Evaluation of efficiency and side effects of intrauterine insemination (IUI) catheter, a product of Slamtyar Hakim Engineering company, in infertile couples
Determine the efficacy and side effects of intrauterine insemination (IUI) catheter, a product of Slamtyar Hakim Engineering company, in infertile couples
Design
This study is a randomized controlled trial (RCT), a parallel concurrent study. 60 infertile couples will enter this study and continuous sampling method based on the Inclusion and exclusion criteria will be used. The method of assigning samples to the groups is a randomized block design with two blocks of four blocks.
Settings and conduct
Place of study: Shahid Beheshti Hospital and Milad Hospital of Isfahan
In this method, the controlled ovarian stimulation method will be used.All semen samples will be provided within 7-3 days of sexual absenteeism. After the seminal fluid is hydrated, sperm parameters are analyzed according to the World Health Organization (WHO) standards by computerized method.The sperm will be prepared and a small amount of the culture medium will enter the cervix and cavity in the sterile state.The first pregnancy test will be done about 2 weeks later to determine the chemical pregnancy. A month later, clinical pregnancy will be recorded by ultrasound and observation of heartbeat.
Participants/Inclusion and exclusion criteria
The requirement for IUI is to have 2 to 3 follicles of appropriate size, open tubes and acceptable sperm testing for IUI.
Women older than 42 years of age, have a double-sided tubular obstruction problem and men with a sperm concentration of less than 10 million spermatozoa per milliliter are excluded.
Intervention groups
Sixty patients, including two groups of 30, who use IUI catheter ® masstec and the other group uses similar foreign product.
Main outcome variables
1- Occurrence of chemical pregnancy after IUI
2- Occurrence of Clinical pregnancy after IUI
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20160703028756N5
Registration date:2018-12-23, 1397/10/02
Registration timing:prospective
Last update:2018-12-23, 1397/10/02
Update count:0
Registration date
2018-12-23, 1397/10/02
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
2019-01-05, 1397/10/15
Expected recruitment end date
2019-06-05, 1398/03/15
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Evaluation of efficiency and side effects of intrauterine insemination (IUI) catheter, a product of Slamtyar Hakim Engineering company, in infertile couples
Public title
Evaluation of efficiency and side effects of intrauterine insemination (IUI) catheter in infertile couples
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Having 2 to 3 follicles of the right size,
Tubes open
Acceptable Sperm Test for IUI
Exclusion criteria:
Women older than 42 years
Double-sided tubular obstruction
Couples with sperm concentration less than 10 million spermatozoa per ml
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
In this study, a continuous sampling method based on the criteria for entering and leaving the study is used. The method of assigning samples to the groups is a randomized block design with two blocks of four blocks. The letter A for the masstec catheter and the letter B for the PM IU catheter group are considered. Then write all the permutation combinations of the letters A, A, B, and B, which are six different combinations (AABB for digit 1, ABBA for digit 2 ...), then we select a digit from the digits 1 to 6. For example, if digit 2 is selected, its concept is that the first person in the intervention group is the next two in the control group and the fourth in the intervention group. Continue this until the sample size reaches to 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
خیابان هزار جریب
City
اصفهان
Province
Isfehan
Postal code
81746-73461
Approval date
2018-10-29, 1397/08/07
Ethics committee reference number
IR.MUI.MED.REC.1397.115
Health conditions studied
1
Description of health condition studied
Infertility
ICD-10 code
N97
ICD-10 code description
Female infertility
Primary outcomes
1
Description
Problem with catheter insertion
Timepoint
At the time of IUI
Method of measurement
Questionnaire
2
Description
Need to Tenaculum
Timepoint
At the time of IUI
Method of measurement
Questionnaire
3
Description
Need for cervical dilatation
Timepoint
At the time of IUI
Method of measurement
Questionnaire
Secondary outcomes
1
Description
Chemical pregnancy rate
Timepoint
2 weeks after IUI
Method of measurement
HCG Test
2
Description
Clinical pregnancy rate
Timepoint
5 weeks after IUI
Method of measurement
Sonography
Intervention groups
1
Description
In the control group, intrauterine insemination of the sperm will be performed by a catheter from France.
Category
Treatment - Devices
2
Description
Intervention group: In the intervention group, IUI is performed by the IUI catheter ® masstec (Salamat Yar Hakim, Iran).