In our study 100 women , who are candidate for ART(assisted reproductive technology) randomly are divided into two groups.In case group SHG (hystrosonogram) is done in midluteal phase before stimulation cycle and in controls only TVS (transvaginal ultrasound) is done then from day 2 or 3 of mense controlled ovarian hyperstimulation with gonadotropin injection is started. Gonadotropin dosage is based on age and ovarian reserve (based on infertility ward protocol) and under TVS control follicular growth monitoring is done. In follicular size of 17-18 mm HCG (human chorionic gonadotropin) 10000 IU is injected and 35-36 h leter ovum pick up is done. After 2 or 3 days embryo is transferred . Pregnancy test is requested 2 weeks later, and finally pregnancy rate in two groups is evaluated.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2014022416705N1
Registration date:2014-06-26, 1393/04/05
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2014-06-26, 1393/04/05
Registrant information
Name
zahra heidar
Name of organization / entity
sbmu
Country
Iran (Islamic Republic of)
Phone
+98 21 4461 2416
Email address
dr_zheidar@sbmu.ac.ir
Recruitment status
Recruitment complete
Funding source
Shahid Beheshti University of Medical Sciences
Expected recruitment start date
2014-06-22, 1393/04/01
Expected recruitment end date
2015-01-20, 1393/10/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effect of sonohystrography on increasing pregnancy rate in assisted reproductive technology cycle
Public title
Effect of sonohystrography on pregnancy rate in assisted reproductive technology cycles
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: Eeach women who is candidate for assisted reproductive technology (ART); and agree to participate in this study
Exclusion criteria: disagreement with participation in this study; any somatic or psycologic disease
Age
From 20 years old to 45 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
Shahid Beheshti University of Medical Sciences ethics committee
Street address
Shahid Beheshti University of Medical Sciences , velenjak
City
Tehran
Postal code
Approval date
2014-03-11, 1392/12/20
Ethics committee reference number
149
Health conditions studied
1
Description of health condition studied
Infertility treatment in healthy women
ICD-10 code
z30-z39
ICD-10 code description
Persons encountering health services in circumstances related to reproduction
Primary outcomes
1
Description
Pregnancy
Timepoint
2 weeks after embryo transfer
Method of measurement
Pregnancy test
Secondary outcomes
empty
Intervention groups
1
Description
In case group hysterosonogram with normal saline is done in midluteal phase before stimulation cycle.Then ovarian stimulation with gonadotropins is started from day 2-3 of cycle and with TVS (transvaginal ultrasound ) follicular growth is monitored, in follicular size 17-18 mm HCG (human chorionic gonadotropin) 10000 IU inject and 35-36 h after that ovarian puncture is done.2-3 day later embryo transfer is done and 14 days later pregnancy test is requested.
Category
Other
2
Description
In controls in this time (mid luteal phase) transvaginal ultrasound is done and other steps are like case group.
Category
Other
Recruitment centers
1
Recruitment center
Name of recruitment center
Mahdieh Hospital
Full name of responsible person
Street address
City
Tehran
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Infertility and Reproductive Health research center,Shahid Beheshti University of Medical Sciences
Full name of responsible person
Dr. Seied Jalil Hoseiny
Street address
Taleghany hospital ,Velenjak
City
Tehran
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Infertility and Reproductive Health research center,Shahid Beheshti 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
Person responsible for scientific inquiries
Contact
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Dr. Zahra Heidar
Position
Assistant professor
Other areas of specialty/work
Street address
Mahdieh Hospital
City
Tehran
Postal code
Phone
+98 21 5506 6288
Fax
Email
dr_zheidar@yahoo.com
Web page address
Person responsible for updating data
Contact
Sharing plan
Deidentified Individual Participant Data Set (IPD)