Investigating the relationship between midcycle progesterone level and success rate in IuI(Intrauterine sperm injection) cycles
Design
The study will be conducted on 200 women aged 18 to 35 with primary or secondary infertility who are candidates for IUI (Intrauterine sperm injection) Patients will be do not randomized
Settings and conduct
This study will be carried out at al-Zahra hospital in Tabriz. 200 women aged 18 to 35 with primary or secondary infertility who are candidates for IUI(Intrauterine sperm injection) will be included in the study.From the third day of the cycle, two tablets of clomfenin or letrozole are given daily for 5 days, and on days 6, 8 and 10, one gonadotropin is given and vaginal sonography is given 5 days after the end of the pill. If there is at least one dominant follicle Above 18 mm) HCG(Human gonadotropin hormone) and measured the serum LH(Luteinizing Hormone) and progesterone levels the same day before administration of HCG. 36 hours after HCG injection, IuI is performed and 14 days after IuI pregnancy test is performed and HCG blood is measured. If HCG is positive, 2 weeks later ultrasound is performed from pregnant patients. Pregnancy rates are compared at different levels of serum progesterone.
Participants/Inclusion and exclusion criteria
Infertile women aged 18 to 35 years and in case of hyperprolactinemia, thyroid disorders, endometriosis, and severe male factor do not enter the study.
Intervention groups
From the third day of the cycle, two tablets of clomfenin or letrozole are given daily for 5 days, and on days 6, 8 and 10, one gonadotropin is given and vaginal sonography is given 5 days after the end of the pill. If there is at least one dominant follicle Above 18 mm) HCG(Human gonadotropin hormone) and measured the serum LH(Luteinizing Hormone) and progesterone levels the same day before administration of HCG. 36 hours after HCG injection, IuI is performed and 14 days after IuI pregnancy test is performed and HCG blood is measured. If HCG is positive, 2 weeks later ultrasound is performed from pregnant patients. Pregnancy rates are compared at different levels of serum progesterone.
Main outcome variables
Progesterone level
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20110301005942N5
Registration date:2018-01-17, 1396/10/27
Registration timing:prospective
Last update:2018-01-17, 1396/10/27
Update count:0
Registration date
2018-01-17, 1396/10/27
Registrant information
Name
Aliye Ghasemzadeh
Name of organization / entity
Tabriz University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 41 3553 9160
Email address
gasemzadeha@tbzmed.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2018-01-20, 1396/10/30
Expected recruitment end date
2019-02-19, 1397/11/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Investigating the relationship between mid-cycle progesterone level and success rate in IuI(Intrauterine sperm injection) cycles
Public title
Investigating the relationship between mid-cycle progesterone level and success rate in IuI(Intrauterine sperm injection) cycles.
Purpose
Diagnostic
Inclusion/Exclusion criteria
Inclusion criteria:
Women with primary or secondary infertility
Age between 18 and 35 years
Exclusion criteria:
Hyperprolactinemia
Thyroid disorders
Endometriosis
sever mail factor
Age
From 18 years old to 35 years old
Gender
Female
Phase
2
Groups that have been masked
No information
Sample size
Target sample size:
200
Randomization (investigator's opinion)
N/A
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Single
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee Of Tabriz University Of Medical Sciences
Street address
Third Floor, Central Building of Number2, Golgasht Street
City
Tabriz
Province
East Azarbaijan
Postal code
5138665793
Approval date
2017-11-16, 1396/08/25
Ethics committee reference number
IR.TBZMED.REC.1395.701
Health conditions studied
1
Description of health condition studied
Female Infertility
ICD-10 code
N97
ICD-10 code description
Female infertility
Primary outcomes
1
Description
Reducing the cost of infertility treatment with regard to the ability to determine the success rate in that cycle
Timepoint
14 days after IuI
Method of measurement
Blood HCG test
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group:From the third day of the cycle, two tablets of clomfenin or letrozole are given daily for 5 days, and on days 6, 8 and 10, one gonadotropin is given and vaginal sonography is given 5 days after the end of the pill. If there is at least one dominant follicle Above 18 mm) HCG(Human gonadotropin hormone) and measured the serum LH(Luteinizing Hormone) and progesterone levels the same day before administration of HCG. 36 hours after HCG injection, IuI(Intrauterine sperm injection) is performed and 14 days after IuI pregnancy test is performed and HCG blood is measured. If HCG is positive, 2 weeks later ultrasound is performed from pregnant patients. Pregnancy rates are compared at different levels of serum progesterone performed from pregnant patients. Pregnancy rates are compared at different levels of serum progesterone.
Category
Diagnosis
Recruitment centers
1
Recruitment center
Name of recruitment center
Alzahra Hospital
Full name of responsible person
Aliyeh Ghasemzadeh
Street address
Alzahra Hospital, South Artesh St.
City
Tabriz
Province
East Azarbaijan
Postal code
5138665793
Phone
+98 41 3553 9161
Email
lahroudin@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice chancellor for Research,Tabriz University Of Medical Sciences
Full name of responsible person
Dr.Alireza Rashidi
Street address
Third Floor, Central Building of Number2, Golgasht Street
City
Tabriz
Province
East Azarbaijan
Postal code
5138665793
Phone
+98 41 3553 9161
Email
lahroudin@gmail.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Vice chancellor for Research,Tabriz 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
Tabriz University of Medical Sciences
Full name of responsible person
Aliyeh Ghasemzadeh
Position
Professor of Obstetrics and Gynecology
Latest degree
Subspecialist
Other areas of specialty/work
Gynecology and Obstetrics
Street address
Tabriz University Of Medical Sciences, Golgasht Street
City
Tabriz
Province
East Azarbaijan
Postal code
5138665793
Phone
+98 41 3553 9161
Email
lahroudin@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Aliyeh Ghasemzadeh
Position
Professor of Obstetrics and Gynecologyاستاد زنان مامایی آخرین مدرک تحصیلیفوق تخصص
Latest degree
Subspecialist
Other areas of specialty/work
Gynecology and Obstetrics
Street address
Tabriz University Of Medical Sciences, Golgasht Street
City
Tabriz
Province
East Azarbaijan
Postal code
5138665793
Phone
+98 41 3553 9161
Email
lahroudin@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Aliyeh Ghasemzadeh
Position
Professor of Obstetrics and Gynecology
Latest degree
Subspecialist
Other areas of specialty/work
Gynecology and Obstetrics
Street address
Tabriz University Of Medical Sciences, Golgasht Street
City
Tabriz
Province
East Azarbaijan
Postal code
5138665793
Phone
+98 41 3553 9161
Email
lahroudin@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
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