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

COVID-19 Clinical Trial

Official title:

Impact of COVID-19 Pandemic on the Psychological Status of Infertile Patients Who Had in Vitro Fertilization Treatment Interrupted or Postponed

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04395755
• Other study ID #: COVID-19-NOIVF
• Status: Completed
• Start date: April 1, 2020
• Est. completion date: May 15, 2020

Study information

• Verified date: February 2022
• Source: Piazza della Vittoria 14 Studio Medico - Ginecologia e Ostetricia
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 503
• Est. completion date: May 15, 2020
• Est. primary completion date: May 15, 2020
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• ART
• COVID-19
• Infertility
• Infertility, Female
• IVF

Intervention

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

Locations

Country	Name	City	State
Italy	IRCCS Ospedale Policlinico San Martino	Genoa

Sponsors (1)

Lead Sponsor	Collaborator
Piazza della Vittoria 14 Studio Medico - Ginecologia e Ostetricia

Country where clinical trial is conducted

Italy, 

References & Publications (1)

Alviggi C, Esteves SC, Orvieto R, Conforti A, La Marca A, Fischer R, Andersen CY, Bühler 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Severity of anxiety		1-4 weeks after communication of interrupted or delayed IVF
Primary	Severity of depression		1-4 weeks after communication of interrupted or delayed IVF