NCT05658848

Brief Summary

Effect of collaborative infertility counseling on coping strategies and marital satisfaction among women undergoing in vitro fertilization: a randomized control trial

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
68

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Nov 2022

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 1, 2022

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

December 9, 2022

Completed
12 days until next milestone

First Posted

Study publicly available on registry

December 21, 2022

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2023

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2023

Completed
Last Updated

December 21, 2022

Status Verified

December 1, 2022

Enrollment Period

4 months

First QC Date

December 9, 2022

Last Update Submit

December 17, 2022

Conditions

Outcome Measures

Primary Outcomes (2)

  • Coping strategies

    The Ways of Coping-Revised (WOC-R) questionnaire will be adopted from Folkman, Lazarus, Pimley, \& Novacek, (1987) to evaluate women coping styles. It contains 31 items and 8 subscales graded by a 3-point Likert scale. It is divided into problem-focused and emotion-focused coping strategies. The problem-focused strategy includes 4 subscales: planful problem solving, seeking social support, accepting responsibility, and positive reappraisal. The emotional-focused coping strategy includes 4 subscales: confrontive coping, self-controlling, distancing, and escape/avoidance. The responses will be rated on a 3-point scale (0 = didn't use to 2 = used all the time).

    Three Months

  • Marital Satisfaction

    The Marital Satisfaction Index (MSI) was developed by Cheung \& Hudson, (1982) to measure the degree of marital satisfaction. It consists of 25 items of which 13 are positively worded and 12 are negatively worded. The responses will be rated on a 5-point Likert scale (1 = None of the time, 2 = Very rarely, 3 = Sometimes, 4 = Most of the time, and 5 = All the time). The minimum and maximum scores of the MSI are 25 and 75, respectively. The higher score (above 30) indicates women's dissatisfaction. The GHQ-28 and FPI will be used to assess women's general health and perceived fertility-related stress respectively (Goldberg \& Hillier, 1979; Sherrard, Newton, \& Glavac, 1999).

    Three Months

Study Arms (2)

women cases

EXPERIMENTAL
Other: Collaborative infertility counseling

women control

NO INTERVENTION

Interventions

Collaborative infertility counseling for coping stratigies and marital satisfaction

Also known as: Counseling
women cases

Eligibility Criteria

Age20 Years - 45 Years
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • age 20 to 45 years
  • having a general health score below 28,
  • can read and write,

You may not qualify if:

  • psychiatric problems,
  • previous assisted reproductive technology failure,
  • leave the intervention for any reason and
  • women suddenly experience severe traumatic or psychological events.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Mansoura University hospitals

Al Mansurah, Egypt

RECRUITING

MeSH Terms

Conditions

Infertility

Interventions

Counseling

Condition Hierarchy (Ancestors)

Genital DiseasesUrogenital Diseases

Intervention Hierarchy (Ancestors)

Mental Health ServicesBehavioral Disciplines and ActivitiesCommunity Health ServicesHealth ServicesHealth Care Facilities Workforce and Services

Central Study Contacts

Mohamed Zoromba, PhD

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

December 9, 2022

First Posted

December 21, 2022

Study Start

November 1, 2022

Primary Completion

March 1, 2023

Study Completion

April 1, 2023

Last Updated

December 21, 2022

Record last verified: 2022-12

Locations