Determining the effectiveness of health promotion lifestyle training program in infertile couples candidates for assisted reproductive technologies.
Design
A blocked randomized parallel design clinical trial conducted by random numbers obtained from the site (www.randomization.com). Randomization in quadratic blocks is then performed on 150 pairs of candidates for assisted reproductive technology.
Settings and conduct
The clinical trial will be a hospitals in Tehran. Patients will be blinded and screened by sealed envelopes.The assigned numbers are placed in the envelope and are assigned upon the patient's arrival.
Participants/Inclusion and exclusion criteria
Inclusion criteria:
1-Interested in participate in the study
2- Infertile couples are candidates for Assisted Reproductive Technologies
3- Could read and write
4- First or second time of fertility treatment
Exclusion criteria:
1- Any mental or psychotic disorder
2-Any chronic diagnosed illness,
Intervention groups
The intervention group will receive a training program related to lifestyle enhancement in the field of aerobic physical activity by walking, Mediterranean diet modification and stress management with mindfulness. The control group will receive training on breastfeeding.
Main outcome variables
1- Primary outcome of chemical pregnancy diagnosed by beta human chronic gonadothrophin ( B-hCG blood test).
2- clinical pregnancy (Diagnose heart beat at 6 weeks by ultrasound), .
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20190529043754N1
Registration date:2022-03-29, 1401/01/09
Registration timing:prospective
Last update:2022-03-29, 1401/01/09
Update count:0
Registration date
2022-03-29, 1401/01/09
Registrant information
Name
Padideh Malekpour
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 21 4421 4300
Email address
malekpour@shmu.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2022-04-09, 1401/01/20
Expected recruitment end date
2022-08-11, 1401/05/20
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Determining the effectiveness of a health-promoting lifestyle training program in infertile couples under Assisted Reproductive Technologies (ART).
Public title
The effect of health promoting lifestyle educational program on infertile couple who candidate for Assisted reproductive technology.
Purpose
Education/Guidance
Inclusion/Exclusion criteria
Inclusion criteria:
Interested in participating in the study,
Assisted Reproductive Technology candidate couples
Could read and write
First or second infertility Treatment,
Exclusion criteria:
Diagnosed for mental or psychotic disorders
Diagnosed for Chronic illnesses
Age
From 18 years old to 40 years old
Gender
Both
Phase
N/A
Groups that have been masked
Participant
Data analyser
Sample size
Target sample size:
150
More than 1 sample in each individual
Number of samples in each individual:
75
There will be 75 people in the intervention group and 75 in control group.
Randomization (investigator's opinion)
Randomized
Randomization description
After primary selection, the samples will be divided into two groups by simple sampling method, using a random block of 4, with an allocation ratio of 1: 1. Then, by listing all the Possible mods of blocks of 4 and assign numbers to each of them, with use computer random numbers with 1:1 allocation ratios, Participants will be divided into two groups of intervention and control.
Community Verified icon
Blinding (investigator's opinion)
Double blinded
Blinding description
The sequence is provided to the researcher by a statistical consultant using a website. Then sealed envelope will be used According to the sequence produced, the blocks are designed and placed in closed envelopes. As soon as the eligible patient enters, the envelopes are opened in order and According to the letter.هside them, they will assigned to one of the groups' treatment or control. Patient information will recorded by the research team.
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee of Shahroud University of Medical Sciences
Street address
Sharoud medical science and health service university, Hafte tir square, Shahroud, Iran.
City
Shahroud
Province
Semnan
Postal code
۳۶۱۴۷-۷۳۹۴۳
Approval date
2020-04-20, 1399/02/01
Ethics committee reference number
IR.SHMU.REC.1399.008
Health conditions studied
1
Description of health condition studied
Infertility
ICD-10 code
N97
ICD-10 code description
Female infertility
Primary outcomes
1
Description
Primary outcome: Chemical pregnancy by Beta human chronic gonadotrophin (B-hCG) blood test.
