IVMNCT04488211
IVM Survey Among Reproductive Medicine Specialists
An observational study of IVM, run by Universitair Ziekenhuis Brussel at 1 site in Belgium.
Trial summary
Although IVM as a laboratory technology in reproductive medicine has existed for many decades, there is a lack of well-designed studies comparing the efficiency and the patient satisfaction related to IVM as compared to standard ovarian stimulation for IVF. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- IVM
- What is being tested?
- Survey
- How many people
- 200 participants
- Where
- 1 siteBelgium
- Study dates
- 30 Jul 2020to 31 Dec 2020
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Fertility specialists around the globe who are affiliated to a public or private fertility clinic. Clinics will be identified based on whether they have worked with IVM previously but stopped, and clinics with appropriate size to offer IVM competence.
Who may be able to join
- IVF clinics that have worked with IVM previously but stopped
- clinics with appropriate size to offer IVM
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Survey of Fertility Specialists' Knowledge of, Experience With, and Attitudes Toward the Use of in Vitro Maturation of Oocytes in Reproductive Medicine
Although IVM as a laboratory technology in reproductive medicine has existed for many decades, there is a lack of well-designed studies comparing the efficiency and the patient satisfaction related to IVM as compared to standard ovarian stimulation for IVF. In view of this, and in order to identify unmet needs of fertility specialists with regard to the application of IVM, the investigator developed the idea of a worldwide web-based survey analysis of fertility specialists' insights and experiences regarding IVM.
Read the detailed description
The IVM survey will be structured as a series of open questions and multiple-choice questions. In most of the questions, a single answer will be required by participants. A small number of questions will allow multiple answers. The survey will be web-based. Invitations to participate in the survey will be emailed on three occasions to selected fertility specialists worldwide who are affiliated to a public or private fertility clinic. Clinics will be identified based on whether they have worked with IVM previously but stopped, and clinics with appropriate size to offer IVM competence. When no response is obtained from selected fertility specialists, e-mails will be sent to affiliated colleagues working at the same fertility clinic. When analyzing the survey results, care will be taken to analyse the responses per fertility clinic, as responses from different fertility specialists working in the same fertility clinic should be avoided. Results will be analysed using a method that assigns equal weight per clinic and a method that weights clinic responses based on treatment volume (number of IVF cycles).
- Conditions
- IVM
- Being tested
- Survey
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SurveyOther
The IVM survey will be structured as a series of open questions and multiple-choice questions.
| Study group | Role | What they receive |
|---|---|---|
| Prospective survey respondents | Invitations to participate in the survey will be emailed on three occasions to selected fertility specialists worldwide who are affiliated to a public or private fertility clinic. Receives: Other: Survey |
What is being measured
The primary outcome is the main question the study is designed to answer.
Name of the measurement: Application of in vitro maturation (IVM) of oocytes as a laboratory tool
Measurement tool: questionnaire; unit of measure: % of respondents who use oocyte in vitro maturation in the laboratory;
Measured: 1 month
Name of the measurement: Appreciation of IVM as a laboratory technique
Measurement tool: questionnaire; unit of measure: % of respondents who believe there is a role for IVM in the ART (assisted reproductive technology ) clinic
Measured: 1 month
Secondary outcomes (1)
Name of the measurement: Annual number of egg retrievals for IVM
Measurement tool: questionnaire; unit of measure: number
Measured: 1 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jul 2020
- Study start30 Jul 2020
- Primary completion31 Dec 2020
- Study completion31 Dec 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for IVMStudies of the same condition, open and under way.
- More trials run by Universitair Ziekenhuis BrusselThe 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
- 200 participants (actual)
Sponsor and investigators
- Lead sponsor
- Universitair Ziekenhuis Brussel
- Sponsor type
- University, hospital or other
- Collaborators
- CooperSurgical Inc.
