In Vitro FertilizationNCT05881044
Psychiatric and Social Impacts of IVF
An observational study of In Vitro Fertilization, run by Assiut University.
Trial summary
To asses psychiatric impacts of In vitro fertilization. Read more about this study
- Who is it for?
- Ages 18 to 40 years
- Conditions the study is for
- In Vitro Fertilization
- What is being tested?
- Psychiatric interview
- How many people
- 52 participants
- Where
- No sites listed yet
- Study dates
- 1 Jun 2023to 1 Jan 2024
- 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 18 to 40 years
- All sexes
- Adult
Study population: 1. Psychiatric interview which include personal identification, present history, past history and family history 2. Complete physical and Neurological Examination. 3. Mini Neuropsychiatric Interview scale. (MINI): to diagnosis psychiatric disorders 4. Symptom checklist 90(SCL 90) 5. Quality of life questionnaire. 6. Hamilton Depression scale. 7. Hamilton Anxiety scale. 8. Socioeconomic scale (A.El.Gilany,A.El.Wehady,and M.EL.Wasify)
Who may be able to join
- Couples who perform or planning or failed to perform in vitro fertilization.
- Age from 18y To 40y .
Who cannot join
- Couples with any Psychiatric disorders prior to marriage.
- Couples with any physical or mental handcapes.
- refusal of couples to give consent to join the study.
Trial locations and contacts
No sites are listed yet.
Dr.Wageh Abd Elnasser contact
About this study
Official title: Psychiatric and Social Impacts of In Vitro Fertilization.
To asses psychiatric impacts of In vitro fertilization.
Read the detailed description
Infertility and its treatment represent a global health area of increasing importance. Individuals experiencing infertility represent around 8-10% of couples worldwide.
The demand for assisted reproduction techniques such as in-vitro fertilization (IVF) has increased in developed countries over the past decades, and is predicted to increase further in those to come .
This could be further boosted by numbers in resource-limited settings of the developing world, where an estimated 180 million couples are experiencing infertility.
The efficacy of IVF among the assisted fertility options has led an increasing number of individuals to seek this specific treatment. More than a half million babies are now born each year from IVF, as a result of over two million estimated annual treatment cycles . Yet it is also a relatively invasive and disruptive process that can be both physically and psychologically demanding .
Infertility itself has been associated with a higher prevalence of depression and anxiety, lower quality of life, and lower self-esteem .
The IVF process-which includes injectable medication and multiple blood tests, clinic appointments and procedures, waiting periods and anticipation of outcomes at each phase-may lead to further psychological stress. This can be exacerbated by disturbances to an individual's work and routine and the financial pressure of this costly treatment , and may be worse after multiple failed cycles .
- Conditions
- In Vitro Fertilization
- Being tested
- Psychiatric interview
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Psychiatric interviewOther
- Psychiatric interview which include personal identification, present history, past history and family history
- Complete physical and Neurological Examination.
- Mini Neuropsychiatric Interview scale. (MINI): to diagnosis psychiatric disorders
- Symptom checklist 90(SCL 90)
- Quality of life questionnaire.
- Hamilton Depression scale.
- Hamilton Anxiety scale.
- Socioeconomic scale (A.El.Gilany,A.El.Wehady,and M.EL.Wasify)
What is being measured
The primary outcome is the main question the study is designed to answer.
Measurement of depression in couples with IVF .
Measurement of psychiatric aspects in patients who perform or plan to perform in vitro fertilization by psychometric scales for measurement of depression such as The Hamilton Depression Rating Scale (HAM-D or HDRS) depression scale.
- Scores below 7 generally represent the absence or remission of depression.
- Scores between 7-17 represent mild depression
- Scores between 18-24 represent moderate depression
- Scores 25 and above represent severe depression
Measured: Baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 May 2023
- Study start1 Jun 2023 (estimated)
- Primary completion1 Sep 2023 (estimated)
- Study completion1 Jan 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for In Vitro FertilizationStudies of the same condition, open and under way.
- More trials run by Assiut UniversityThe sponsor's other registered studies.
- 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
- Other
- Time perspective
- Cross-sectional
- Enrolment
- 52 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Marina Hanna Abd elmalak bakhet, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05881044
- Sponsor's protocol ID
- Impacts of IVF
- Status last verified
- May 2023
- First submitted
- 24 Mar 2023
- Last updated
- 31 May 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Mascarenhas MN, Flaxman SR, Boerma T, Vanderpoel S, Stevens GA. National, regional, and global trends in infertility prevalence since 1990: a systematic analysis of 277 health surveys. PLoS Med. 2012;9(12):e1001356. doi: 10.1371/journal.pmed.1001356. Epub 2012 Dec 18.
PubMed 23271957Kocourkova J, Burcin B, Kucera T. Demographic relevancy of increased use of assisted reproduction in European countries. Reprod Health. 2014 May 26;11:37. doi: 10.1186/1742-4755-11-37.
