Fertility IssuesNCT05658848
Effect of Collaborative Infertility Counseling on Coping Strategies and Marital Satisfaction
A study testing Collaborative infertility counseling in people with Fertility Issues, run by Port Said University at 1 site in Egypt.
Trial summary
Effect of collaborative infertility counseling on coping strategies and marital satisfaction among women undergoing in vitro fertilization: a randomized control trial Read more about this study
- Who is it for?
- Ages 20 to 45 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Fertility Issues
- What is being tested?
- Collaborative infertility counseling
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 68 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Nov 2022to 1 Apr 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 45 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
None listed.
Who cannot join
- psychiatric problems,
- previous assisted reproductive technology failure,
- leave the intervention for any reason and
- women suddenly experience severe traumatic or psychological events.
Trial locations and contacts
1 site in 1 country.
Egypt1 site, 1 recruiting
- Recruiting
Mansoura University hospitals
Al Mansurah
Mohamed Zoromba, PhD, 0201008388226, zromba2010@mans.edu.eg
About this study
Official title: Effect of Collaborative Infertility Counseling on Coping Strategies and Marital Satisfaction Among Women Undergoing in Vitro Fertilization: A Randomized Control Trial
Effect of collaborative infertility counseling on coping strategies and marital satisfaction among women undergoing in vitro fertilization: a randomized control trial
- Conditions
- Fertility Issues
- Being tested
- Collaborative infertility counseling
- Medical subject headings
- Infertility
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Collaborative infertility counselingOther
Also called Counseling
Collaborative infertility counseling for coping stratigies and marital satisfaction
| Study group | Role | What they receive |
|---|---|---|
| women cases | Experimental | Not described Receives: Other: Collaborative infertility counseling |
| women control | No intervention | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: 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).
Measured: Three Months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Dec 2022
- Study start1 Nov 2022
- Primary completion1 Mar 2023 (estimated)
- Study completion1 Apr 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Fertility IssuesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 68 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Port Said University
- Sponsor type
- University, hospital or other
- Collaborators
- Mansoura University, Prince Sattam Bin Abdulaziz University
- Responsible party
- Principal investigator, Mohamed Ali Abdelsattar Zoromba, Port Said University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05658848
- Sponsor's protocol ID
- P.0335
- Status last verified
- Dec 2022
- First submitted
- 9 Dec 2022
- Last updated
- 21 Dec 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Dec 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Collaborative Infertility Counseling on Coping Strategies and Marital Satisfaction Among Women Undergoing in Vitro Fertilization: A Randomized Control Trial
- ClinicalTrials.gov ID
- NCT05658848
- Acronym / sponsor ID
- P.0335
- Conditions
- Fertility Issues
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 68 participants (estimated)
- Lead sponsor
- Port Said UniversityUniversity, hospital or other
- Collaborators
- Mansoura University, Prince Sattam Bin Abdulaziz University
- Study start
- 1 Nov 2022 (actual)
- Primary completion
- 1 Mar 2023 (estimated)
- Study completion
- 1 Apr 2023 (estimated)
- First posted
- 21 Dec 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Effect of collaborative infertility counseling on coping strategies and marital satisfaction among women undergoing in vitro fertilization: a randomized control trial
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| women cases | Experimental | Other: Collaborative infertility counseling |
| women control | No intervention | – |
Who may qualify
- Ages
- 20 to 45 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (0 listed)
Key exclusion criteria (4 listed)
- psychiatric problems,
- previous assisted reproductive technology failure,
- leave the intervention for any reason and
- women suddenly experience severe traumatic or psychological events.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Collaborative infertility counselingAlso: CounselingCollaborative infertility counseling for coping stratigies and marital satisfaction | Other | women cases |
Primary outcome
Coping strategies
Time frame: Three Months
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).
Marital Satisfaction
Time frame: Three Months
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).
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Dec 2022.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Collaborative infertility counseling in people with Fertility Issues, run by Port Said University at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 0 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 21 Dec 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Mohamed Zoromba, PhD (0201008388226, zromba2010@mans.edu.eg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Coping strategies (time frame: Three Months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Dec 2022.