- Responsible party
- Sponsor
- Investigators
- Michel De Vos, Principal investigator, Universitair Ziekenhuis Brussel
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04488211
- Sponsor's protocol ID
- IVM Survey V2 04062020
- Status last verified
- Jun 2020
- First submitted
- 6 Jul 2020
- Last updated
- 4 May 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 May 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Survey of Fertility Specialists' Knowledge of, Experience With, and Attitudes Toward the Use of in Vitro Maturation of Oocytes in Reproductive Medicine
- ClinicalTrials.gov ID
- NCT04488211
- Acronym / sponsor ID
- IVM Survey V2 04062020
- Conditions
- IVM
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 200 participants (actual)
- Lead sponsor
- Universitair Ziekenhuis BrusselUniversity, hospital or other
- Collaborators
- CooperSurgical Inc.
- Study start
- 30 Jul 2020 (actual)
- Primary completion
- 31 Dec 2020 (actual)
- Study completion
- 31 Dec 2020 (actual)
- First posted
- 27 Jul 2020 (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.
Although IVM as a laboratory technology in reproductive medicine has existed for many decades, there is a lack of well-designed studies comparing the efficiency and the patient satisfaction related to IVM as compared to standard ovarian stimulation for IVF. In view of this, and in order to identify unmet needs of fertility specialists with regard to the application of IVM, the investigator developed the idea of a worldwide web-based survey analysis of fertility specialists' insights and experiences regarding IVM.
Detailed description
The IVM survey will be structured as a series of open questions and multiple-choice questions. In most of the questions, a single answer will be required by participants. A small number of questions will allow multiple answers. The survey will be web-based. Invitations to participate in the survey will be emailed on three occasions to selected fertility specialists worldwide who are affiliated to a public or private fertility clinic. Clinics will be identified based on whether they have worked with IVM previously but stopped, and clinics with appropriate size to offer IVM competence. When no response is obtained from selected fertility specialists, e-mails will be sent to affiliated colleagues working at the same fertility clinic. When analyzing the survey results, care will be taken to analyse the responses per fertility clinic, as responses from different fertility specialists working in the same fertility clinic should be avoided. Results will be analysed using a method that assigns equal weight per clinic and a method that weights clinic responses based on treatment volume (number of IVF cycles).
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Prospective survey respondents | – | Other: SurveyInvitations to participate in the survey will be emailed on three occasions to selected fertility specialists worldwide who are affiliated to a public or private fertility clinic. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Fertility specialists around the globe who are affiliated to a public or private fertility clinic. Clinics will be identified based on whether they have worked with IVM previously but stopped, and clinics with appropriate size to offer IVM competence.
Key inclusion criteria (2 listed)
- IVF clinics that have worked with IVM previously but stopped
- clinics with appropriate size to offer IVM
Key exclusion criteria (0 listed)
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 |
|---|---|---|
| SurveyThe IVM survey will be structured as a series of open questions and multiple-choice questions. | Other | Prospective survey respondents |
Primary outcome
Name of the measurement: Application of in vitro maturation (IVM) of oocytes as a laboratory tool
Time frame: 1 month
Measurement tool: questionnaire; unit of measure: % of respondents who use oocyte in vitro maturation in the laboratory;
Name of the measurement: Appreciation of IVM as a laboratory technique
Time frame: 1 month
Measurement tool: questionnaire; unit of measure: % of respondents who believe there is a role for IVM in the ART (assisted reproductive technology ) clinic
1 secondary outcome
Name of the measurement: Annual number of egg retrievals for IVM
Time frame: 1 month
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 May 2021.
- Individual participant dataSharing planned: No
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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.
Michel De Vos principal investigator
Universitair Ziekenhuis Brussel
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 IVM, run by Universitair Ziekenhuis Brussel at 1 site in Belgium.
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 0 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 May 2021. 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 Belgium. 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?
Name of the measurement: Application of in vitro maturation (IVM) of oocytes as a laboratory tool (time frame: 1 month). 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?
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 May 2021.