Comparison between the success of clinical pregnancy in patients undergoing IUI with different volumes of air inside the catheter insemination performed during intrauterine insemination of sperm
Design
The controlled, parallel group, double blinded, randomized, phase II, on 3 groups consisted 90 patients and single center clinical trial. The randomization is performed using rand function. Two groups are considered as intervention and one group is considered as control. Patients were followed until two months after intervention.
Settings and conduct
The study will be performed at Imam Khomeini Hospital. Study will be Double blind, both the patient and the evaluator of the results will be unaware of the intervention.
Hysterosalpingography is performed for all patients in all three groups for women and semen for men. All IUI cycles will be stimulated by ovarian gonadotropic stimulation from the second day of menstruation until the day of ovulation.
At the stage of IUI, patients are divided into three groups according to the volume of air in the sperm injection catheter: volume of half a ml, 1 ml and no air.
A soft catheter will be placed in the middle of the uterine cavity and a volume of semen will be injected in 15 seconds. After this time, perform pregnancy diagnostic tests (serum level b-hCG is recommended. And clinical pregnancy is performed according to ultrasound criteria to detect fetal heart rate 12 weeks later.
Participants/Inclusion and exclusion criteria
Inclusion criteria: Women with open fallopian tubes, FSH levels less than 12 IU/L, and normal sperms.
Exclusion criteria: IUIs with donor sperm were excluded from the present study.
Intervention groups
At the stage of IUI, patients are divided into three groups according to the volume of air in the sperm injection catheter: volume of half a ml, 1 ml and no air.
Main outcome variables
Pregnancy rate
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20201110049331N1
Registration date:2020-12-13, 1399/09/23
Registration timing:registered_while_recruiting
Last update:2020-12-13, 1399/09/23
Update count:0
Registration date
2020-12-13, 1399/09/23
Registrant information
Name
Roshan Nikbakht
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 61 3221 6104
Email address
nikbakht-r@ajums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2019-12-22, 1398/10/01
Expected recruitment end date
2020-12-21, 1399/10/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The efficacy and safety of intrauterine insemination (IUI) with different volumes of air during insemination catheter in infertile couples
Public title
َThe air volume in intrauterine insemination
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Women with open fallopian tubes
FSH levels less than 12 IU/L
Normal sperms
Exclusion criteria:
IUIs with donor sperm were excluded from the present study
Age
From 20 years old to 45 years old
Gender
Female
Phase
3
Groups that have been masked
Participant
Investigator
Sample size
Target sample size:
270
Randomization (investigator's opinion)
Randomized
Randomization description
The simple and individual randomization using random numbers were used. The random number are presented in sealed envelopes.
Blinding (investigator's opinion)
Double blinded
Blinding description
The participants and evaluators were blinded from the type of intervention.
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics comittee of Ahvaz Jundishapur University of Medical Sciences
Street address
Golestan Blvd., Ahvaz Jundishapur University of Medical Sciences, Central Building
City
Ahvaz
Province
Khouzestan
Postal code
6135715794
Approval date
2018-10-06, 1397/07/14
Ethics committee reference number
IR.AJUMS.REC.1397.464
Health conditions studied
1
Description of health condition studied
Infertility
ICD-10 code
N97
ICD-10 code description
Female infertility
Primary outcomes
1
Description
Fertility rate
Timepoint
2 months after intervention
Method of measurement
Clinical pregnancy using sonography
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group 1: The volume of air in the catheter when injecting sperm in the first intervention group is 0.5 ml.
Category
Treatment - Devices
2
Description
Intervention group: The volume of air in the catheter when injecting sperm in the second intervention group is 1 ml
Category
Treatment - Devices
3
Description
Control group: The volume of air in the catheter when injecting sperm in the control group is zero.
Category
Other
Recruitment centers
1
Recruitment center
Name of recruitment center
Imam Khomeini Hospital
Full name of responsible person
Roshan Nikbakht
Street address
Azadegan Avn., Imam Khomeini Hospital
City
Ahvaz
Province
Khouzestan
Postal code
6193673166
Phone
+98 61 3221 6504
Email
nikbakht-r@ajums.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Ahvaz University of Medical Sciences
Full name of responsible person
Mehdi Ahmadi Mghadam
Street address
Golestan Blv.
City
Ahvaz
Province
Khouzestan
Postal code
6135715794
Phone
+98 61 3373 8383
Email
ahmadi-m@ajums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
No
Title of funding source
Vice chancellor for research of Ahvaz Jundishapur 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
Ahvaz University of Medical Sciences
Full name of responsible person
Roshan Nikbakht
Position
Associate Professor
Latest degree
Subspecialist
Other areas of specialty/work
Gynecology and Obstetrics
Street address
Imam Khomeini Hospital, Azadegan Street
City
Ahvaz
Province
Khouzestan
Postal code
6135715794
Phone
+98 61 3221 6104
Fax
Email
nikbakht-r@ajums.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Ahvaz University of Medical Sciences
Full name of responsible person
Roshan Nikbakht
Position
Associate Professor
Latest degree
Subspecialist
Other areas of specialty/work
Gynecology and Obstetrics
Street address
Imam Khomeini Hospital, Azadegan Street
City
Ahvaz
Province
Khouzestan
Postal code
6135715794
Phone
+98 61 3221 6104
Fax
Email
nikbakht-r@ajums.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Ahvaz University of Medical Sciences
Full name of responsible person
Roshan Nikbakht
Position
Associate Professor
Latest degree
Subspecialist
Other areas of specialty/work
Gynecology and Obstetrics
Street address
Imam Khomeini Hospital, Azadegan Street
City
Ahvaz
Province
Khouzestan
Postal code
6135715794
Phone
+98 61 3221 6104
Fax
Email
nikbakht-r@ajums.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
Not applicable
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