The study population will be selected from patients with non – fertilized in 25-30 years old with normal ovarian reserve tests and normal hysterosalpingography. The study population includes 160 women with PCO, unexplained infertility and mild Endometriosis. Patients will randomly divided into 2 groups A and B In one Group (Controls Group) will do routine method of IVF and in second group will do IUI with injecting HCG simultaneous when the patients refer to visit and doing vaginal sonography on days 1-5 of menstrual cycle if the sonography is a normal ovulation will start with administration of clomiphene and HCG. Again patients will be controlled on days 11-13 of menstrual cycle with vaginal sonography and if Maximum 3 dominant follicles will be seen in both ovaries, cycle will be continued. Patients in control group (A group) , one dose of HCG (5000 units) will be injected at 8-9 pm on the same day and after 36-40 hours IUI will be done. Patient in B group will be done IUI in the same day and after 20 minutes single dose of HCG (5000 units) will be injected. For supporting (luteal) phase in both groups progesterone vaginal suppositories will be administrated about 16 days and at 17th day pregnancy test will be done and if it is positive using sup positives will continue. Both groups will be equally the same about courses of infertility and dominant follicles. Pregnancy rates are considered as the primary out come.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2013060313566N1
Registration date:2013-07-14, 1392/04/23
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2013-07-14, 1392/04/23
Registrant information
Name
Kobra Hamdi
Name of organization / entity
Tabriz University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 41 1554 1221
Email address
hamdik@tbzmed.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice chancellor for research,Tabriz University of Medical Scienes
Expected recruitment start date
2013-07-11, 1392/04/20
Expected recruitment end date
2014-10-12, 1393/07/20
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of pregnancy rate in standard IUI with administration of HCG
simultaneity with IUI
Public title
Comparison of pregnancy rate in standard IUI with administration of HCG
simultaneity with IUI
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: women with non-fertilized in 25-30 years old with normal ovarian reserves tests and normal. (Hystro Salpangografy); women with mild male factor and reduced ovulation among patients with pco, unexplained infertility and mild endometrioses and the desire to participate in the study.
Exclusion criteria: server endometriosis; anomalies such as two uterine horns or cache; case will be dismissed IUI treatment such as obstruction of tabular uterus in parameters of liquid semen.
Age
From 20 years old to 35 years old
Gender
Female
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
160
Randomization (investigator's opinion)
Randomized
Randomization description
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 Tabriz University of Medical Sciences
Street address
Tabriz university of medical sciences, Golgasht street, Azadi avenue
City
Tabriz
Postal code
Approval date
2013-04-17, 1392/01/28
Ethics committee reference number
552/4/5
Health conditions studied
1
Description of health condition studied
Infertility
ICD-10 code
N97.0
ICD-10 code description
Female infertility associated with anovulation
Primary outcomes
1
Description
Pregnancy rate
Timepoint
17 days after IUI
Method of measurement
Pregnancy test
Secondary outcomes
1
Description
Pregnancy rate in group with doing IUI with Injecting HCG simultaneously
Timepoint
17th day of the menstrual cycle
Method of measurement
Measurement of serum B-HCG
Intervention groups
1
Description
Inject a dose of 5000 IU HCG
Category
Treatment - Drugs
2
Description
Progesterone vaginal suppositories 400 mg every night is a number (the same night IUI) administered for 16 days
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Alzahra hospital
Full name of responsible person
Dr. Kobra Hamdi
Street address
Alzahra hospital, Artesh jonoobi avenue
City
Tabriz
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice chancellor for research,Tabriz University of Medical Scienes
Full name of responsible person
Dr. Alireza Ostad Rahimi
Street address
Tabriz university of medical sciences, Golgasht street
City
Tabriz
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 Scienes
Proportion provided by this source
100
Public or private sector
empty
Domestic or foreign origin
empty
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
empty
Person responsible for general inquiries
Contact
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Dr. Kobra Hamdi
Position
Associate professor
Other areas of specialty/work
Street address
Tabriz university of medical sciences, Golgasht street
City
Tabriz
Postal code
5138665793
Phone
+98 41 1553 9161
Fax
Email
hamdik@tbzmed.ac.ir; wrhrcenter@gmail.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Dr. Kobra Hamdi
Position
Associate professor
Other areas of specialty/work
Street address
Tabriz university of medical sciences, Golgasht street
City
Tabriz
Postal code
5138665793
Phone
+98 41 1553 9161
Fax
Email
hamdik@tbzmed.ac.ir; wrhrcenter@tbzmed.ac.ir
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Dr. Kobra Hamdi
Position
Associte professor
Other areas of specialty/work
Street address
Tabriz university of medical sciences, Golgasht street, Azadi avenue
City
Tabriz
Postal code
5138665793
Phone
+98 41 1553 9161
Fax
Email
hamdik@tbzmed.ac.ir; wrhrcenter@gmail.com
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)