Evaluation of the effect of uterine flushing with human chorionic gonadotropin (hCG) on biochemical and clinical pregnancy rate in the IUI cycle of couples with idiopathic infertility
Evaluation of the effect of uterine flushing with human chorionic gonadotropin (hCG) on biochemical and clinical pregnancy rate in the IUI cycle of couples with idiopathic infertility
Design
The present study will be a randomized controlled trial.The method of sampling from the population will be Simple random sampling and couples with the diagnosis of unexplained infertility will be included in the study. There are 80 couples with unexplained infertility divided to intervention and control groups(40 patients in each group) and the age of all members is between 20-38 years.
Settings and conduct
This study will be conducted in the field of infertility treatment on 80 patients referred to the infertility clinic of Alzahra Hospital in Tabriz.
Patients will be randomly divided into two groups of 40 people. The control group will receive 10,000 units of hCG intramuscularly.
And the intervention group, in addition to intramuscular injection, two hours before intrauterine sperm insemination (IUI), 1000 units of hCG will be diluted in half a cc of normal saline and injected directly into the uterine cavity.
Participants/Inclusion and exclusion criteria
In this study, women diagnosed with primary or secondary infertility between the ages of 20 and 38 will be included in the study if they have consent, and if they have blocked fallopian tubes or any hormonal disorder, they will be prohibited from entering the study.
Intervention groups
we inject 10000 IU intra muscular hCG in both groups. 34-36 hours later the IUI will be performed as usual. 2 hours before the IUI, In intervention group we Dilute 1000 IU hCG in 0.5 cc of normal saline and inject directly in the uterus cavity but in control group we just inject 0.5 cc of normal saline into the uterus.
Main outcome variables
Clinical pregnancy is considered as the main outcome of this study.
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20220702055335N1
Registration date:2022-08-09, 1401/05/18
Registration timing:registered_while_recruiting
Last update:2022-08-09, 1401/05/18
Update count:0
Registration date
2022-08-09, 1401/05/18
Registrant information
Name
Parvin Hakimi
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 41 3553 9161
Email address
parvin.hakimi56@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2022-08-06, 1401/05/15
Expected recruitment end date
2023-08-06, 1402/05/15
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Evaluation of the effect of uterine flushing with human chorionic gonadotropin (hCG) on biochemical and clinical pregnancy rate in the IUI cycle of couples with idiopathic infertility
Public title
Evaluation of the effect of uterine flushing with human chorionic gonadotropin (hCG) on biochemical and clinical pregnancy rate in the IUI cycle of couples with idiopathic infertility
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Having an informed consent to participate in the study
Unexplained infertility diagnosis
The health of the uterus structure
Normal sperm analysis
Women between 20 and 38 years old
The presence of ovulation
Exclusion criteria:
unsatisfaction for the participation of study
Moderate to severe endometriosis
hyper prolactinemia
Hyperthyroidism
Hypothyroidism
Ovarian Cysts
Kidney and liver failure
Blocked fallopian tubes
Increased FSH
Age
From 20 years old to 38 years old
Gender
Female
Phase
3
Groups that have been masked
Outcome assessor
Data analyser
Sample size
Target sample size:
80
Randomization (investigator's opinion)
Randomized
Randomization description
Patients who meet the inclusion criteria are divided into two intervention groups using simple randomization method.The randomization method used in this study is the use of a table of random numbers.Random number table is a set of numbers that is generated without a specific pattern or order and they generated randomly and they are formed in a table.In first the direction of reading the numbers was specified.To read the numbers, random numbers are read from the left side of the table, then even numbers extracted from the table are allocated to intervention group 1 and odd numbers extracted from the table are allocated to intervention group 2.
Blinding (investigator's opinion)
Double blinded
Blinding description
Before prescribing the drug to the patient, the plan is introduced and written consent is received. Study at the patient level, outcome assessor and statistical analyzer of the results will be blinded.
Placebo
Not used
Assignment
Parallel
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
5166616471
Approval date
2022-06-01, 1401/03/11
Ethics committee reference number
IR.TBZMED.REC.1401.233
Health conditions studied
1
Description of health condition studied
Female infertility
ICD-10 code
N97.9
ICD-10 code description
Female infertility, unspecified
Primary outcomes
1
Description
clinical pregnancy rate
Timepoint
28 days after transfer
Method of measurement
vaginal sonography
2
Description
chemical pregnancy rate
Timepoint
14 days after transfer
Method of measurement
BhCG test
Secondary outcomes
empty
Intervention groups
1
Description
Control group: At the beginning of menstruation and on the third day, an ultrasound will be performed, and from the third day of menstruation, 1 or 2 tablets of letrozole 2.5 mg will be prescribed daily for 5 days. Then, according to the age and state of ovarian reserve, We may inject Cinnal-F ampoule (Cina Gene Pharmaceuticals) 75 units subcutaneously on days 6, 8 and 10. Then on the 10th or 11th day, an ultrasound will be performed and if one or two follicles with a size larger than 18-20 mm and endometrial thickness greater than 7 mm are observed, 10,000 units of hCG will be injected intramuscularly.34-36 hours later the IUI will be performed as usual. In this group, two hours before IUI, 0.5 cc of normal saline will be injected into the uterus as a placebo.
Category
Treatment - Drugs
2
Description
intervention group: At the beginning of menstruation and on the third day, an ultrasound will be performed, and from the third day of menstruation, 1 or 2 tablets of letrozole 2.5 mg will be prescribed daily for 5 days. Then, according to the age and state of ovarian reserve, We may inject Cinnal-F ampoule (Cina Gene Pharmaceuticals) 75 units subcutaneously on days 6, 8 and 10. Then on the 10th or 11th day, an ultrasound will be performed and if one or two follicles with a size larger than 18-20 mm and endometrial thickness greater than 7 mm are observed, 10,000 units of hCG will be injected intramuscularly.34-36 hours later the IUI will be performed as usual. In this group, two hours before IUI,1000 IU hCG will be diluted in 0.5 cc of normal saline and will be injected directly in the uterus cavity.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Alzahra Hospital
Full name of responsible person
Dr.Parvin Hakimi
Street address
Alzahra Hospital, South Artesh St.,Tabriz, iran
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
Full name of responsible person
Dr.Parviz Shahabi
Street address
No. 2 Central Building,Tabriz University of Medical Sciences, Golgasht Street, Tabriz
City
Tabriz
Province
East Azarbaijan
Postal code
5138665793
Phone
+98 41 3335 7310
Email
research-vice@tbzmed.ac.ir
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
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
Parvin Hakimi
Position
Associate Professor of Obstetrics 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 35519161
Email
lahroudin@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Parvin Hakimi
Position
Associate Professor of Obstetrics 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 35519161
Email
lahroudin@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Parvin Hakimi
Position
Associate Professor of Obstetrics 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 35519161
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