Comparison of the effect of trigger ovulation HCG and HCG + Oxytocin on Creating the Pregnancy
Design
Phase 2-3 randomized clinical trial with parallel groups which will be conducted on 50 infertile women
Settings and conduct
This study will be conducted with the aim of comparison the effect of HCG plus oxytocin and HCG alone on pregnancy rate in 50 infertile women. After inclusion in the study, using block randomization method with blocks of ten, the patients will be assigned into two groups; intervention group 1 receiving 5000 units HCG with 5 mg oxytocin intramuscularly and intervention group 2 receiving 5000 units HCG intramuscularly. 14 days after giving the drugs, the pregnancy will be evaluated by measuring the serum level of B-HCG and will be compared together.
Participants/Inclusion and exclusion criteria
Inclusion criteria: infertility more than 1 year; having normal uterine cavity and at least one normal fallopian tube
Exclusion criterion: Infertility due to male factors
Intervention groups
Intervention group 1: receiving 5000 units HCG with 5 mg oxytocin intramuscularly
Intervention group 2: receiving 5000 units HCG intramuscularly
Main outcome variables
Pregnancy
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20180307038987N1
Registration date:2018-11-01, 1397/08/10
Registration timing:registered_while_recruiting
Last update:2018-11-01, 1397/08/10
Update count:0
Registration date
2018-11-01, 1397/08/10
Registrant information
Name
Shahnaz Nezamdoust
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 54 3329 5633
Email address
sh.135656.nez@zaums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2018-09-06, 1397/06/15
Expected recruitment end date
2018-11-06, 1397/08/15
Actual recruitment start date
2018-09-23, 1397/07/01
Actual recruitment end date
2018-12-22, 1397/10/01
Trial completion date
2019-01-21, 1397/11/01
Scientific title
Comparison of the effect of trigger ovulation HCG and HCG + oxytocin on creating the pregnancy
Public title
The effect of HCG and HCG plus oxytocin on pregnancy rate
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Infertility more than 1 year
Having normal uterine cavity and at least one normal fallopian tube
Exclusion criteria:
Infertility due to male factors
Age
From 18 years old to 40 years old
Gender
Female
Phase
2-3
Groups that have been masked
No information
Sample size
Target sample size:
50
Actual sample size reached:
50
More than 1 sample in each individual
Actual sample size in each individual:
1
Blood Sample
Randomization (investigator's opinion)
Randomized
Randomization description
Block randomization with blocks of 10.
The patients will be randomly assigned into 2 groups of 25. Considering the sample size of 50 ( 25 patients in HCG group and 25 patients in HCG plus oxytocin group) , 5 blocks with 10 people will be selected; in each block there will be 5 cards of HCG group and 5 cards of HCG plus oxytocin group. So by selecting each block, 5 people will be assigned into each group.
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
9816743463
Approval date
2018-09-23, 1397/07/01
Ethics committee reference number
IR.ZAUMS.REC.1397.256
Health conditions studied
1
Description of health condition studied
Infertility
ICD-10 code
N97
ICD-10 code description
Female infertility
Primary outcomes
1
Description
Pregnancy
Timepoint
14 days after giving the study drugs
Method of measurement
By measuring B-HCG serum level
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group 1: receiving 5000 units HCG with 5 mg oxytocin intramuscularly
Category
Treatment - Drugs
2
Description
Intervention group 2: receiving 5000 units HCG intramuscularly
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Ali Ebne Abi Taleb Hospital
Full name of responsible person
Shahnaz Nezamdoost
Street address
Khalije Fars Blv, Zahedan
City
Zahedan
Province
Sistan-va-Balouchestan
Postal code
9816743111
Phone
+98 54 3329 5577
Email
sh.135656.nez@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
9816743111
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
Shahnaz Nezamdoost
Position
Gynecology 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
9816743111
Phone
+98 54 3329 5575
Email
sh.135656.nez@zaums.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Zahedan University of Medical Sciences
Full name of responsible person
Shahnaz Nezamdoost
Position
Gynecology 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
9816743111
Phone
+98 54 3329 5575
Email
sh.135656.nez@zaums.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Zahedan University of Medical Sciences
Full name of responsible person
Shahnaz Nezamdoost
Position
Gynecology 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
9816743111
Phone
+98 54 3329 5575
Email
sh.135656.nez@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
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
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