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The effect of hysteroscopy on Successful pregnancy in IVF in the infertile women who are candidate for the first IVF cycle

Protocol summary

Summary
This is a randomized control clinical trial study, which study the effectiveness of hysteroscopy in the first IVF. Patients who have inclusion criteria ( Age less than 38 years, 35> BMI, didn’t do Hysteroscopy in two past month, Absence of uterine and tubal pathology which is incurable by Hysteroscopy, couples undergoing ART with their own gametes). Patients who are referred to Shariati Hospital, will be selected for this study. The number of participants are 220. Patients randomly will be divided into two groups of 110. For both groups Long Protocol will begin. Group 1: within 14 days prior to IVF, hysteroscopy will be done and if they have pathology in uterine will be corrected in that time. Group 2: include 110 individuals who will not do hysteroscopy before IVF. Two weeks after IVF, beta- hcg wil bel checked and then two weeks later, ultrasound examination to diagnose EP, miscarriage, multiple poles, embryonic and fetal heart. the results We will be compared by each others .results will be analyzed by SPSS software.

General information

Acronym
IRCT registration information
IRCT registration number: IRCT2014052616912N4
Registration date: 2014-08-01, 1393/05/10
Registration timing: registered_while_recruiting

Last update:
Update count: 0
Registration date
2014-08-01, 1393/05/10
Registrant information
Name
Saeedeh Gharahjeh
Name of organization / entity
ٰTehran University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 21 8873 6218
Email address
s-gharahgeh@razi.tums.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice chancellor for research, Tehran university of medical scince
Expected recruitment start date
2014-05-24, 1393/03/03
Expected recruitment end date
2014-08-22, 1393/05/31
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of hysteroscopy on Successful pregnancy in IVF in the infertile women who are candidate for the first IVF cycle
Public title
The effect of hysteroscopy prior IVF on creating successful pregnancy
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: Age less than 38 years; 35> BMI, didn’t do Hysteroscopy in two past month, Absence of uterine and tubal pathology which is incurable by Hysteroscopy, couples undergoing ART with their own gametes Exclusion criteria: Embryo Donation; Oocyte donation, TESE, Hypothalamic amenorrhea, OHSS, Sever male factor, 35< BMI, do Hysteroscopy in two past month, age Equal and more than 38 years; History of IVF, uterine and tubal pathology which is incurable by Hysteroscopy
Age
From 20 years old to 38 years old
Gender
Female
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size: 220
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
Tehran University of Medical Sciences
Street address
Medical ethics committee, sixth floor, university central organization, Ghods street,Keshavarz avenue
City
Tehran
Postal code
14114
Approval date
2014-05-24, 1393/03/03
Ethics committee reference number
130/446/د/93

Health conditions studied

1

Description of health condition studied
Infertility
ICD-10 code
N97.9
ICD-10 code description
Female infertility, unspecified

Primary outcomes

1

Description
Chemical pregnancy
Timepoint
Two week after IVF
Method of measurement
Check βHCG

Secondary outcomes

1

Description
Clinical pregnancy
Timepoint
4 weak after IVF
Method of measurement
Vaginal sonography

Intervention groups

1

Description
In the control group: no intervention will be done
Category
N/A

2

Description
In the intervention group, hysteroscopy is performed within 14 days prior to in vitro fertilization and If there is an abnormality in the uterine cavity , we will correct that,at the same hysteroscopy
Category
Treatment - Surgery

Recruitment centers

1

Recruitment center
Name of recruitment center
Shariati Hospital
Full name of responsible person
Amene Abiri
Street address
Infertility department, second floor, Shariati Hospital, Jalal al ahmad avenue, tehran
City
Tehran

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Vice Chancellor for Research , Tehran University of Medical Sceince
Full name of responsible person
Dr Akbar Fotouhi
Street address
Vice Chancellor for Research ,second floor, Tehran University of Medical Scince, 16 Azar avenue, Keshavarz Boulevard, Tehran
City
Tehran
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 , Tehran University of Medical Sceince
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
Tehran University Medical Sciences
Full name of responsible person
Amene Abiri
Position
Resident in Obstetrics and Gynecology (Fourth year)
Other areas of specialty/work
Street address
Infertility department, Second floor, Shariati Hospital, Jalal al ahmad avenue, tehran
City
Tehran
Postal code
14114
Phone
+98 21 8490 2421
Fax
+98 88220050
Email
abiriir@yahoo.comfsarvi@Razi.tums.ac.irs-gharahgeh@razi.tums.ac.ir
Web page address

Person responsible for scientific inquiries

Contact
Name of organization / entity
Tehran University Medical Sciences
Full name of responsible person
Amene Abiri
Position
Resident in Obstetrics and Gynecology (Fourth year)
Other areas of specialty/work
Street address
Infertility department, second floor, Shariati Hospital, Jalal al ahmad avenue, tehran
City
Tehran
Postal code
14114
Phone
+98 21 8490 2421
Fax
+98 88220050
Email
abiriir@ yahoo.coms-gharahgeh@razi.tums.ac.irfsarvi@Razi.tums.ac.ir
Web page address

Person responsible for updating data

Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Amene Abiri
Position
Resident in Obstetrics and Gynecology (Fourth year
Other areas of specialty/work
Street address
Infertility department, second floor, Shariati Hospital, Jalal al ahmad avenue, tehran
City
Tehran
Postal code
14114
Phone
+98 21 8490 2421
Fax
+98 88220050
Email
abiriir@ yahoo.coms-gharahgeh@razi.tums.ac.irfsarvi@Razi.tums.ac.ir
Web page address

Sharing plan

Deidentified Individual Participant Data Set (IPD)
empty
Study Protocol
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Statistical Analysis Plan
empty
Informed Consent Form
empty
Clinical Study Report
empty
Analytic Code
empty
Data Dictionary
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