A Comparative Investigation of The Effect of Auriculotherapy and Spiritual Health Promotion Enriched with Cognitive Behavioral Techniques on The Quality of Sperm and Fertility Rate in Infertile Couples Undergoing Intrauterine Sperm Insemination (IUI) Treatment in Infertility Centers
Determining the Comparative Effect of Auriculotherapy and Spiritual Health Promotion Enriched with Cognitive Behavioral Techniques on Sperm Quality and Fertility rate in Infertile Couples undergoing Intrauterine Insemination Treatment (IUI) in Infertility Centers
Design
The Present Study Is a Randomized Controlled Clinical Trial Study on all Infertile Couples Who are Candidates for Intrauterine Sperm Insemination (600 couples), Who are Treated with Intrauterine Sperm Insemination. The Number of Follicles and Thickness of the Endometrium Were Checked in the Uterus and Ovaries on Days 1 To 3 of the Menstrual Cycle Using an Ultrasound Machine. After Taking the Semen Sample in the Infertility Center Laboratory, It Was Collected in a Sterile Container and at a Suitable Temperature, about 30 to 45 Minutes Was Considered for Liquefaction, Then It Was Analyzed with A Computerized Sperm Analysis Device.
Settings and conduct
The Present Study Is a Clinical Trial Study That Was Conducted on Infertile Women in Public and Private Infertility Centers of Kerman University of Medical Sciences. Randomization Was Done Based on Random Block Method and Blinding Was Not Done.
Participants/Inclusion and exclusion criteria
Infertile Couples Suffering from Primary Infertility who referred to Infertility centers in Kerman City
Intervention groups
Candidates for Intrauterine Sperm Insemination Treatment who are Eligible to enter the study will be assigned to one of three groups (Auriculotherapy, Spiritual Therapy and control) with a ratio of 1:1:1 in the form of one of the 6 Blocks.
Main outcome variables
Sperm quality; Fertility rate
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20170611034452N18
Registration date:2024-06-02, 1403/03/13
Registration timing:registered_while_recruiting
Last update:2024-06-02, 1403/03/13
Update count:0
Registration date
2024-06-02, 1403/03/13
Registrant information
Name
Atefeh Ahmadi
Name of organization / entity
Kerman University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 34 3132 5205
Email address
a.ahmadi@kmu.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2024-04-19, 1403/01/31
Expected recruitment end date
2024-12-19, 1403/09/29
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
A Comparative Investigation of The Effect of Auriculotherapy and Spiritual Health Promotion Enriched with Cognitive Behavioral Techniques on The Quality of Sperm and Fertility Rate in Infertile Couples Undergoing Intrauterine Sperm Insemination (IUI) Treatment in Infertility Centers
Public title
Comparison Of the Effect of Auriculotherapy and Spiritual Health Promotion Enriched with Cognitive Behavioral Techniques on Sperm Quality and Fertility Rate in Infertile Couples Undergoing Intrauterine Sperm Insemination Treatment.
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Age 20-40 Years
Having Minimum Literacy in Reading and Writing
Iranian Nationality
Primary Infertility with A Male Factor Related to The Reduction of Sperm Quality and A Candidate For IUI
Absence Of Uterine Structure Disorders
Not Suffering from Systemic Diseases
The First Marriage of Each Couple
Ability To Participate in Group Therapy Sessions
Not Suffering from Other Causes of Female Infertility Except Ovulation
At Least One Year Has Passed in Couples Less Than 35 Years Old Since the Diagnosis of Infertility
At Least 6 Months Have Passed Since the Diagnosis of Infertility in Couples Over 35 Years Old
Willingness To Consciously Participate in Research
Not Having Strong Emotional Emotions During the Last 6 Months
The Lack of Education of Each of The Spouses in The Fields of Psychology and Theology.
Non-Participation of Each of The Spouses in Seminary Courses or Spiritual-Religious Training Workshops
Not Having Adopted Children
Not Using Acupuncture or Pressure Methods During the Last 3 Months.
Having At Least One Healthy ear
Exclusion criteria:
Impaired Recognition of Psychological Conditions During Study, Such as Severe Depression
Being Addicted to Drugs While Studying
Having an Ear Infection While Studying in The Auriculotherapy Group
Failure to Use the Correct Placement of Seeds
Non-Participation and Cooperation In 2 Sessions Will Be During the Study
Suffering from Sexually Transmitted Diseases During the Study
Occurrence of Any Severe Family Dispute or Unfortunate Incident During Treatment
History of Using Other Assisted Reproductive Methods
Age
From 20 years old to 40 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
60
Randomization (investigator's opinion)
Randomized
Randomization description
Allocating The Samples to Three Control Groups, The Auriculotherapy Group and The Counseling Group of Spiritual Therapy and Cognitive Behavioral Techniques Were Assigned in A Randomized Controlled Manner. Randomization Was Done Based on The Random Block Method Using the link https://www.sealedenvelope.com/simple-randomiser/v1/lists.
