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Comparing the effect of late versus early removal of IUI catheter on the pregnancy outcomes.

Protocol summary

Study aim
Determining the effect of late withdrawal of IUI catheter on the clinical pregnancy rate
Design
This clinical trial with a control group, with parallel groups, randomized, phase 1-2 will be conducted on 30 women candidates for intrauterine insemination (IUI). The method of random allocation of permutation blocks is done using Random Allocation software. Blinding is not done in this study.
Settings and conduct
The researcher will select 30 women candidates for IUI referring to Faqihi Hospital in Shiraz by the available method and will randomly divide the replacement blocks into two groups A and B. For group A (intervention), during the IUI procedure, the catheter remains in the uterus for 10 minutes and then it is removed, and for group B (control), the catheter is removed immediately after IUI. Both groups rest supine on the bed for 10 minutes after the procedure. Then, during the next 2 weeks, bHCG examination, biochemical pregnancy and 6 weeks later, clinical pregnancy ultrasound will be determined. The pregnancy rate is checked by a gynecologist.
Participants/Inclusion and exclusion criteria
inclusion criteria : 1- 18-35 years old, 2- Hystrosalpingography is normal 3-normal hormonal tests including FSH, LH, TSH and Prolactin4- Consent to participate in the study exclusion criteria:chronic diseases such as diabetes with thyroid disorders
Intervention groups
Group A (intervention) during the IUI procedure, the catheter remains in the uterus for 10 minutes and then it is removed, and for group B (control), the catheter is removed immediately after IUI.
Main outcome variables
The outcome to be investigated is the pregnancy rate, which is determined 2 weeks after the IUI procedure by examining bHCG, biochemical pregnancy, and 6 weeks later by ultrasound, the clinical pregnancy rate is determined.

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20240610062070N1
Registration date: 2024-07-04, 1403/04/14
Registration timing: retrospective

Last update: 2024-07-04, 1403/04/14
Update count: 0
Registration date
2024-07-04, 1403/04/14
Registrant information
Name
Parya Nekoeian
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 71 3230 5410
Email address
parya.nek.1993@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2024-04-03, 1403/01/15
Expected recruitment end date
2024-06-19, 1403/03/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparing the effect of late versus early removal of IUI catheter on the pregnancy outcomes.
Public title
Comparison of late withdrawal of IUI catheter with early withdrawal during IUI procedure on pregnancy rate and pregnancy outcomes
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Age between 18 and 45 years Hysterosalpingography is normal Normal hormonal tests include FSH, LH, TSH, Prolactin Consent to participate in the study
Exclusion criteria:
Suffering from chronic diseases such as diabetes or thyroid disorders
Age
From 18 years old to 35 years old
Gender
Female
Phase
1-2
Groups that have been masked
No information
Sample size
Target sample size: 30
Randomization (investigator's opinion)
Randomized
Randomization description
The method of random allocation of replacement blocks will be done using Random Allocation software. In this way, first, various quadruple blocks are created (ABBA, BABA, ABAB, BBAA, AABB, and BABA) and one of these blocks is randomly selected, and according to the order mentioned in the selected block, the patients are divided into one of two groups, A or B. be. Then randomization will be done for other patients as well. For group A (late catheter withdrawal), the catheter remains in the uterus for 10 minutes during the IUI procedure and then it is removed, and for group B (premature catheter withdrawal), the catheter is removed immediately after IUI.
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 Shiraz University of Medical Sciences
Street address
Zand Street, in front of Palestine Street, central building of Shiraz University of Medical Sciences
City
shiraz
Province
Fars
Postal code
7134814336
Approval date
2024-03-11, 1402/12/21
Ethics committee reference number
IR.SUMS.MED.REC.1402.565

Health conditions studied

1

Description of health condition studied
Pregnancy
ICD-10 code
O00-O99
ICD-10 code description
Trimesters are counted from the first day of the last menstrual period. They are defined as follows:1st trimester- less than 14 weeks 0 days2nd trimester- 14 weeks 0 days to less than 28 weeks 0 days3rd trimester- 28 weeks 0 days until delivery

Primary outcomes

1

Description
Clinical pregnancy rate
Timepoint
6 weeks after the intervention
Method of measurement
یافته های سونوگرافی

Secondary outcomes

empty

Intervention groups

1

Description
For women undergoing intrauterine insemination, the catheter remains in the uterus for 10 minutes and then it is removed (catheter late withdrawal group).
Category
Treatment - Devices

2

Description
Control group: For women who undergo intrauterine insemination treatment, it will be removed from the uterus immediately after IUI (catheter early exit group).
Category
Treatment - Devices

Recruitment centers

1

Recruitment center
Name of recruitment center
Shahid Faqihi Hospital in Shiraz
Full name of responsible person
Priya Nekoeian
Street address
Karim Khan Zand Boulevard - next to the medical school
City
shiraz
Province
Fars
Postal code
7134846114
Phone
+98 71 3235 1087
Email
FaghihiHsp@Sums.ac.ir

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Shiraz University of Medical Sciences
Full name of responsible person
Dr. Mohammad Hashem Hashempour
Street address
Zand Street, in front of Palestine Street, central building of Shiraz University of Medical Sciences
City
shiraz
Province
Fars
Postal code
7134814336
Phone
+98 71 3235 7282
Email
hashempurm@sums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Shiraz 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
Shiraz University of Medical Sciences
Full name of responsible person
parya nekooeian
Position
Obstetrics and Gynecology Resident
Latest degree
Medical doctor
Other areas of specialty/work
Gynecology and Obstetrics
Street address
Zand Street, in front of Palestine Street, central building of Shiraz University of Medical Sciences
City
shiraz
Province
Fars
Postal code
7134814336
Phone
+98 71 3230 5410
Email
paryanekooeian@gmail.com

Person responsible for scientific inquiries

Contact
Name of organization / entity
Shiraz University of Medical Sciences
Full name of responsible person
parya nekooeian
Position
Obstetrics and Gynecology Resident
Latest degree
Medical doctor
Other areas of specialty/work
Gynecology and Obstetrics
Street address
Zand Street, in front of Palestine Street, central building of Shiraz University of Medical Sciences
City
shiraz
Province
Fars
Postal code
7134814336
Phone
+98 71 3230 5410
Email
paryanekooeian@gmail.com

Person responsible for updating data

Contact
Name of organization / entity
Shiraz University of Medical Sciences
Full name of responsible person
parya nekooeian
Position
Obstetrics and Gynecology Resident
Latest degree
Medical doctor
Other areas of specialty/work
Gynecology and Obstetrics
Street address
Zand Street, in front of Palestine Street, central building of Shiraz University of Medical Sciences
City
shiraz
Province
Fars
Postal code
7134814336
Phone
+98 71 3230 5410
Email
paryanekooeian@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
No - There is not a plan to make this available
Informed Consent Form
No - There is not a plan to make this available
Clinical Study Report
No - There is not 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
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