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Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT05881044
Other study ID # Impacts of IVF
Secondary ID
Status Not yet recruiting
Phase
First received
Last updated
Start date June 1, 2023
Est. completion date January 1, 2024

Study information

Verified date May 2023
Source Assiut University
Contact Marina Abdelmalak
Phone +2012184658331
Email marinaabdelmalak02@gmail.com
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

To asses psychiatric impacts of In vitro fertilization.


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 .


Recruitment information / eligibility

Status Not yet recruiting
Enrollment 52
Est. completion date January 1, 2024
Est. primary completion date September 1, 2023
Accepts healthy volunteers
Gender All
Age group 18 Years to 40 Years
Eligibility 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.

Study Design


Related Conditions & MeSH terms


Intervention

Other:
Psychiatric interview
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)

Locations

Country Name City State
n/a

Sponsors (1)

Lead Sponsor Collaborator
Assiut University

References & Publications (2)

Kocourkova 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. — View Citation

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. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary 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
Baseline
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