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Evaluation of effectiveness and side effects of intrauterine insemination catheter with mandrel, a product of Slamtyar Hakim engineering company, in infertile couples

Protocol summary

Study aim
Determining the effectiveness and side effects of intrauterine insemination catheter with mandrel, a product of Slamtyar Hakim engineering company, in infertile couples
Design
A randomized Controlled Trial, with parallel groups, 60 patients , and without blinding. The patients randomly assigned to two groups using a random permutation block design
Settings and conduct
This is a concurrent parallel randomized controlled trial. This study will be performed in Shahid Beheshti Hospital (Isfahan) and without blinding. A total of 60 infertile couples will included in the study and randomly assigned into 2 groups of intervention and control. After intrauterine insemination, the first pregnancy test will be done about 2 weeks later to determine the status of chemical pregnancy. One month later, with an ultrasound and detection of fetal heartbeat, clinical pregnancy will be confirmed.
Participants/Inclusion and exclusion criteria
Inclusion criteria: Having 2 to 3 follicles of suitable size, open tubes, acceptable sperm test for intrauterine insemination Exclusion criteria: Age over 42 years, bilateral tubular obstruction, couples with sperm concentration less than ten million spermatozoa per millilitre
Intervention groups
Control group: 30 patients, a catheter without mandrel, produced by Salamatyar Hakim engineering Company, will be used for intrauterine insemination of sperm. Intervention group: 30 patients, a catheter with mandrel, produced by Salamatyar Hakim engineering Company, will be used for intrauterine insemination of sperm.
Main outcome variables
Primary outcomes: Problem with catheter insertion, Need to Tenaculum, Need for cervical dilatation Secondary outcomes: Chemical pregnancy rate, Clinical pregnancy rate

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20160703028756N6
Registration date: 2021-10-13, 1400/07/21
Registration timing: retrospective

Last update: 2021-10-13, 1400/07/21
Update count: 0
Registration date
2021-10-13, 1400/07/21
Registrant information
Name
Elham Naghshineh
Name of organization / entity
Yazd Research and Clinical Center for Infertility
Country
Iran (Islamic Republic of)
Phone
+98 35 3824 7085
Email address
naghshineh@med.mui.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2020-06-21, 1399/04/01
Expected recruitment end date
2021-04-21, 1400/02/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Evaluation of effectiveness and side effects of intrauterine insemination catheter with mandrel, a product of Slamtyar Hakim engineering company, in infertile couples
Public title
Evaluation of intrauterine insemination (IUI) catheter (Mandrel contain) in infertile couples
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Having 2 to 3 follicles of suitable size, open tubes acceptable sperm test for intrauterine insemination
Exclusion criteria:
Age over 42 years bilateral tubular obstruction couples with sperm concentration less than ten million spermatozoa per millilitre
Age
To 42 years old
Gender
Female
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size: 60
Randomization (investigator's opinion)
Randomized
Randomization description
The method of assigning samples to groups is in the form of two-treatment permutation block design with quadruple blocks. Thus, the letter A is considered for the masstec catheter group with mandrel and the letter B for the catheter group without mandrel. Then we write all the permutation compounds of the letters A, A, B, B, which are 6 different compounds, then we choose a number from the digits 1 to 6. For example, if the number 2 is selected, it means that the first person in the intervention group, the next two people in the control group and the fourth person in the intervention group. This operation continues until the sample size reaches the quorum.
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 of Isfahan University of Medical Sciences
Street address
Deputy of research and technology, Isfahan University Of Medical Sciences, Hezarjerib St.
City
Isfahan
Province
Isfehan
Postal code
81746-73461
Approval date
2021-05-29, 1400/03/08
Ethics committee reference number
IR.MUI.MED.REC.1400.158

Health conditions studied

1

Description of health condition studied
Female infertility
ICD-10 code
N97
ICD-10 code description
Female infertility

Primary outcomes

1

Description
Problem with catheter insertion
Timepoint
At the time of intrauterine insemination
Method of measurement
Questionnaire

2

Description
Need to Tenaculum
Timepoint
At the time of intrauterine insemination
Method of measurement
Questionnaire

3

Description
Need for cervical dilatation
Timepoint
At the time of intrauterine insemination
Method of measurement
Questionnaire