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
Research Ethics Committees of Kerman University of Medical Sciences
Street address
Kerman University of Medical Sciences, Medical University campus. Haft. Bagh Highway, Kerman, Iran Kerman
City
Kerman
Province
Kerman
Postal code
7616913555
Approval date
2024-01-16, 1402/10/26
Ethics committee reference number
IR.KMU.REC.1402.444
Health conditions studied
1
Description of health condition studied
Infertility Treatment
ICD-10 code
N97.0
ICD-10 code description
Female infertility associated with anovulation
Primary outcomes
1
Description
Sperm Quality
Timepoint
Sperm Quality Check, in Addition to before the Intervention, Immediately After the Intervention and 3 Months After the End of the Intervention and Check the Fertility Rate based on the Positive Result of the Pregnancy Test That Was Completed 2 Weeks After the IUI and Monthly Follow-Up for a Period of 3 Months for All Three Groups.
Method of measurement
Questionnaire, Spermogram
Secondary outcomes
1
Description
Fertility Rate
Timepoint
3 Months
Method of measurement
Based on the Positive Result of the Pregnancy Test
Intervention groups
1
Description
Intervention group: In the Auriculotherapy Group, the Method of Intervention is as Follows: Vacaria Plant Seeds Were Placed in the Corresponding Points in the Right And Left Ears. Sids Are One of the Required Devices of Auriculotherapy in Our Research, Which are Placed In Certain Places of the Ear by Means of Adhesives That are Not Easily Removed. These Adhesives do not React To Body Oil and are not Easily Removed from the Ear. Each Auriculotherapy Session Lasts Approximately 30 Minutes with Full Explanations for the Participants. During Which, in the Relevant Points, for 10 to 15 Seconds, Using the Vakaria Syds, These Syds Were Placed on Certain Points of the Participant's Ear. Then the Participants were asked to press the Points Every Hour For one Minute at Home for A Week, There is no Need to Press The Points At Night While Sleeping. They Should Come Next Week To Change The Vacaria Tires.
Category
Treatment - Devices
2
Description
Intervention group:
Category
Behavior
3
Description
Control group: In the Control Group, in the Last Counseling Session, a Counseling Package was Provided to the Couples to Inform Them, and During Counseling, Telephone Follow-Up was Done to Check The Conditions of Withdrawal from the Study.
Category
Treatment - Other
Recruitment centers
1
Recruitment center
Name of recruitment center
Public and Private Infertility Centers of Kerman University of Medical Sciences
Full name of responsible person
Masoumeh Ghazanfarpour
Street address
Kerman University of Medical Sciences, Medical University campus. Haft. Bagh Highway, Kerman, Iran Kerman
City
Kerman
Province
Kerman
Postal code
7616913555
Phone
+98 34 3132 5700
Email
m.ghazanfarpour@kmu.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Kerman University of Medical Sciences
Full name of responsible person
Abedin Iranpour
Street address
Kerman University of Medical Sciences, Medical University campus. Haft. Bagh Highway, Kerman, Iran Kerman
City
Kerman
Province
Kerman
Postal code
7616913555
Phone
+98 34 3132 5700
Email
m.ghazanfarpour@kmu.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
No
Title of funding source
Research Vice-Chancellor of Kerman 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
Kerman University of Medical Sciences
Full name of responsible person
Masoumeh Ghazanfarpour
Position
Associate professor
Latest degree
Ph.D.
Other areas of specialty/work
Reproductive Health
Street address
Kerman University of Medical Sciences, Medical University campus. Haft. Bagh Highway, Kerman, Iran Kerman
City
Kerman
Province
Kerman
Postal code
7616913555
Phone
00983
Email
m.ghazanfarpour@kmu.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Kerman University of Medical Sciences
Full name of responsible person
Masoumeh Ghazanfarpour
Position
Associate professor
Latest degree
Ph.D.
Other areas of specialty/work
Reproductive Health
Street address
Kerman University of Medical Sciences, Medical University campus. Haft. Bagh Highway, Kerman, Iran Kerman
City
Kerman
Province
Kerman
Postal code
7616913555
Phone
+98 34 3132 5700
Email
m.ghazanfarpour@kmu.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Kerman University of Medical Sciences
Full name of responsible person
Masoumeh Ghazanfarpour
Position
Associate professor
Latest degree
Ph.D.
Other areas of specialty/work
Reproductive Health
Street address
Kerman University of Medical Sciences, Medical University campus. Haft. Bagh Highway, Kerman, Iran Kerman
City
Kerman
Province
Kerman
Postal code
7616913555
Phone
+98 34 3132 5700
Email
m.ghazanfarpour@kmu.ac.ir
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
Yes - There is a plan to make this available
Informed Consent Form
Yes - There is a plan to make this available
Clinical Study Report
Yes - There is a plan to make this available
Analytic Code
Yes - There is a plan to make this available
Data Dictionary
Yes - There is a plan to make this available
Title and more details about the data/document
All Collected Deidentified IPD
When the data will become available and for how long
starting 6 Months after Publication
To whom data/document is available
People Working in Academic Institutions
Under which criteria data/document could be used
with previous agreement with the corresponding author
From where data/document is obtainable
Corresponding Author, Email Address
What processes are involved for a request to access data/document