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The effect of counseling based on acceptance and commitment consulting on perceived stress, number of ‎oocytes retrieved and pregnancy rates in infertile women undergoing IVF treatments

Protocol summary

Study aim
Determination effect of counseling based on acceptance and commitment consulting on perceived stress, number of ‎oocytes retrieved and pregnancy rates in infertile women undergoing IVF treatments
Design
Two-group randomized clinical trial on 76 women eligible for randomized study through www.randomization.com
Settings and conduct
Samples will be selected from among infertile women who are eligible to enter the intervention. Then, for random assignment of samples to the intervention and control groups, the permutation block method will be used, which this method uses random software. Allocation Software is performed and randomly places one person in the intervention group and one person in the control group., In Milad Infertility Center, Mashhad
Participants/Inclusion and exclusion criteria
Diagnosis of primary infertility, age between 20 and 40 years, the couple has no children or adopted children, is being treated for IVF for the first time, has a normal view of ovarian base on ultrasound to start treatment, has a normal spermogram, has a smartphone.
Intervention groups
The intervention group will conduct six sessions of 45-60 minutes, individually, in person and the rest of the sessions in absentia every six days. The control group receives only the usual services of the center.
Main outcome variables
Stress, number of eggs taken and pregnancy rate

General information

Reason for update
Acronym
ACT
IRCT registration information
IRCT registration number: IRCT20210510051249N1
Registration date: 2021-08-25, 1400/06/03
Registration timing: prospective

Last update: 2021-08-25, 1400/06/03
Update count: 0
Registration date
2021-08-25, 1400/06/03
Registrant information
Name
Toktam sadat Taheri
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 51 3859 1511
Email address
taherits971@mums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2021-09-06, 1400/06/15
Expected recruitment end date
2022-01-20, 1400/10/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of counseling based on acceptance and commitment consulting on perceived stress, number of ‎oocytes retrieved and pregnancy rates in infertile women undergoing IVF treatments
Public title
The effect of counseling on perceived stress, number of ‎oocytes retrieved and pregnancy rates
Purpose
Education/Guidance
Inclusion/Exclusion criteria
Inclusion criteria:
Diagnosis of primary infertility, Iranian and resident of Mashhad, ability to speak and write in Persian, no known medical diseases, age between 20 to 40 years, couple have no children or adopted children, no mental illness, IVF treatment for For the first time, in the basic ultrasound (day 2 to 3 of the cycle) the ovary has a normal appearance to start treatment, the spermogram is normal, the husband has no other spouse, no smoking and alcohol consumption, BMI is below 30, IVF candidate, has Smartphone and consent to participate in the study
Exclusion criteria:
Intend to use embryos and donated eggs or surrogates
Age
From 20 years old to 40 years old
Gender
Female
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size: 76
Randomization (investigator's opinion)
Randomized
Randomization description
Sampling is available by simple random assignment. After determining the sample size, through a table of random numbers using the statistical software Random allocation software, the numbers are divided into two groups of sequences marked with the letters A and B. The sequence stored in sealed envelopes that the researcher uses when selecting a research unit to send individuals to two groups that meet the inclusion criteria.
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethics committee Mashhad University of Medical Sciences and Health Services
Street address
Opposite to University Street 18, University Street, Mashhad University of Medical Sciences, Khorasan Razavi, Iran
City
Mashhad
Province
Razavi Khorasan
Postal code
9188667656
Approval date
2021-06-15, 1400/03/25
Ethics committee reference number
IR.MUMS.NURSE.REC.1400.032

Health conditions studied

1

Description of health condition studied
The effect of counseling based on acceptance and commitment consulting on perceived stress number of ‎oocytes retrieved and pregnancy rates in infertile women undergoing IVF treatments
ICD-10 code
ICD-10 code description

Primary outcomes

1

Description
Stress score
Timepoint
The beginning of the study (before the intervention) and the trigger day (two weeks after the last consultation) and two weeks after the embryo transfer
Method of measurement
Newton Infertility Stress Questionnaires