Timepoint
4 and 6 week after pregnancy
Method of measurement
Blood test to diagnose pregnancy by (Beta-hCG) test
2
Description
Clinical pregnancy (diagnosis of fetal heart rate at 6 weeks with ultrasound)
Timepoint
Weeks 4 and 6 of pregnancy
Method of measurement
Hearing the sound of the fetal heart during the 6th week of pregnancy by ultrasound
Secondary outcomes
1
Description
Live Birth
Timepoint
Delivery after 24 week of pregnancy
Method of measurement
Neonate delivered via natural or cesarean
Intervention groups
1
Description
Intervention group: The intervention group will included 75 infertile couples (men and women) undergoing infertility treatments.The training program will be in three dimensions. 1- physical activity: The intervention group will perform physical activity home-based exercise and balanced walking with progressive muscle relaxation. in the end of activity they will do deep diaphragmatic breathing. exercise. Pattern of activity will be 3 times a week, for 45 minutes, In moderate intensity in 8 sessions before the onset of ovulation stimulation. Diet: In the intervention group, nutrition will include adjusting calorie intake based on participants' body mass index classification along with receiving the standard 5 main food groups with Mediterranean diet in 8 sessions before the onset of ovulation stimulation. The food frequency questionnaire will be completed. Stress management: In the intervention group, stress management will be based on the Mindfulness program. Training and counseling sessions will be held in personally and virtually for 8 sessions of 60 minutes, once a week.The content of the sessions begins with an introduction and welcome, then will continue to introduce stress and the mechanism of the effect of stress on the body, familiarity with the reproductive system, causes of infertility and infertility treatment methods. Training in the next sessions will include progressive muscle relaxation, ecstasy, diaphragmatic breathing, self-help, strengthening self-reconciliation, recognizing strengths and weaknesses, problem solving, forgiving oneself and others, compassion for oneself and others, sharing experiences. Training will be done 6 sessions before the onset of ovulation and 2 sessions in the waiting period until the pregnancy test is positive. Pr-test and post-test will perform.
Category
Lifestyle
2
Description
Control group: 75 infertile under treatment couples in the control group will receive lactation education.
Category
Lifestyle
Recruitment centers
1
Recruitment center
Name of recruitment center
Akbarabadi Hospital
Full name of responsible person
Dr.Mozhghan Javedani
Street address
Akbarabadi hospital, Ferdos garden station, Not reached to molavi crossroad, Molavi street.Tehran, Iran
City
Tehran
Province
Tehran
Postal code
کد پستی: ۱۱۶۸۷۴۳۵۱۴
Phone
+98 21 5560 6034
Email
javedani46@yahoo.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Shahroud University of Medical Sciences
Full name of responsible person
Dr.Mohammad Hassan Emamian
Street address
Vice Chancellor for Research, Medical science of sharoud university, Hafte tir Squer, Shahroud, Iran.
City
Shahroud
Province
Semnan
Postal code
۳۶۱۴۷-۷۳۹۴۳
Phone
+98 23 3239 4499
Email
pajouhesh@shmu.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
No
Title of funding source
Vice chancellor for research, Shahroud University of medical sciences.
Proportion provided by this source
100
Public or private sector
Public
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Academic
Person responsible for general inquiries
Contact
Name of organization / entity
Shahroud University of Medical Sciences
Full name of responsible person
Padideh Malekpour
Position
PhD candidate for Reproductive health
Latest degree
Ph.D.
Other areas of specialty/work
Midwifery
Street address
Shahroud University of Medical Sciences, Hafte Tir Square, Shahroud, Iran
City
Shahroud
Province
Semnan
Postal code
۳۶۱۴۷-۷۳۹۴۳
Phone
4 +98 23 3234 2000
Email
padideh_66@yaoo.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Shahroud University of Medical Sciences
Full name of responsible person
Dr.Zahra Motaghi
Position
Reproductive health specialist
Latest degree
Ph.D.
Other areas of specialty/work
Midwifery
Street address
Shahroud University of Medical Sciences and Health Service building, Hafte Tir Square,, Shahroud, Iran.
14535, Iran medical science university building, Next to Milad Tower، Hemat Highway, Tehran, Iran
City
Tehran
Province
Tehran
Postal code
۳۶۱۴۷-۷۳۹۴۳
Phone
+98 21 5563 7048
Email
javedani46@yahoo.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Yes - There is a plan to make this available
Study Protocol
Yes - There is a plan to make this available
Statistical Analysis Plan
Not applicable
Informed Consent Form
Yes - There is a plan to make this available
Clinical Study Report
Undecided - It is not yet known if there will be a plan to make this available
Analytic Code
No - There is not a plan to make this available
Data Dictionary
No - There is not a plan to make this available
Title and more details about the data/document
The data can be published after the completion of the dissertation
When the data will become available and for how long
One year after completing the dissertation
To whom data/document is available
Shahroud University of Medical Sciences; Hospital and university researchers
Under which criteria data/document could be used
Data will be available after publication in journals
From where data/document is obtainable
Padideh Malekpour
padideh_66@yahoo.com
Correspondence Address: Shahroud University of Medical Sciences, Hafte Tir Square, Shahroud, Iran
Phone: 023-32395054
What processes are involved for a request to access data/document
The information will be available through the publication
of the article. But if more information is needed, the
request should be sent via email