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

Sponsor

Piazza della Vittoria 14 Studio Medico - Ginecologia e Ostetricia (Other)

Overall Status

Completed

CT.gov ID

NCT04395755

Collaborator

(none)

503

Enrollment

Location

1.4

Actual Duration (Months)

348

Patients Per Site Per Month

Study Details

Study Description

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	Phase
Infertility, Female ART IVF COVID-19	Behavioral: Generalized Anxiety Disorder-7 (GAD-7) Behavioral: Patient Health Questionnaire-9 (PHQ-9)

Study Design

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 :

Apr 1, 2020

Actual Primary Completion Date :

May 15, 2020

Actual Study Completion Date :

May 15, 2020

Arms and Interventions

Arm	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.

Arm

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.

Outcome Measures

Primary Outcome Measures

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]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

Female

Accepts Healthy Volunteers:

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	IRCCS Ospedale Policlinico San Martino	Genoa		Italy	16132

Sponsors and Collaborators

Piazza della Vittoria 14 Studio Medico - Ginecologia e Ostetricia

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

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.

Responsible Party:

Simone Ferrero, Principal investigator, Ospedale Policlinico San Martino

ClinicalTrials.gov Identifier:

NCT04395755

Other Study ID Numbers:

COVID-19-NOIVF

First Posted:

May 20, 2020

Last Update Posted:

Feb 22, 2022

Last Verified:

Feb 1, 2022

Individual Participant Data (IPD) Sharing Statement:

Undecided

Plan to Share IPD:

Undecided

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Additional relevant MeSH terms:

COVID-19

Infertility

Infertility, Female

Study Results

No Results Posted as of Feb 22, 2022