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Psychiatric and Social Impacts of IVF

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ClinicalTrials.gov Identifier: NCT05881044
Recruitment Status : Not yet recruiting
First Posted : May 30, 2023
Last Update Posted : May 31, 2023
Sponsor:
Information provided by (Responsible Party):
Marina Hanna Abd elmalak bakhet, Assiut University

Study Description
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Brief Summary:
To asses psychiatric impacts of In vitro fertilization.

Condition or disease Intervention/treatment
In Vitro Fertilization Other: Psychiatric interview

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
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Study Type : Observational
Estimated Enrollment : 52 participants
Observational Model: Other
Time Perspective: Cross-Sectional
Official Title: Psychiatric and Social Impacts of In Vitro Fertilization.
Estimated Study Start Date : June 1, 2023
Estimated Primary Completion Date : September 1, 2023
Estimated Study Completion Date : January 1, 2024
Groups and Cohorts
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Intervention Details:
  • Other: Psychiatric interview
    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)

Outcome Measures
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Primary Outcome Measures :
  1. 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


Eligibility Criteria
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Ages Eligible for Study:   18 Years to 40 Years   (Adult)
Sexes Eligible for Study:   All
Sampling Method:   Non-Probability Sample
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)
Criteria

Inclusion Criteria:

  • Couples who perform or planning or failed to perform in vitro fertilization.
  • Age from 18y To 40y .

Exclusion Criteria:

  • 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.
Contacts and Locations
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Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05881044


Contacts
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Contact: Marina Abdelmalak +2012184658331 marinaabdelmalak02@gmail.com
Contact: Dr.Wageh Abd Elnasser +201227432194

Sponsors and Collaborators
Assiut University
More Information
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Publications:

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Responsible Party: Marina Hanna Abd elmalak bakhet, Principal Investigator, Assiut University
ClinicalTrials.gov Identifier: NCT05881044    
Other Study ID Numbers: Impacts of IVF
First Posted: May 30, 2023    Key Record Dates
Last Update Posted: May 31, 2023
Last Verified: May 2023

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No