110 infertile women candidate intrauterine insemination, enrolled in our clinical trial. All of them have normal hystero salpangography. Randomly divided into two equal group.
First group underwent hysteroscopy before intrauterine insemination and depend on finding, candidated for surgery. Second group took intrauterine insemination without hysteroscopy. In group 1 if patient had normal hysteroscopy, took IUI at next cycle; If had surgery due to hysteroscopy finding, took IUI after 2-3 cycle.
In order to ovarian stimulation in both groups, Clomifen 50-100g/d started and after 3 days intra venous injection of HMG (75 unit per day) started. Between 12th and 14th day, trans vaginal sonography had been done; if follicles were about 18-20 mm, single dose of HCG would inject. After 36 hours, IUI would have done and 2 week later, B-HCG would be checked.
Vaginal sonography had been done to confirm pregnancy and fetus condition 6 weeks after IUI. All patients followed up during 3 cycle up to 6 month.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT201201308867N1
Registration date:2012-04-09, 1391/01/21
Registration timing:retrospective
Last update:
Update count:0
Registration date
2012-04-09, 1391/01/21
Registrant information
Name
Sarah sadat Barati
Name of organization / entity
Jundi Shapur University of Medical Sciences, Ahwaz
Country
Iran (Islamic Republic of)
Phone
+98 61 1223 9820
Email address
barati.s@ajums.ac.ir
Recruitment status
Recruitment complete
Funding source
Jundi Shapur University of Medical Sciences, Ahwaz
Expected recruitment start date
2011-03-30, 1390/01/10
Expected recruitment end date
2011-05-31, 1390/03/10
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effect of hysteroscopy before Intra uterine insemination on fertility in infertile couples patients referred to Imam Khomeini Hospital, Ahwaz IVF
Public title
Effect of hysteroscopy before Intra uterine insemination on fertility in infertile couples
Purpose
Other
Inclusion/Exclusion criteria
Inclusion criterion: all infertile patients who are candidates for IUI with normal Hysterosalpangography. Exclusion criterion: ovarian hyperstimulation syndrome in patients suffering complications during surgery and Hysteroscopy.
Age
From 20 years old to 40 years old
Gender
Female
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
110
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
Jundi Shapur University of Medical Sciences, Ahwaz
Street address
Golestan Blvd - University of Medical Sciences, Ahwaz Jondi Shapur
City
Ahwaz
Postal code
Approval date
2011-01-21, 1389/11/01
Ethics committee reference number
ETH-350
Health conditions studied
1
Description of health condition studied
Infertility
ICD-10 code
ICD-10 code description
Primary outcomes
1
Description
Pregnancy
Timepoint
Two months after intervention
Method of measurement
Transvaginal ultrasonography
Secondary outcomes
1
Description
Complications of hysteroscopy and treatment side effects of ovulation
Timepoint
After hysteroscopy and during treatment for ovulation
Method of measurement
Monitoring vital signs and clinical symptoms
Intervention groups
1
Description
Hysteroscopy
Category
Diagnosis
2
Description
No Hysteroscopy
Category
N/A
Recruitment centers
1
Recruitment center
Name of recruitment center
IVF department of Imam Khomeini Hospital, Ahwaz
Full name of responsible person
Street address
City
Ahwaz
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Jundi Shapur University of Medical Sciences, Ahwaz
Full name of responsible person
Dr. Mostafa feqhi
Street address
Golestan Blvd - University of Medical Sciences, Ahwaz Jondi Shapur
City
Ahwaz
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Jundi Shapur University of Medical Sciences, Ahwaz
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
Jundi Shapur University of Medical Sciences, Ahwaz
Full name of responsible person
Dr. Farideh Maramazi
Position
Infertility Fellowship / Assistant Professor
Other areas of specialty/work
Street address
Imam Khomeini Hospital - IVF Department
City
Ahwaz
Postal code
Phone
+98 61 1222 2114
Fax
Email
maramazi.f@ajums.ac.ir
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Jundi Shapur University of Medical Sciences, Ahwaz
Full name of responsible person
Dr. Farideh Maramazi
Position
Infertility Fellowship / Assistant Professor
Other areas of specialty/work
Street address
Imam Khomeini Hospital - IVF Department
City
Ahwaz
Postal code
Phone
+98 61 1222 2114
Fax
Email
maramazi.f@ajums.ac.ir
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Jundi Shapur University of Medical Sciences, Ahwaz
Full name of responsible person
Doctor Sarahsadat Barati
Position
Resident of Obstetrics and Gynecology
Other areas of specialty/work
Street address
City
Postal code
Phone
00
Fax
Email
barati.s@ajums.ac.ir
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)