Infertility, FemaleNCT04395755
Impact of COVID-19 on Psychological Status in Case of IVF Interrupted or Postponed
An observational study of Infertility, Female and ART, run by Piazza della Vittoria 14 Studio Medico - Ginecologia e Ostetricia at 1 site in Italy.
Trial summary
Infertility is a severely distressing experience for many couples. Depression and anxiety are psychological disorders associated with infertility, and they may worsen during infertility treatments. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Infertility, Female, ART, IVF
- What is being tested?
- Generalized Anxiety Disorder-7 (GAD-7) and Patient Health Questionnaire-9 (PHQ-9)
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 503 participants
- Where
- 1 siteItaly
- Study dates
- 1 Apr 2020to 15 May 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 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Study population: Patients with IVF treatment interrupted or delayed during COVID-19 pandemic
Who may be able to join
- patients with IVF treatment interrupted or delayed during COVID-19 pandemic
- patients with signed informed consent
- patients with more than 18 years
Who cannot join
- patients with already diagnosed psychiatric disorders
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Impact of COVID-19 Pandemic on the Psychological Status of Infertile Patients Who Had in Vitro Fertilization Treatment Interrupted or Postponed
Infertility is a severely distressing experience for many couples. Depression and anxiety are psychological disorders associated with infertility, and they may worsen during infertility treatments.
This study times to understand the changes in the psychological status of infertile patients who had in vitro fertilization (IVF) treatment interrupted or postponed because of the COVID-19 pandemic.
- Conditions
- Infertility, Female, ART, IVF, COVID-19
- Being tested
- Generalized Anxiety Disorder-7 (GAD-7), Patient Health Questionnaire-9 (PHQ-9)
- Medical subject headings
- Infertility, Female, COVID-19
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Generalized Anxiety Disorder-7 (GAD-7)Behavioural
The GAD-7 is useful in primary care and mental health settings as a screening tool and symptom severity measure for the four most common anxiety disorders.
Patient Health Questionnaire-9 (PHQ-9)Behavioural
The PHQ-9 is a multipurpose instrument for screening, diagnosing, monitoring and measuring the severity of depression.
| Study group | Role | What they receive |
|---|---|---|
| Infertile women who had the IVF treatment postponed or delayed | Not described Receives: Behavioral: Generalized Anxiety Disorder-7 (GAD-7); Behavioral: Patient Health Questionnaire-9 (PHQ-9) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Severity of anxiety
Measured: 1-4 weeks after communication of interrupted or delayed IVF
Severity of depression
Measured: 1-4 weeks after communication of interrupted or delayed IVF
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 May 2020
- Study start1 Apr 2020
- Primary completion15 May 2020
- Study completion15 May 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Infertility, FemaleStudies 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
- 503 participants (actual)
Sponsor and investigators
- Lead sponsor
- Piazza della Vittoria 14 Studio Medico - Ginecologia e Ostetricia
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Simone Ferrero, Ospedale Policlinico San Martino
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04395755
- Sponsor's protocol ID
- COVID-19-NOIVF
- Status last verified
- Feb 2022
- First submitted
- 19 May 2020
- Last updated
- 22 Feb 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Alviggi C, Esteves SC, Orvieto R, Conforti A, La Marca A, Fischer R, Andersen CY, Buhler K, Sunkara SK, Polyzos NP, Strina I, Carbone L, Bento FC, Galliano D, Yarali H, Vuong LN, Grynberg M, Drakopoulos P, Xavier P, Llacer J, Neuspiller F, Horton M, Roque M, Papanikolaou E, Banker M, Dahan MH, Foong S, Tournaye H, Blockeel C, Vaiarelli A, Humaidan P, Ubaldi FM; POSEIDON (Patient-Oriented Strategies Encompassing IndividualizeD Oocyte Number) group. COVID-19 and assisted reproductive technology services: repercussions for patients and proposal for individualized clinical management. Reprod Biol Endocrinol. 2020 May 13;18(1):45. doi: 10.1186/s12958-020-00605-z.
PubMed 32404170Barra F, La Rosa VL, Vitale SG, Commodari E, Altieri M, Scala C, Ferrero S. Psychological status of infertile patients who had in vitro fertilization treatment interrupted or postponed due to COVID-19 pandemic: a cross-sectional study. J Psychosom Obstet Gynaecol. 2022 Jun;43(2):145-152. doi: 10.1080/0167482X.2020.1853095. Epub 2020 Nov 30.