PubMed 24885428
Study at a glance
From the registry record, last updated by the sponsor on 31 May 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Psychiatric and Social Impacts of In Vitro Fertilization.
- ClinicalTrials.gov ID
- NCT05881044
- Acronym / sponsor ID
- Impacts of IVF
- Conditions
- In Vitro Fertilization
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 52 participants (estimated)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- 1 Jun 2023 (estimated)
- Primary completion
- 1 Sep 2023 (estimated)
- Study completion
- 1 Jan 2024 (estimated)
- First posted
- 30 May 2023 (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.
To asses psychiatric impacts of In vitro fertilization.
Detailed description
Infertility and its treatment represent a global health area of increasing importance. Individuals experiencing infertility represent around 8-10% of couples worldwide.
The demand for assisted reproduction techniques such as in-vitro fertilization (IVF) has increased in developed countries over the past decades, and is predicted to increase further in those to come .
This could be further boosted by numbers in resource-limited settings of the developing world, where an estimated 180 million couples are experiencing infertility.
The efficacy of IVF among the assisted fertility options has led an increasing number of individuals to seek this specific treatment. More than a half million babies are now born each year from IVF, as a result of over two million estimated annual treatment cycles . Yet it is also a relatively invasive and disruptive process that can be both physically and psychologically demanding .
Infertility itself has been associated with a higher prevalence of depression and anxiety, lower quality of life, and lower self-esteem .
The IVF process-which includes injectable medication and multiple blood tests, clinic appointments and procedures, waiting periods and anticipation of outcomes at each phase-may lead to further psychological stress. This can be exacerbated by disturbances to an individual's work and routine and the financial pressure of this costly treatment , and may be worse after multiple failed cycles .
Study design
- Observational model
- Other
- Time perspective
- Cross-sectional
Who may qualify
- Ages
- 18 to 40 years
- Sex
- All
- Age groups
- Adult
- Study population
- 1. Psychiatric interview which include personal identification, present history, past history and family history 2. Complete physical and Neurological Examination. 3. Mini Neuropsychiatric Interview scale. (MINI): to diagnosis psychiatric disorders 4. Symptom checklist 90(SCL 90) 5. Quality of life questionnaire. 6. Hamilton Depression scale. 7. Hamilton Anxiety scale. 8. Socioeconomic scale (A.El.Gilany,A.El.Wehady,and M.EL.Wasify)
Key inclusion criteria (2 listed)
- Couples who perform or planning or failed to perform in vitro fertilization.
- Age from 18y To 40y .
Key exclusion criteria (3 listed)
- Couples with any Psychiatric disorders prior to marriage.
- Couples with any physical or mental handcapes.
- refusal of couples to give consent to join the study.
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 |
|---|---|---|
| Psychiatric interview1. Psychiatric interview which include personal identification, present history, past history and family history 2. Complete physical and Neurological Examination. 3. Mini Neuropsychiatric Interview scale. (MINI): to diagnosis psychiatric disorders 4. Symptom checklist 90(SCL 90) 5. Quality of life questionnaire. 6. Hamilton Depression scale. 7. Hamilton Anxiety scale. 8. Socioeconomic scale (A.El.Gilany,A.El.Wehady,and M.EL.Wasify) | Other | – |
Primary outcome
Measurement of depression in couples with IVF .
Time frame: Baseline
Measurement of psychiatric aspects in patients who perform or plan to perform in vitro fertilization by psychometric scales for measurement of depression such as The Hamilton Depression Rating Scale (HAM-D or HDRS) depression scale. * Scores below 7 generally represent the absence or remission of depression. * Scores between 7-17 represent mild depression * Scores between 18-24 represent moderate depression * Scores 25 and above represent severe depression
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 May 2023.
- Background: PubMed 23271957Mascarenhas MN, Flaxman SR, Boerma T, Vanderpoel S, Stevens GA. National, regional, and global trends in infertility prevalence since 1990: a systematic analysis of 277 health surveys. PLoS Med. 2012;9(12):e1001356. doi: 10.1371/journal.pmed.1001356. Epub 2012 Dec 18.
- Background: PubMed 24885428Kocourkova J, Burcin B, Kucera T. Demographic relevancy of increased use of assisted reproduction in European countries. Reprod Health. 2014 May 26;11:37. doi: 10.1186/1742-4755-11-37.
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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.
Dr.Wageh Abd Elnasser contact
Questions about this trial
What is this clinical trial studying?
An observational study of In Vitro Fertilization, run by Assiut University.
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 2 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: status not confirmed, as of the sponsor's last update on 31 May 2023. Status can change between updates, so confirm with the study contact before making plans.
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 Marina Abdelmalak (+2012184658331, marinaabdelmalak02@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Measurement of depression in couples with IVF . (time frame: Baseline). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05881044, which also lists 2 linked publications.
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 31 May 2023.