Comparison of the pregnancy rate following Intra Uterine Insemination 36 and 42 hours after human chorionic gonadotropin injection in infertile women
Design
Phase 2-3 randomized clinical trial with parallel groups which will be conducted on 70 infertile women.
Settings and conduct
Using block randomization method with blocks of ten, the patients referred to Ali Ebne Abi Taleb hospital in Zahedan,w ill be assigned into two groups of Intra Uterine Insemination 36 and 42 hours after human chorionic gonadotropin injection.
Participants/Inclusion and exclusion criteria
Inclusion criteria: Normal spermiogram; Body mass index of 18-30; Unexplained infertility
Exclusion criteria: Bilateral tubal obstruction; Severe endometriosis; Uterine anomaly; Endocrine disorders such as Diabetes or thyroid gland disorders
Intervention groups
Intervention group 1: Injection of 0.5 cc sperm 36 hours after human chorionic gonadotropin
Intervention group 2: Injection of 0.5 cc sperm 42 hours after human chorionic gonadotropin
Main outcome variables
Pregnancy rate
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20180428039442N1
Registration date:2018-05-12, 1397/02/22
Registration timing:prospective
Last update:2018-05-12, 1397/02/22
Update count:0
Registration date
2018-05-12, 1397/02/22
Registrant information
Name
Mahbube Firooz
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 54 3329 5715
Email address
dr.m.sirous@zaums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2018-05-22, 1397/03/01
Expected recruitment end date
2018-07-23, 1397/05/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of the pregnancy rate following Intra Uterine Insemination 36 and 42 hours after human chorionic gonadotropin injection in infertile women
Public title
The effect of Intra Uterine Insemination time on pregnancy rate
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Normal spermiogram
Body mass index of 18-30
Unexplained infertility
Normal oovulation
Exclusion criteria:
Bilateral tubal obstruction
Severe endometriosis
Uterine anomaly
Endocrine disorders such as Diabetes or thyroid gland disorders
Age
From 18 years old to 35 years old
Gender
Female
Phase
2-3
Groups that have been masked
No information
Sample size
Target sample size:
70
Randomization (investigator's opinion)
Randomized
Randomization description
block randomization with blocks of ten
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 Zahedan University of Medical Sciences
Street address
Zahedan University of Medical Sciences and Health Services campus, Khalije Fars Blv, Doctor Hesabi Sq, Zahedan
City
Zahedan
Province
Sistan-va-Balouchestan
Postal code
9916789547
Approval date
2018-01-14, 1396/10/24
Ethics committee reference number
IR.ZAUMS.REC.1396.347
Health conditions studied
1
Description of health condition studied
Infertility
ICD-10 code
N97.9
ICD-10 code description
Female infertility, unspecified
Primary outcomes
1
Description
Pregnancy rate
Timepoint
16 days after human chorionic gonadotropin injection
Method of measurement
By measuring beta-human chorionic gonadotropin (B-hCG)
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group 1: Injection of 0.5 cc sperm 36 hours after human chorionic gonadotropin
Category
Treatment - Other
2
Description
Intervention group 2: Injection of 0.5 cc sperm 42 hours after human chorionic gonadotropin
Category
Treatment - Other
Recruitment centers
1
Recruitment center
Name of recruitment center
Ali Ebne Abi Taleb Hospital
Full name of responsible person
Mahbube Firooz
Street address
Khalije Fars Blv, Zahedan
City
Zahedan
Province
Sistan-va-Balouchestan
Postal code
9916789547
Phone
+98 54 3329 5715
Email
dr.m.sirous@zaums.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Zahedan University of Medical Sciences
Full name of responsible person
Mohsen Taheri
Street address
Vice chancellor for research, Zahedan University of Medical Sciences, Zahedan
City
Zahedan
Province
Sistan-va-Balouchestan
Postal code
9816743463
Phone
+98 54 3329 5721
Email
Dr.Taheri@zaums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Zahedan 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
Zahedan University of Medical Sciences
Full name of responsible person
Mahbube Firooz
Position
Gynecology and Obstetrics Resident
Latest degree
Medical doctor
Other areas of specialty/work
Gynecology and Obstetrics
Street address
Zahedan University of Medical Sciences and Health Services campus, Khalije Fars Blv, Doctor Hesabi Sq, Zahedan
City
Zahedan
Province
Sistan-va-Balouchestan
Postal code
9916789547
Phone
+98 54 3329 5715
Email
dr.m.sirous@zaums.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Zahedan University of Medical Sciences
Full name of responsible person
Mahbube Firooz
Position
Gynecology and Obstetrics Resident
Latest degree
Medical doctor
Other areas of specialty/work
Gynecology and Obstetrics
Street address
Zahedan University of Medical Sciences and Health Services campus, Khalije Fars Blv, Doctor Hesabi Sq, Zahedan
City
Zahedan
Province
Sistan-va-Balouchestan
Postal code
9916789547
Phone
+98 54 3329 5715
Email
dr.m.sirous@zaums.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Zahedan University of Medical Sciences
Full name of responsible person
Mahbube Firooz
Position
Gynecology and Obstetrics Resident
Latest degree
Medical doctor
Other areas of specialty/work
Gynecology and Obstetrics
Street address
Zahedan University of Medical Sciences and Health Services campus, Khalije Fars Blv, Doctor Hesabi Sq, Zahedan
City
Zahedan
Province
Sistan-va-Balouchestan
Postal code
9916789547
Phone
+98 54 3329 5715
Email
dr.m.sirous@zaums.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