Psychiatric DisorderNCT03569215
Psychiatric Disorders With Prolonged Infertility
An observational study of Psychiatric Disorder and Invitro Fertilization /Intracytoplasmic Spem Injection Failure, run by Tanta University at 1 site in Egypt.
Trial summary
Psychiatric disorders in women with prolonged infertility with or without IVF/ICSI failure will be included then a questionnaire will be applied plus psychiatric examinatins Read more about this study
- Who is it for?
- Any age, women only
- Conditions the study is for
- Psychiatric Disorder, Invitro Fertilization /Intracytoplasmic Spem Injection Failure
- What is being tested?
- Questionnaire
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 324 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Jul 2018to 31 Dec 2022
- How long will I take part?
- 1 Day
- Phase
- Observational
- 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 Any age
- Women only
- No healthy volunteers
- Child, Adult, Older adult
Study population: All infertile women with prolonged infertility with or without history of IVF/ICSI failure
Who may be able to join
- Infertile women
- prolonged infertility ≥ 5 years
- Failed invitro fertilization /intracytoplasmic spem injection for group 1
- not bearing any children
- accepting to share in the study.
Who cannot join
- patients with diagnosed psychiatric or neurologic disorders
- patients with diabetes mellitus or any anatomical defects in genital tract
- patients who didn't complete their questionnaires.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Psychiatric Disorders Among Egyptian Women With Prolonged Infertility With or Without Invitro Fertilization /Intracytoplasmic Spem Injection Failure
Psychiatric disorders in women with prolonged infertility with or without IVF/ICSI failure will be included then a questionnaire will be applied plus psychiatric examinatins
Read the detailed description
All patients will be recruited from both psychiatry and obstetrics and gynecology departments. Referred cases from gynecologists and Assisted reproductive technologies centers were also included.
Inclusion criteria:
Infertile couples Infertility >= 5 years invitro fertilization /intracytoplasmic spem injection failure for group 1 and not included for group 2
- Being tested
- Questionnaire
- Medical subject headings
- Mental Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
QuestionnaireBehavioural
Also called Psychiatric diagnostic tests
All included patients will be exposed to questionnaires and psychiatric diagnostic tests
| Study group | Role | What they receive |
|---|---|---|
| IVF/ICSI failure | These patients had prolonged infertility with one or more failure of IVF/ICSI cycles Receives: Behavioral: Questionnaire | |
| Prolonged infertility only | These patients had prolonged infertility without any trials of IVF/ICSI cycles Receives: Behavioral: Questionnaire |
What is being measured
The primary outcome is the main question the study is designed to answer.
Prevalence and types of psychiatric disorders among prolonged infertility couples
Incidence and most common types of psychiatric disorders
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jun 2018
- Study start1 Jul 2018
- Primary completion31 Dec 2022
- Study completion31 Dec 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Psychiatric DisorderStudies 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
- Observational
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Enrolment
- 324 participants (actual)
- Target duration
- 1 Day
Sponsor and investigators
- Lead sponsor
- Tanta University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ayman S Dawood, MD, Tanta University
- Investigators
- Ayman Dawood, MD, Study director, Lecturer at Tanta UniversityReham Amer, MD, Principal investigator, Lecturer at Tanta University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03569215
- Sponsor's protocol ID
- Ayman
- Status last verified
- Aug 2023
- First submitted
- 14 Jun 2018
- Last updated
- 3 Aug 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Individual participant data is secret as privacy and security of data is a must
Study at a glance
From the registry record, last updated by the sponsor on 3 Aug 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Psychiatric Disorders Among Egyptian Women With Prolonged Infertility With or Without Invitro Fertilization /Intracytoplasmic Spem Injection Failure
- ClinicalTrials.gov ID
- NCT03569215
- Acronym / sponsor ID
- Ayman
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 324 participants (actual)
- Lead sponsor
- Tanta UniversityUniversity, hospital or other
- Study start
- 1 Jul 2018 (actual)
- Primary completion
- 31 Dec 2022 (actual)
- Study completion
- 31 Dec 2022 (actual)
- First posted
- 26 Jun 2018 (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.
Psychiatric disorders in women with prolonged infertility with or without IVF/ICSI failure will be included then a questionnaire will be applied plus psychiatric examinatins
Detailed description
All patients will be recruited from both psychiatry and obstetrics and gynecology departments. Referred cases from gynecologists and Assisted reproductive technologies centers were also included.
Inclusion criteria:
Infertile couples Infertility >= 5 years invitro fertilization /intracytoplasmic spem injection failure for group 1 and not included for group 2
Study design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Target follow-up
- 1 Day
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| IVF/ICSI failure | – | Behavioral: QuestionnaireThese patients had prolonged infertility with one or more failure of IVF/ICSI cycles |
| Prolonged infertility only | – | Behavioral: QuestionnaireThese patients had prolonged infertility without any trials of IVF/ICSI cycles |
Who may qualify
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- All infertile women with prolonged infertility with or without history of IVF/ICSI failure
Key inclusion criteria (5 listed)
- Infertile women
- prolonged infertility ≥ 5 years
- Failed invitro fertilization /intracytoplasmic spem injection for group 1
- not bearing any children
- accepting to share in the study.
Key exclusion criteria (3 listed)
- patients with diagnosed psychiatric or neurologic disorders
- patients with diabetes mellitus or any anatomical defects in genital tract
- patients who didn't complete their questionnaires.
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 |
|---|---|---|
| QuestionnaireAlso: Psychiatric diagnostic testsAll included patients will be exposed to questionnaires and psychiatric diagnostic tests | Behavioural | IVF/ICSI failure, Prolonged infertility only |
Primary outcome
Prevalence and types of psychiatric disorders among prolonged infertility couples
Time frame: 6 months
Incidence and most common types of psychiatric disorders
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Aug 2023.
- Individual participant dataSharing planned: No. Individual participant data is secret as privacy and security of data is a must
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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.
Ayman Dawood, MD study director
Lecturer at Tanta University
Reham Amer, MD principal investigator
Lecturer at Tanta University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Psychiatric Disorder and Invitro Fertilization /Intracytoplasmic Spem Injection Failure, run by Tanta 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 5 inclusion and 3 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: finished, as of the sponsor's last update on 3 Aug 2023. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Prevalence and types of psychiatric disorders among prolonged infertility couples (time frame: 6 months). 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 3 Aug 2023.