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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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12 December 2020 |
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Main ID: |
NCT03348865 |
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Date of registration:
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16/11/2017 |
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Prospective Registration:
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Yes |
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Primary sponsor: |
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Public title:
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Fertility Life Counselling Aid- FeLiCiA
FeLiCiA |
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Scientific title:
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Interventions to Reduce Psychological Interventions Associated With Infertility in Nigeria. |
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Date of first enrolment:
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November 20, 2017 |
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Target sample size:
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16 |
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Recruitment status: |
Completed |
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URL:
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https://clinicaltrials.gov/show/NCT03348865 |
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Study type:
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Interventional |
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Study design:
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Allocation: Randomized. Intervention model: Factorial Assignment. Primary purpose: Supportive Care. Masking: Single (Outcomes Assessor).
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Phase:
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N/A
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Countries of recruitment
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Nigeria
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Contacts
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Name:
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Abiola O Aiyenigba, PhD Student |
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Address:
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Telephone:
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Email:
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Affiliation:
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University of Liverpool |
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Key inclusion & exclusion criteria
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Inclusion Criteria:
1. All consenting Patients aged between 21 and 45 years attending the infertility
outpatient clinics, the Assisted Reproduction clinics and other gynecological,
andrology and nephrology clinics for infertility treatment
2. Patients who have been undergoing infertility treatments for over 2 years.
3. Patients who also have a GHQ 12 score of 3 or more.
4. Patients who have been identified having mild to moderate anxiety and/or depression
using the psychometric measuring tools that would not qualify to be treated
bio-medically.
Exclusion Criteria:
1. Non-consenting patients aged between 21 and 45 years attending the infertility
outpatient clinics, the Assisted Reproduction clinics and other gynecological,
andrology and nephrology clinics for infertility treatment.
2. Participants with infertility for less than two years.
3. Participants identified as having severe forms of anxiety and depression that require
urgent psychiatric treatments/referral.
4. Patients who have previously been clinically diagnosed and treated for with a mental
illness.
Age minimum:
21 Years
Age maximum:
45 Years
Gender:
All
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Health Condition(s) or Problem(s) studied
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Anxiety Disorders
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Psychological Distress
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Infertility/Sterility
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Depressive Disorder
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Psychological Stress
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Intervention(s)
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Behavioral: Fertility Life Counselling Aid (FeLiCiA)
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Primary Outcome(s)
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Measurement for absence of psychological morbidities post intervention
[Time Frame: 6 weeks]
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Secondary Outcome(s)
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Measurement for sustained absence of psychological morbidities, 6months post intervention
[Time Frame: 6 months]
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Explore patient perspective on benefits of intervention using qualitative methods, post intervention.
[Time Frame: 6 weeks]
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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