Other Complications Associated With Artificial FertilizationGroupCultureNCT01774006
Comparison of Individual Culture and Group Culture of Preimplantation Embryos in Human IVF Treatments
An observational study of Other Complications Associated With Artificial Fertilization, run by Semmelweis University at 1 site in Hungary.
Trial summary
Prospective randomized comparison of two widely used in vitro culture system in human IVF treatments. In vitro fertilized oocytes and embryos are cultured in individual culture media droplets using conventional petridish or in group culture using WOW (well of the well) petridish. Read more about this study
- Who is it for?
- Ages 18 to 45 years, women only
- Conditions the study is for
- Other Complications Associated With Artificial Fertilization
- What is being tested?
- individual embryo culture or group culture
- How many people
- 532 participants
- Where
- 1 siteHungary
- Study dates
- Sep 2012to Sep 2015
- 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 18 to 45 years
- Women only
- No healthy volunteers
- Adult
Study population: Patients entering in vitro fertilization and embryo transfer treatment
Who may be able to join
- Infertile patients entering in vitro fertilization treatment
- at least 1 oocyte collected
Who cannot join
- no oocytes collected
Trial locations and contacts
1 site in 1 country.
Hungary1 site
Semmelweis University First Department of Obstetrics and Gynecology
Budapest, 1088
About this study
Prospective randomized comparison of two widely used in vitro culture system in human IVF treatments. In vitro fertilized oocytes and embryos are cultured in individual culture media droplets using conventional petridish or in group culture using WOW (well of the well) petridish.
Primary outcome: implantation and pregnancy rates Secondary outcome: fertilization rate and embryo quality
- Being tested
- individual embryo culture or group culture
- Keywords
- In vitro fertilization, Embryo transfer, Embryo culture, individual culture, Group culture, embryo quality, Pregnancy rate, Implantation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
individual embryo culture or group cultureOther
Embryos cultured in a 25 microliter droplet of culture media individually in a conventional petridish or in groups of 2-10 embryos in a Well-of-the-Well petridish
| Study group | Role | What they receive |
|---|---|---|
| Group culture | Embryos cultured in groups of 2-10 Receives: Other: individual embryo culture or group culture | |
| Individual culture | Embryos cultured individually Receives: Other: individual embryo culture or group culture |
What is being measured
The primary outcome is the main question the study is designed to answer.
Clinical pregnancy rate
Number of clinical pregnancies (/No. of embryo transfers)
Measured: 4 weeks after the embryo transfer
Implantation rate
Number of embryos implanted (/number of embryos transferred)
Measured: 4 weeks after embryo transfer
Secondary outcomes (2)
Fertilization rate
Number of oocytes fertilized. (only in intracytoplasmic sperm injection cycles)
Measured: 18 hours after sperm injection
Embryo quality
Number and quality of blastomeres, amount of fragmentation embryo grade
Measured: 36 and 72 hours after fertilization
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jan 2013 (estimated)
- Study startSep 2012
- Primary completionMay 2015
- Study completionSep 2015
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 Other Complications Associated With Artificial FertilizationStudies of the same condition, open and under way.
- More trials run by Semmelweis 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
- 532 participants (actual)
Sponsor and investigators
- Lead sponsor
- Semmelweis University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Peter Fancsovits, Ph.D., Semmelweis University
- Investigators
- Janos Urbancsek, DSc, Principal investigator, Semmelweis University First Department of Obstetrics and GynecologyPeter Fancsovits, Ph.D., Study chair, Semmelweis University First Department of Obstetrics and GynecologyCsaba Pribenszky, Ph.D., Principal investigator, University of Veterinary Sciences, BudapestAdam Lehner, MSc, Principal investigator, Semmelweis University First Department of Obstetrics and Gynecology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01774006
- Sponsor's protocol ID
- SemmelweisU-001
- Acronym
- GroupCulture
- Status last verified
- Sep 2015
- First submitted
- 18 Jan 2013
- Last updated
- 2 Sep 2015
- Results posted
- No
- Data monitoring committee
- No
Publications
Fancsovits P, Pribenszky C, Lehner A, Murber A, Kaszas Z, Nemes A, Urbancsek J. Prospective-randomized study comparing clinical outcomes of IVF treatments where embryos were cultured individually or in a microwell group culture dish. Biol Futur. 2022 Jun;73(2):229-236. doi: 10.1007/s42977-022-00113-8. Epub 2022 Mar 12.
