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Impact of COVID-19 on Psychological Status in Case of IVF Interrupted or Postponed

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04395755
Recruitment Status : Completed
First Posted : May 20, 2020
Last Update Posted : July 28, 2020
Sponsor:
Information provided by (Responsible Party):
Fabio Barra, Ospedale Policlinico San Martino

Brief 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.

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.


Condition or disease Intervention/treatment
Infertility, Female ART IVF COVID-19 Behavioral: Generalized Anxiety Disorder-7 (GAD-7) Behavioral: Patient Health Questionnaire-9 (PHQ-9)

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Study Type : Observational
Actual Enrollment : 503 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Impact of COVID-19 Pandemic on the Psychological Status of Infertile Patients Who Had in Vitro Fertilization Treatment Interrupted or Postponed
Actual Study Start Date : April 1, 2020
Actual Primary Completion Date : May 15, 2020
Actual Study Completion Date : May 15, 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Anxiety Infertility

Group/Cohort Intervention/treatment
Infertile women who had the IVF treatment postponed or delayed Behavioral: 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.

Behavioral: Patient Health Questionnaire-9 (PHQ-9)
The PHQ-9 is a multipurpose instrument for screening, diagnosing, monitoring and measuring the severity of depression.




Primary Outcome Measures :
  1. Severity of anxiety [ Time Frame: 1-4 weeks after communication of interrupted or delayed IVF ]
  2. Severity of depression [ Time Frame: 1-4 weeks after communication of interrupted or delayed IVF ]


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patients with IVF treatment interrupted or delayed during COVID-19 pandemic
Criteria

Inclusion Criteria:

  • patients with IVF treatment interrupted or delayed during COVID-19 pandemic
  • patients with signed informed consent
  • patients with more than 18 years

Exclusion Criteria:

  • patients with already diagnosed psychiatric disorders

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04395755


Locations
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Italy
IRCCS Ospedale Policlinico San Martino
Genoa, Italy, 16132
Sponsors and Collaborators
Ospedale Policlinico San Martino
Publications:
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Responsible Party: Fabio Barra, Principal investigator, Ospedale Policlinico San Martino
ClinicalTrials.gov Identifier: NCT04395755    
Other Study ID Numbers: COVID-19-NOIVF
First Posted: May 20, 2020    Key Record Dates
Last Update Posted: July 28, 2020
Last Verified: July 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Infertility
Infertility, Female