Candidates for ART (ICSI ,IVF) for the first time are enrolled,with the inclusion criteria of normal hysterosonography, normal vaginal ultrasound during the past 12 months ; age between 25-40 years; absence of abnormal uterine bleeding; no past history of hysteroscopy performed in the last 6 months. Patients are going to be randomly assigned to two groups based on computerized lists. In the case group, hysteroscopy would be performed and abnormal findings like cervical and uterine anatomical disorders ,fibrosis , myoma or polyp and etc would be registered and lesions like submucosal myomas or polyps and uterine adhesions would be removed.Also an endometrial biopsy would be undertaken and the sample would be sent for histological examination . In control group hysteroscopy is not done. The ART cycle in both groups is started from the 21th day of the following menstrual cycle by prescribing 0.2 cc Suprefact( short acting GnRH analogue ) subcutaneously for at least 10 days and after beginning of the next menstrual cycle , depending on the patients third day FSH level ,induction of ovulation is started with 2-5 ampoules of 75 IU HMG or Gonal-f . After serial sonographic monitoring of follicular development , when at least two follicles> 18 mm are reported, the patient receives 10000 IU HCG and ovum pick up( OPU )is done 36 hours there after . 2 or 3 embryos are transferred on day 3 after OPU and ß-HCG is tested on the 14th day of embryo transfer to investigate biochemical pregnancy. .
General information
Acronym
IRCT registration information
IRCT registration number:IRCT201208152565N6
Registration date:2012-10-08, 1391/07/17
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2012-10-08, 1391/07/17
Registrant information
Name
Farnaz Sohrabvand
Name of organization / entity
Vali-E _Asr Reproductive Health Research Center
Country
Iran (Islamic Republic of)
Phone
+98 21 6693 9320
Email address
sohrabva@sina.tums.ac.ir
Recruitment status
Recruitment complete
Funding source
Research Council of Tehran University of Medical Sciences
Expected recruitment start date
2012-06-10, 1391/03/21
Expected recruitment end date
2014-06-10, 1393/03/20
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Evaluation of diagnostic hysteroscopy findings in patients candidate for ART (IVF, ICSI ) and its effect on pregnancy rate Compared to control group.
Public title
Evaluation of diagnostic hysteroscopy findings in patients candidate ART (IVF, ICSI )
Purpose
Treatment
Inclusion/Exclusion criteria
inclusion Criteria:Hysterosalpingography normal during the past 12 month;Normal vaginal ultrasound TVS;Age between 25-40 year;The absence of abnormal uterine bleeding (AUB) and lack of hysteroscopy performed in the last 6 months.
Exclusion Criteria:Abnormal uterine bleeding; hysteroscopy performed in the last 6 months;Abnormal Vaginal Ultrasound .
Age
From 25 years old to 40 years old
Gender
Female
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
100
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
Research Ethics Committee of Tehran University of Medical Sciences
Street address
Keshavarz Blvd Tehran University Building
City
Tehran
Postal code
Approval date
2012-08-22, 1391/06/01
Ethics committee reference number
17153
Health conditions studied
1
Description of health condition studied
Female Infertility
ICD-10 code
N.97.2
ICD-10 code description
Female infertility of uterine origin
Primary outcomes
1
Description
Pathologic findings on hysteroscopy
Timepoint
During the hysterectomy
Method of measurement
View the eyes and Biopsy
2
Description
Polip
Timepoint
During the hysteroscopy
Method of measurement
View the eyes and Biopsy
3
Description
Adhesion
Timepoint
During the hysteroscopy
Method of measurement
View the eyes and Biopsy
4
Description
Fibroma
Timepoint
During the hysteroscopy
Method of measurement
View the eyes and Biopsy
Secondary outcomes
1
Description
Impact on IVF outcomes
Timepoint
14 days after embryo transfer
Method of measurement
Blood Tests
Intervention groups
1
Description
Control Group:Hysterodcopy is not done
Category
Treatment - Devices
2
Description
In the case groupHysteroscopy is performed , submucosal myoma or polyps 1 cm or larger cervical or uterine adhesions within Chonnell ,with hysteroscopy will be resolved , If this is not possible with Resectoscopy pathology resolved and The example is sent for histological examination.In the Normal hysteroscopy, biopsy is sent for histological examination .
Category
Treatment - Other
Recruitment centers
1
Recruitment center
Name of recruitment center
Infertility center in Valie-Asr Hospital
Full name of responsible person
Dr,Farnaz Sohrabvand
Street address
Vali-E-Asr Reproductive Health Research center ,Valieasr Hospital ,Keshavarz Blvd
City
Tehran
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Research Council of Tehran University of Medical Sciences
Full name of responsible person
Dr.Younesian
Street address
Keshavarz Boulevard - The Quads - Tehran Medical University building - floors5
City
Tehran
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Research Council of Tehran University of Medical Sciences
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
Vali-e-Asr reproductive HealthnResearch center
Full name of responsible person
Farnaz Sohrabvand
Position
scientific faculty
Other areas of specialty/work
Street address
Valie -Asr Hospital
City
Tehran
Postal code
Phone
+98 21 6693 9320
Fax
Email
fsohrabvand@yahoo.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Vali-E-Asr Reproductive Health Research Center
Full name of responsible person
Farnaz Sohrabvand
Position
Scientific faculty
Other areas of specialty/work
Street address
Keshavarz Bul,Valie-Asr Hospital
City
Tehran
Postal code
Phone
+98 21 6693 9320
Fax
Email
fsohrabvand@yahoo.com
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Vali-E-Asr Reproductive Health Research Center
Full name of responsible person
Haghollahi Fedyeh
Position
M.SC
Other areas of specialty/work
Street address
Vali-E-Asr Reproductive Health Research Center ,valieasr Hospital ,Keshavarz BLvd,Tehran ,1419733141-Iran
City
Tehran
Postal code
1419733141
Phone
+98 21 6658 1616
Fax
+98 21 6658 1658
Email
fedyeh_hagh@yahoo.com
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)