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

NCT04395755 | Completed

• 1 other identifier: COVID-19-NOIVF
• Study Type: observational
• Target: 503
• Locations: 1 country
• Sites: 1

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.

Conditions

Infertility, Female; ART; IVF; COVID-19

Outcome Measures

Primary Outcomes (2)

• Severity of anxiety

  1-4 weeks after communication of interrupted or delayed IVF

• Severity of depression

  1-4 weeks after communication of interrupted or delayed IVF

Study Arms (1)

Infertile women who had the IVF treatment postponed or delayed

Behavioral: Generalized Anxiety Disorder-7 (GAD-7); Behavioral: Patient Health Questionnaire-9 (PHQ-9)

Interventions

Generalized Anxiety Disorder-7 (GAD-7) BEHAVIORAL

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.

Infertile women who had the IVF treatment postponed or delayed

Patient Health Questionnaire-9 (PHQ-9) BEHAVIORAL

The PHQ-9 is a multipurpose instrument for screening, diagnosing, monitoring and measuring the severity of depression.

Infertile women who had the IVF treatment postponed or delayed

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients with IVF treatment interrupted or delayed during COVID-19 pandemic

You may qualify if:

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

You may not qualify if:

• patients with already diagnosed psychiatric disorders

Sponsors & Collaborators

• Piazza della Vittoria 14 Studio Medico - Ginecologia e Ostetricia: lead

Study Sites (1)

IRCCS Ospedale Policlinico San Martino

Genoa, 16132, Italy

Location

Related Publications (2)

• 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.

  PMID: 32404170 BACKGROUND

• Barra 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.

  PMID: 33252292 DERIVED

MeSH Terms

Conditions

Infertility, Female; COVID-19

Interventions

Patient Health Questionnaire

Condition Hierarchy (Ancestors)

Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases; Infertility; Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Surveys and Questionnaires; Data Collection; Epidemiologic Methods; Investigative Techniques; Psychological Tests; Behavioral Disciplines and Activities; Health Care Evaluation Mechanisms; Quality of Health Care; Health Care Quality, Access, and Evaluation; Public Health; Environment and Public Health

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal investigator

Study Record Dates

• First Submitted: May 19, 2020
• First Posted: May 20, 2020
• Study Start: April 1, 2020
• Primary Completion: May 15, 2020
• Study Completion: May 15, 2020
• Last Updated: February 22, 2022

Record last verified: 2022-02

Locations

IT (1)