Secondary outcomes

1

Description
Follicle number
Timepoint
Number of ovarian follicles at trigger time with HCG
Method of measurement
With ultrasound by a gynecologist

2

Description
pregnancy rates
Timepoint
Two weeks after embryo transfer
Method of measurement
blood test

Intervention groups

1

Description
The intervention group will receive six sessions of 45-60 minutes, counseling based on acceptance and commitment individually, the first session of day 2 to 3 of the first cycle (after basic ultrasound) in person and the rest of the sessions in absentia every six days ( Day 8- 14-20-26 The first cycle and the last session will be run on days 2 to 3 of the next virtual cycle
Category
Behavior

2

Description
Control group: In the first session, the control group completes the questionnaires and provides the routine services of the center, which include explanations about IVF treatment and possible complications and costs for treatment, to decide on treatment. On day 2-3 of the cycle, measures including basic ultrasound and initial tests are requested and then 21 units of subcutaneous ampoules of Cinnafact are prescribed daily for 0.5 units, and they are taught how to use infertility drugs and the time of their next visit. Second, HMG 150-300 units are added daily depending on the ovarian reserve under the supervision of an infertility specialist and 6 days after the onset of ovarian stimulation, folliculography is performed every two to three days, until at least 3 dominant 17 mm follicles are observed. HCG is triggered and ovulation will occur 36 hours later.
Category
Behavior

Recruitment centers

1

Recruitment center
Name of recruitment center
Milad Infertility Clinic, Mashhad
Full name of responsible person
Nahid jahani shorab
Street address
School of Nursing and Midwifery, Ibn Sina St., Doctora Intersection, Daneshgah St., Mashhad, Khorasan Razavi, Iran
City
mashhad
Province
Razavi Khorasan
Postal code
9137913199
Phone
+98 51 3859 1511
Fax
+98 51 3859 7313
Email
jahanishn@mums.ac.ir

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Dr. Mohammad Reza Darabi Mahboob
Street address
Opposite to University Street 18, University Street Mashhad University of Medical Sciences, Khorasan Razavi, Iran
City
Mashhad
Province
Razavi Khorasan
Postal code
91357-345
Phone
+98 51 3841 3007
Fax
+98 51 3841 3006
Email
Bahreynimh@mums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Mashhad 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
Mashhad University of Medical Sciences
Full name of responsible person
Toktam taheri
Position
Student
Latest degree
Bachelor
Other areas of specialty/work
Midwifery
Street address
University Street, Ph.D. Crossroads, School of Nursing and Midwifery
City
Mashhad
Province
Razavi Khorasan
Postal code
9189835486
Phone
+98 51 3859 1511
Email
taherits971@mums.ac.ir

Person responsible for scientific inquiries

Contact
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Nahid Jahani Shorab
Position
Master
Latest degree
Master
Other areas of specialty/work
Midwifery
Street address
School of Nursing and Midwifery, Ibn Sina St., Doctora Intersection, Daneshgah St., Mashhad, Khorasan Razavi, Iran
City
Mashhad
Province
Razavi Khorasan
Postal code
9137913199
Phone
+98 51 3859 1511
Fax
+98 51 3859 7313
Email
jahanishn@mums.ac.ir

Person responsible for updating data

Contact
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Toktam taheri
Position
Student
Latest degree
Bachelor
Other areas of specialty/work
Midwifery
Street address
University Street, Ph.D. Crossroads, School of Nursing and Midwifery
City
mashhad
Province
Razavi Khorasan
Postal code
9189835486
Phone
0095138595668
Email
taherits971@mums.ac.ir

Sharing plan

Deidentified Individual Participant Data Set (IPD)
Undecided - It is not yet known if there will be a plan to make this available
Study Protocol
Undecided - It is not yet known if there will be a plan to make this available
Statistical Analysis Plan
Undecided - It is not yet known if there will be a plan to make this available
Informed Consent Form
Undecided - It is not yet known if there will be 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
Undecided - It is not yet known if there will be a plan to make this available
Data Dictionary
Undecided - It is not yet known if there will be a plan to make this available
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