Secondary outcomes

1

Description
Chemical pregnancy rate
Timepoint
2 weeks after intrauterine insemination
Method of measurement
Human chorionic gonadotropin Test

2

Description
Clinical pregnancy rate
Timepoint
5 weeks after intrauterine insemination
Method of measurement
Sonography

Intervention groups

1

Description
Control group:In the control group, including 30 patients, the catheter without mandrel, produced by Salamatyar Hakim engineering Company, will be used for intrauterine insemination of sperm.
Category
Treatment - Devices

2

Description
Intervention group: In the intervention group, including 30 patients, the catheter with mandrel, produced by Salamatyar Hakim engineering Company, will be used for intrauterine insemination of sperm.
Category
Treatment - Devices

Recruitment centers

1

Recruitment center
Name of recruitment center
Shahid Beheshti Hospital
Full name of responsible person
Elham Naghshineh
Street address
Shahid Beheshti Hospital, Motahari St, Felezi Bridge, Isfahan, Iran
City
Isfahan
Province
Isfehan
Postal code
8184851153
Phone
+98 31 3236 7001
Email
dr.naghshineh@gmail.com

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Shaghayegh Haghjoo
Street address
Isfahan University Of Medical Sciences, Hezarjerib St., Isfahan, Iran
City
Isfahan
Province
Isfehan
Postal code
۸۱۷۴۶-۷۳۴۶۱
Phone
+98 31 3792 3060
Email
sh_haghjoo@med.mui.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Esfahan University of Medical Sciences
Proportion provided by this source
10
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

2

Sponsor
Name of organization / entity
Salamat Yar Hakim Engineering Co
Full name of responsible person
Sayyed Emran Emami
Street address
Building No. 20, Alley No. 3, South Malek Street, Eight Western Paradise
City
Isfahan
Province
Isfehan
Postal code
8154638871
Phone
+98 31 3273 4080
Email
sayyedemranemami@gmail.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Salamat Yar Hakim Engineering Co
Proportion provided by this source
90
Public or private sector
Private
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Industry

Person responsible for general inquiries

Contact
Name of organization / entity
Poursina Hakim Digestive Diseases Research Center
Full name of responsible person
Fatemeh Maghool
Position
Researcher
Latest degree
Ph.D.
Other areas of specialty/work
Physiology
Street address
No. 12, Yas Block 8, Keshvari Complex, Third Abshar Ave.
City
Isfahan
Province
Isfehan
Postal code
8169333463
Phone
+98 31 9501 6799
Email
fmaghool@gmail.com

Person responsible for scientific inquiries

Contact
Name of organization / entity
Poursina Hakim Digestive Diseases Research Center
Full name of responsible person
Fatemeh Maghool
Position
Researcher
Latest degree
Ph.D.
Other areas of specialty/work
Physiology
Street address
No. 12, Yas Block 8, Keshvari Complex, Third Abshar Ave.
City
Isfahan
Province
Isfehan
Postal code
8169333463
Phone
+98 95016799
Email
fmaghool@gmail.com

Person responsible for updating data

Contact
Name of organization / entity
Poursina Hakim Digestive Diseases Research Center
Full name of responsible person
Fatemeh Maghool
Position
Researcher
Latest degree
Ph.D.
Other areas of specialty/work
Physiology
Street address
No. 12, Yas Block 8, Keshvari Complex, Third Abshar Ave.
City
Isfahan
Province
Isfehan
Postal code
8169333463
Phone
+98 31 9501 6799
Email
fmaghool@gmail.com

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
Yes - There is 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
Title and more details about the data/document
The study protocol, informed consent form, and clinical study report may be shared.
When the data will become available and for how long
Start Access time:4 months after the publication of results
To whom data/document is available
Our data will be available for researchers working in academic and scientific institutions as well as those working in the industry
Under which criteria data/document could be used
The applicant must clearly state the purpose of the requested documentation. Written consent is required for any use of the data.
From where data/document is obtainable
To receive documentation, send your request via the following website: Poursina.masstecmedical.com
What processes are involved for a request to access data/document
After submitting a request, it takes about 7 working days for the application to be received by the applicant.
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