COVID19COVAPEXNCT04456010
COVID-19 in ART: Perception and Experience
An observational study of COVID19 and Fertility Issues, run by University Hospital, Montpellier at 1 site in France.
Trial summary
Non-urgent medical care, such as fertility treatments, has been massively postponed during the past weeks due to the COVID19 pandemic. The lockdown and the closure of IVF centers might cause anxiety and depression among infertile couples, who are already exposed to the distressing experience of infertility and for… Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- COVID19, Fertility Issues, ART
- What is being tested?
- Questionnaire
- How many people
- 600 participants
- Where
- 1 siteFrance
- Study dates
- 1 Jun 2020to 30 Jul 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 18 to 60 years
- All sexes
- No healthy volunteers
- Adult
Study population: Infertile couple (male and female) who had a fertility treatment prescribed during the past 9 months (prescription after October 1st, 2019) in the fertility department of Montpellier Hospital
Who may be able to join
- Men and women who had a fertility treatment prescribed during the past 9 months in our Fertility department
Who cannot join
- Patient attending for a fertility preservation
- Patient attending for a preimplantation genetic testing (PGT-M or PGT-SR)
- Patient not fluent in French
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Assessing the Perception and the Personal Experience of the COVID19 Pandemic Among Infertile Couples Undergoing Assisted Reproductive Treatment (ART)
Non-urgent medical care, such as fertility treatments, has been massively postponed during the past weeks due to the COVID19 pandemic. The lockdown and the closure of IVF centers might cause anxiety and depression among infertile couples, who are already exposed to the distressing experience of infertility and for whom the wait for a baby already appears unending. Few data are available regarding the impact of SARS-CoV-2 on pregnant women and foetus, or on fertility.
This study aims to assess the views of infertile couple regarding the potential risks of COVID during their fertility treatment and their personal experience of the COVID pandemic and their expectation for further treatment .
- Conditions
- COVID19, Fertility Issues, ART
- Being tested
- Questionnaire
- Keywords
- fertility, risk perception, emotional experience
- Medical subject headings
- COVID-19, Infertility
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
QuestionnaireOther
Eligible patients will be selected from our electronical database and invited via email to participate.
| Study group | Role | What they receive |
|---|---|---|
| Infertile couple | Infertile couple who had a fertility treatment prescribed during the past 9 months which was not completed yet. Receives: Other: Questionnaire |
What is being measured
The primary outcome is the main question the study is designed to answer.
Personal experience of the COVID19 pandemic and the discontinuation of their fertility treatment pandemic and the discontinuation
Personal experience of the COVID19 pandemic and the discontinuation of their fertility treatment, via a survey
Measured: 1 day
Secondary outcomes (2)
Risk assessment
. Risk assessment by the patient, via a survey, regarding SARS-CoV-2 during a fertility treatment or during pregnancy. Perception of the risks linked to SARS-CoV-2 during their fertility treatment or during a pregnancy
Measured: 1 day
Patients'expectations regarding the management of an abrupt closure of the fertility center
Patients'expectations regarding the management of an abrupt closure of the fertility center, via a survey
Measured: 1 day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Jul 2020
- Study start1 Jun 2020
- Primary completion30 Jul 2020
- Study completion30 Jul 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for COVID19Studies 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
- Other
- Time perspective
- Prospective
- Enrolment
- 600 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Montpellier
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Noémie Ranisavljevic, M.D., Ph.D, Principal investigator, University Hospital, Montpellier
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04456010
- Sponsor's protocol ID
- RECHMPL20_0351
- Acronym
- COVAPEX
- Status last verified
- Dec 2020
- First submitted
- 15 Jun 2020
- Last updated
- 29 Dec 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: NC
Study at a glance
From the registry record, last updated by the sponsor on 29 Dec 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessing the Perception and the Personal Experience of the COVID19 Pandemic Among Infertile Couples Undergoing Assisted Reproductive Treatment (ART)
- ClinicalTrials.gov ID
- NCT04456010
- Acronym / sponsor ID
- COVAPEX / RECHMPL20_0351
- Conditions
- COVID19, Fertility Issues, ART
- Keywords
- fertility, risk perception, emotional experience
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 600 participants (actual)
- Lead sponsor
- University Hospital, MontpellierUniversity, hospital or other
- Study start
- 1 Jun 2020 (actual)
- Primary completion
- 30 Jul 2020 (actual)
- Study completion
- 30 Jul 2020 (actual)
- First posted
- 2 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.
Non-urgent medical care, such as fertility treatments, has been massively postponed during the past weeks due to the COVID19 pandemic. The lockdown and the closure of IVF centers might cause anxiety and depression among infertile couples, who are already exposed to the distressing experience of infertility and for whom the wait for a baby already appears unending. Few data are available regarding the impact of SARS-CoV-2 on pregnant women and foetus, or on fertility.
This study aims to assess the views of infertile couple regarding the potential risks of COVID during their fertility treatment and their personal experience of the COVID pandemic and their expectation for further treatment .
Study design
- Observational model
- Other
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Infertile couple | – | Other: QuestionnaireInfertile couple who had a fertility treatment prescribed during the past 9 months which was not completed yet. |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
- Study population
- Infertile couple (male and female) who had a fertility treatment prescribed during the past 9 months (prescription after October 1st, 2019) in the fertility department of Montpellier Hospital
Key inclusion criteria (1 listed)
- Men and women who had a fertility treatment prescribed during the past 9 months in our Fertility department
Key exclusion criteria (3 listed)
- Patient attending for a fertility preservation
- Patient attending for a preimplantation genetic testing (PGT-M or PGT-SR)
- Patient not fluent in French
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 |
|---|---|---|
| QuestionnaireEligible patients will be selected from our electronical database and invited via email to participate. | Other | Infertile couple |
Primary outcome
Personal experience of the COVID19 pandemic and the discontinuation of their fertility treatment pandemic and the discontinuation
Time frame: 1 day
Personal experience of the COVID19 pandemic and the discontinuation of their fertility treatment, via a survey
2 secondary outcomes
Risk assessment
Time frame: 1 day
Patients'expectations regarding the management of an abrupt closure of the fertility center
Time frame: 1 day
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 29 Dec 2020.
- Individual participant dataSharing planned: Undecided. NC
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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.
Noémie Ranisavljevic, M.D., Ph.D principal investigator
University Hospital, Montpellier
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 COVID19 and Fertility Issues, run by University Hospital, Montpellier at 1 site in France.
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 3 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 29 Dec 2020. 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 France. 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?
Personal experience of the COVID19 pandemic and the discontinuation of their fertility treatment pandemic and the discontinuation (time frame: 1 day). 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 29 Dec 2020; AzTrials last refreshed its copy on 26 Oct 2026.