PubMed 35278201
Study at a glance
From the registry record, last updated by the sponsor on 2 Sep 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Individual Culture and Group Culture of Preimplantation Embryos in Human IVF Treatments
- ClinicalTrials.gov ID
- NCT01774006
- Acronym / sponsor ID
- GroupCulture / SemmelweisU-001
- Keywords
- In vitro fertilization, Embryo transfer, Embryo culture, individual culture, Group culture, embryo quality, Pregnancy rate, Implantation
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 532 participants (actual)
- Lead sponsor
- Semmelweis UniversityUniversity, hospital or other
- Study start
- Sep 2012
- Primary completion
- May 2015 (actual)
- Study completion
- Sep 2015 (actual)
- First posted
- 23 Jan 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.
Prospective randomized comparison of two widely used in vitro culture system in human IVF treatments. In vitro fertilized oocytes and embryos are cultured in individual culture media droplets using conventional petridish or in group culture using WOW (well of the well) petridish.
Primary outcome: implantation and pregnancy rates Secondary outcome: fertilization rate and embryo quality
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group culture | – | Other: individual embryo culture or group cultureEmbryos cultured in groups of 2-10 |
| Individual culture | – | Other: individual embryo culture or group cultureEmbryos cultured individually |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
- Study population
- Patients entering in vitro fertilization and embryo transfer treatment
Key inclusion criteria (2 listed)
- Infertile patients entering in vitro fertilization treatment
- at least 1 oocyte collected
Key exclusion criteria (1 listed)
- no oocytes collected
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 |
|---|---|---|
| individual embryo culture or group cultureEmbryos cultured in a 25 microliter droplet of culture media individually in a conventional petridish or in groups of 2-10 embryos in a Well-of-the-Well petridish | Other | Group culture, Individual culture |
Primary outcome
Clinical pregnancy rate
Time frame: 4 weeks after the embryo transfer
Number of clinical pregnancies (/No. of embryo transfers)
Implantation rate
Time frame: 4 weeks after embryo transfer
Number of embryos implanted (/number of embryos transferred)
2 secondary outcomes
Fertilization rate
Time frame: 18 hours after sperm injection
Embryo quality
Time frame: 36 and 72 hours after fertilization
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 2 Sep 2015.
- Derived from this study: PubMed 35278201Fancsovits P, Pribenszky C, Lehner A, Murber A, Kaszas Z, Nemes A, Urbancsek J. Prospective-randomized study comparing clinical outcomes of IVF treatments where embryos were cultured individually or in a microwell group culture dish. Biol Futur. 2022 Jun;73(2):229-236. doi: 10.1007/s42977-022-00113-8. Epub 2022 Mar 12.
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.
Janos Urbancsek, DSc principal investigator
Semmelweis University First Department of Obstetrics and Gynecology
Peter Fancsovits, Ph.D. study chair
Semmelweis University First Department of Obstetrics and Gynecology
Csaba Pribenszky, Ph.D. principal investigator
University of Veterinary Sciences, Budapest
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 Other Complications Associated With Artificial Fertilization, run by Semmelweis University at 1 site in Hungary.
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 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 2 Sep 2015. 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 Hungary. 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?
Clinical pregnancy rate (time frame: 4 weeks after the embryo transfer). The study lists 2 primary outcomes in all. 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 NCT01774006, 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 2 Sep 2015.