture Versus Group Culture in Preimplantation Genetic Testing Cycles
- ClinicalTrials.gov ID
- NCT03464643
- Acronym / sponsor ID
- KYXM-20180307
- Conditions
- Embryo Culture
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 236 participants (estimated)
- Lead sponsor
- Reproductive & Genetic Hospital of CITIC-XiangyaUniversity, hospital or other
- Study start
- 23 Oct 2017 (actual)
- Primary completion
- 23 Jan 2019 (estimated)
- Study completion
- 23 Sep 2019 (estimated)
- First posted
- 14 Mar 2018 (actual)
- 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 aim of this study is to analyze whether there is difference in the effect of single embryo culture and group culture in preimplantation genetic screening (PGS) cycle, and provide reference for the feasibility of the clinical application of medium-based noninvasive PGD. This prospective study prepares for more than 1,000 normal fertilized zygotes in each group over one year period. For the recruited patients, all normal fertilized zygotes were randomly allocated into two groups: cultured individually in 25 ul media or 2-3 embryos cultured together in 50 ul media. The blastocyst formation rates, aneuploid rates, clinical pregnancy rates, implantation rates and miscarriage rates will be compared between the two groups.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Single embryo culture | Other | Other: embryo cultureEmbryo is cultured individually in 25 ul media |
| Group embryo culture | Other | Other: embryo culture2-3 Embryos are group cultured in 50 ul media |
Who may qualify
- Ages
- 20 to 45 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- patients treated by preimplantation genetic diagnostic / screening cycles
Key exclusion criteria (1 listed)
- number of normal fertilization zygotes is less than 6
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 |
|---|---|---|
| embryo cultureSingle embryo culture means only one embryo is cultured in one drop, and the group culture refers to culture of 2-5 embryos in one drop. The main advantage of group culture may be secreting some paracrine cytokines by embryos and benefit each other; and the possible disadvantage of group culture is that embryo secreting of some harmful substances which accumulated to a certain extent will damage the developmental potential of embryos. The advantages and disadvantages of single embryo culture are contrary to group culture. | Other | Group embryo culture, Single embryo culture |
Primary outcome
high quality blastocyst formation rate
Time frame: 6 days after fertilization
number of blastocysts with high quality divided by number of zygotes with normal fertilization
2 secondary outcomes
embryo euploid rate
Time frame: about one month after blastocyst biopsy
embryo implantation rate
Time frame: about three to six months after blastocyst biopsy
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Dec 2018.
- Individual participant dataSharing planned: Undecided
Related trials for Embryo Culture
Not yet recruiting
Cryopreserved Pre-embryo Transfer in a Cytokine-rich Medium Versus Hyaluronic Acid
Frozen Embryo Transfer (FET)
RecruitingObservational study
Study of Abnormally Fertilized Embryos
Infertility (IVF Patients)
Recruiting
A Multicenter Prospective Randomized Controlled Clinical Trial Comparing Constant (5%) Versus Sequential (5%-2%) Oxygen Concentration Embryo Culture Protocols in Assisted Reproductive Technology
Fertility Issues, Blastocyst IVF
Not yet recruiting
OSC Co-culture for Rescue IVM of Human GV Oocytes
Oocyte Maturation, Infertility
Not yet recruiting
Evaluation of an Undisturbed Embryo Culture System for Embryo Development in IVF/ICSI Cycles
Embryo Culture, Embryo Culture Media
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.
Xiaojuan Wang, Doc principal investigator
Reproductive and Genetic Hospital of Citic-xiangya
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing embryo culture in people with Embryo Culture, run by Reproductive & Genetic Hospital of CITIC-Xiangya 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: status not confirmed, as of the sponsor's last update on 10 Dec 2018. 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 Shuoping Zhang, Doc (+86-731-88395640, baibaipang@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
high quality blastocyst formation rate (time frame: 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 10 Dec 2018.