PubMed 33252292
Study at a glance
From the registry record, last updated by the sponsor on 22 Feb 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of COVID-19 Pandemic on the Psychological Status of Infertile Patients Who Had in Vitro Fertilization Treatment Interrupted or Postponed
- ClinicalTrials.gov ID
- NCT04395755
- Acronym / sponsor ID
- COVID-19-NOIVF
- Conditions
- Infertility, Female, ART, IVF, COVID-19
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 503 participants (actual)
- Lead sponsor
- Piazza della Vittoria 14 Studio Medico - Ginecologia e OstetriciaUniversity, hospital or other
- Study start
- 1 Apr 2020 (actual)
- Primary completion
- 15 May 2020 (actual)
- Study completion
- 15 May 2020 (actual)
- First posted
- 20 May 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.
Infertility is a severely distressing experience for many couples. Depression and anxiety are psychological disorders associated with infertility, and they may worsen during infertility treatments.
This study times to understand the changes in the psychological status of infertile patients who had in vitro fertilization (IVF) treatment interrupted or postponed because of the COVID-19 pandemic.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Infertile women who had the IVF treatment postponed or delayed | – | Behavioral: Generalized Anxiety Disorder-7 (GAD-7), Behavioral: Patient Health Questionnaire-9 (PHQ-9) |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with IVF treatment interrupted or delayed during COVID-19 pandemic
Key inclusion criteria (3 listed)
- patients with IVF treatment interrupted or delayed during COVID-19 pandemic
- patients with signed informed consent
- patients with more than 18 years
Key exclusion criteria (1 listed)
- patients with already diagnosed psychiatric disorders
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 |
|---|---|---|
| Generalized Anxiety Disorder-7 (GAD-7)The GAD-7 is useful in primary care and mental health settings as a screening tool and symptom severity measure for the four most common anxiety disorders. | Behavioural | Infertile women who had the IVF treatment postponed or delayed |
| Patient Health Questionnaire-9 (PHQ-9)The PHQ-9 is a multipurpose instrument for screening, diagnosing, monitoring and measuring the severity of depression. | Behavioural | Infertile women who had the IVF treatment postponed or delayed |
Primary outcome
Severity of anxiety
Time frame: 1-4 weeks after communication of interrupted or delayed IVF
Severity of depression
Time frame: 1-4 weeks after communication of interrupted or delayed IVF
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 22 Feb 2022.
- Background: PubMed 32404170Alviggi C, Esteves SC, Orvieto R, Conforti A, La Marca A, Fischer R, Andersen CY, Buhler K, Sunkara SK, Polyzos NP, Strina I, Carbone L, Bento FC, Galliano D, Yarali H, Vuong LN, Grynberg M, Drakopoulos P, Xavier P, Llacer J, Neuspiller F, Horton M, Roque M, Papanikolaou E, Banker M, Dahan MH, Foong S, Tournaye H, Blockeel C, Vaiarelli A, Humaidan P, Ubaldi FM; POSEIDON (Patient-Oriented Strategies Encompassing IndividualizeD Oocyte Number) group. COVID-19 and assisted reproductive technology services: repercussions for patients and proposal for individualized clinical management. Reprod Biol Endocrinol. 2020 May 13;18(1):45. doi: 10.1186/s12958-020-00605-z.
- Derived from this study: PubMed 33252292Barra F, La Rosa VL, Vitale SG, Commodari E, Altieri M, Scala C, Ferrero S. Psychological status of infertile patients who had in vitro fertilization treatment interrupted or postponed due to COVID-19 pandemic: a cross-sectional study. J Psychosom Obstet Gynaecol. 2022 Jun;43(2):145-152. doi: 10.1080/0167482X.2020.1853095. Epub 2020 Nov 30.
- Individual participant dataSharing planned: Undecided
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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.
The record lists no contact. Use the official record to reach the sponsor.
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, Female and ART, run by Piazza della Vittoria 14 Studio Medico - Ginecologia e Ostetricia at 1 site in Italy.
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 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 22 Feb 2022. 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 Italy. 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?
Severity of anxiety (time frame: 1-4 weeks after communication of interrupted or delayed IVF). 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 NCT04395755, which also lists 2 linked publications.
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 22 Feb 2022.