InfertilityNCT02077608
Hyaluronan in Embryo Transfer Media
An observational study of Infertility, run by Peter Fancsovits, Ph.D. at 1 site in Hungary.
Trial summary
Prospective randomized double blind comparison of hyaluronan enriched embryotransfer media and conventional embryotransfer media in human IVF treatments. Embryos selected for transfer are incubated in a culture media containing high concentration of hyaluronan or low concentration of hyaluronan. Read more about this study
- Who is it for?
- Ages 18 to 48 years, women only
- Conditions the study is for
- Infertility
- How many people
- 580 participants
- Where
- 1 siteHungary
- Study dates
- Jan 2010to Dec 2013
- 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 48 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 embryo transferred
Who cannot join
- IVF treatment with donated oocytes
- No embryo available for transfer
Trial locations and contacts
1 site in 1 country.
Hungary1 site
Semmelweis University First Department of Obstetrics and Gynecology
Budapest, 1088
About this study
Official title: Effect of Hyaluronan Enriched Embryo Transfer Media on IVF Outcome
Prospective randomized double blind comparison of hyaluronan enriched embryotransfer media and conventional embryotransfer media in human IVF treatments. Embryos selected for transfer are incubated in a culture media containing high concentration of hyaluronan or low concentration of hyaluronan.
Primary outcome: implantation and pregnancy rates
- Conditions
- Infertility
- Keywords
- In vitro fertilization, Embryotransfer, Hyaluronan, Pregnancy rate, Implantation rate
- 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 |
|---|---|---|
| Hyaluronan enriched transfer media | Embryos are incubated at least 10 minutes in hyaluronan enriched embryo transfer media before transfer | |
| Control group | Embryos are incubated in embryo transfer media containing low concentration of hyaluronan for at least 10 minutes before transfer |
What is being measured
The primary outcome is the main question the study is designed to answer.
Clinical pregnancy rate
Number of clinical pregnancies (gestational sacs visible by ultrasound examination) divided by the number of embryotransfers
Measured: 5 weeks after embryo transfer
Implantation rate
Number of embryos implanted (No. of gestational sacs) divided by the number of embryos implanted
Measured: 5 weeks after embryotransfer
Secondary outcomes (2)
Multiple pregnancy rate
Number of multiple pregnancies divided by the number of embryotransfers
Measured: 5 weeks after embryotransfer
Delivery rate
Number of delivery divided by the number of embryo transfers
Measured: 40 weeks after embryo transfer
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Mar 2014 (estimated)
- Study startJan 2010
- Primary completionAug 2012
- Study completionDec 2013
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
- Prospective
- Enrolment
- 580 participants (actual)
Sponsor and investigators
- Lead sponsor
- Peter Fancsovits, Ph.D.
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Peter Fancsovits, Ph.D., Semmelweis University
- Investigators
- Peter Fancsovits, Ph.D., Study chair, Semmelweis University First Department of Obstetrics and GynecologyJanos Urbancsek, MD, Ph.D., Principal investigator, Semmelweis University First Department of Obstetrics and GynecologyAdam Lehner, MSc, Principal investigator, Semmelweis University First Department of Obstetrics and Gynecology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02077608
- Sponsor's protocol ID
- SemmelweisU-002
- Status last verified
- Mar 2014
- First submitted
- 28 Feb 2014
- Last updated
- 4 Mar 2014
- Results posted
- No
- Data monitoring committee
- No
Publications
Bontekoe S, Heineman MJ, Johnson N, Blake D. Adherence compounds in embryo transfer media for assisted reproductive technologies. Cochrane Database Syst Rev. 2014 Feb 25;2014(2):CD007421. doi: 10.1002/14651858.CD007421.pub3.
PubMed 24567053
Study at a glance
From the registry record, last updated by the sponsor on 4 Mar 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Hyaluronan Enriched Embryo Transfer Media on IVF Outcome
- ClinicalTrials.gov ID
- NCT02077608
- Acronym / sponsor ID
- SemmelweisU-002
- Conditions
- Infertility
- Keywords
- In vitro fertilization, Embryotransfer, Hyaluronan, Pregnancy rate, Implantation rate
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 580 participants (actual)
- Lead sponsor
- Peter Fancsovits, Ph.D.University, hospital or other
- Study start
- Jan 2010
- Primary completion
- Aug 2012 (actual)
- Study completion
- Dec 2013 (actual)
- First posted
- 4 Mar 2014 (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 double blind comparison of hyaluronan enriched embryotransfer media and conventional embryotransfer media in human IVF treatments. Embryos selected for transfer are incubated in a culture media containing high concentration of hyaluronan or low concentration of hyaluronan.
Primary outcome: implantation and pregnancy rates
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Hyaluronan enriched transfer media | – | –Embryos are incubated at least 10 minutes in hyaluronan enriched embryo transfer media before transfer |
| Control group | – | –Embryos are incubated in embryo transfer media containing low concentration of hyaluronan for at least 10 minutes before transfer |
Who may qualify
- Ages
- 18 to 48 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 (3 listed)
- Infertile patients
- entering in vitro fertilization treatment
- at least 1 embryo transferred
Key exclusion criteria (2 listed)
- IVF treatment with donated oocytes
- No embryo available for transfer
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
Clinical pregnancy rate
Time frame: 5 weeks after embryo transfer
Number of clinical pregnancies (gestational sacs visible by ultrasound examination) divided by the number of embryotransfers
Implantation rate
Time frame: 5 weeks after embryotransfer
Number of embryos implanted (No. of gestational sacs) divided by the number of embryos implanted
2 secondary outcomes
Multiple pregnancy rate
Time frame: 5 weeks after embryotransfer
Delivery rate
Time frame: 40 weeks after embryo transfer
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 4 Mar 2014.
- Results publication: PubMed 24567053Bontekoe S, Heineman MJ, Johnson N, Blake D. Adherence compounds in embryo transfer media for assisted reproductive technologies. Cochrane Database Syst Rev. 2014 Feb 25;2014(2):CD007421. doi: 10.1002/14651858.CD007421.pub3.
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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.
Peter Fancsovits, Ph.D. study chair
Semmelweis University First Department of Obstetrics and Gynecology
Janos Urbancsek, MD, Ph.D. principal investigator
Semmelweis University First Department of Obstetrics and Gynecology
Adam Lehner, MSc principal investigator
Semmelweis University First Department of Obstetrics and Gynecology
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 Peter Fancsovits, Ph.D. 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 3 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: finished, as of the sponsor's last update on 4 Mar 2014. 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: 5 weeks after 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 NCT02077608, 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 4 Mar 2014.