This study will be done with aim to investigate the effectiveness and non-effectiveness of McMaster-based intervention models on family function in infertile couples. This is not blind clinical trial. The study population will be consisted of all infertile couples undergoing IUI (Intrauterine insemination) referred to the Moatazedi Infertility Center of Kermanshah city that 40 eligible infertile women will be selected in available method and randomly will be assigned in to tow experimental and control groups.Baseline McMaster family functioning (FAD) questionnaire will be provided to both groups. Intervention group four 60-90 minutes training sessions will receive McMaster family functioning Training(including group discussions, lectures and use of educational booklets) weekly during a month. The control group will not receive any training. A month after the end of the study Family functioning Questionnaire will be provided to both groups and both groups will be compared.
Inclusion criteria: Diagnosis of infertility with the approval of Obstetricians and Gynecologists of center; Lack of hard physical illness; No known psychiatric problems based on patient records; Lack of drug addiction; Least guidance level; Living in Kermanshah.
Exclusion criteria: Dissatisfaction to the continuation of cooperation in research; Partially completed questionnaires and the absence of more than one session in the training program.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2017053014333N76
Registration date:2017-06-11, 1396/03/21
Registration timing:prospective
Last update:
Update count:0
Registration date
2017-06-11, 1396/03/21
Registrant information
Name
Feizollah Foroughi
Name of organization / entity
kermanshah University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 83 1821 4653
Email address
fforoughi@kums.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice Chancellor for Research Affairs, Kermanshah University of Medical Sciences
Expected recruitment start date
2017-06-15, 1396/03/25
Expected recruitment end date
2017-08-16, 1396/05/25
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Investigation the effectiveness and non-effectiveness of McMaster-based intervention models on family function in infertile couples
Public title
Investigation the effectiveness of family function intervention training in infertile couples
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: Diagnosis of infertility with the approval of Obstetricians and Gynecologists of center; Lack of hard physical illness; No known psychiatric problems based on patient records; Lack of drug addiction; Least guidance level; Living in Kermanshah
Exclusion criteria: Dissatisfaction to the continuation of cooperation in research; Partially completed questionnaires and the absence of more than one session in the training program.
Age
From 20 years old to 43 years old
Gender
Male
Phase
1-2
Groups that have been masked
No information
Sample size
Target sample size:
40
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Randomly by tossing coin
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Kermanshah University of Medical Sciences
Street address
Building No.2, Shahid Beheshti, Vice Chancellor for Research Affairs, Kermanshah University of Medical Sciences
City
Kermanshah
Postal code
Approval date
2017-05-17, 1396/02/27
Ethics committee reference number
kums.rec.1396.82
Health conditions studied
1
Description of health condition studied
Infertility
ICD-10 code
N97
ICD-10 code description
Female infertility
Primary outcomes
1
Description
Family function
Timepoint
Baseline and one month after the end of the study
Method of measurement
According to McMaster Family Questionnaire (FAD)
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group four 60-90 minutes training sessions will receive McMaster family functioning Training(including group discussions, lectures and use of educational booklets) weekly during a month.
Category
Behavior
2
Description
The control group will not receive any training
Category
Other
Recruitment centers
1
Recruitment center
Name of recruitment center
Infertility Clinic Hospital Moatazedi
Full name of responsible person
Farkhondeh Ashtarian
Street address
Ferdowsi Square
City
Kermanshh
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice chancellor for research, Kermanshah University of Medical Sciences
Full name of responsible person
Koroush Hamzehee
Street address
Building No.2, Shahid Beheshti, Vice Chancellor for Research Affairs, Kermanshah University of Medical Sciences
City
Kermanshah
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Vice chancellor for research, Kermanshah University of Medical Sciences
Proportion provided by this source
100
Public or private sector
empty
Domestic or foreign origin
empty
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
empty
Person responsible for general inquiries
Contact
Name of organization / entity
Kermanshah University of Medical Sciences
Full name of responsible person
Farkhondeh Ashtarian
Position
MA Student of consultation in midwifery
Other areas of specialty/work
Street address
School of Nursing & Midwifery, First of Dolatabad Boulvard, Eisar Square
City
Kermanshah
Postal code
Phone
+98 83 3827 9394
Fax
Email
f.ashtarian@yahoo.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Kermanshah University of Medical Sciences
Full name of responsible person
Dr. Marzieh Kaboudi
Position
Ph.D. in Reproductive Health
Other areas of specialty/work
Street address
School of Nursing & Midwifery, First of Dolatabad Boulvard, Eisar Square
City
Kermanshah
Postal code
Phone
+98 83 3827 9394
Fax
Email
kaboudim@gmail.com
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Kermanshah University of Medical Sciences
Full name of responsible person
Farkhondeh Ashtarian
Position
MA Student of consultation in midwifery
Other areas of specialty/work
Street address
School of Nursing & Midwifery, First of Dolatabad Boulvard, Eisar Square
City
Kermanshah
Postal code
Phone
+98 83 3827 9394
Fax
Email
f.ashtarian@yahoo.com
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)