In our study 300 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:IRCT2014122316705N4
Registration date:2015-01-08, 1393/10/18
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2015-01-08, 1393/10/18
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
Infertility and Reproductive Health research center, Shahid Beheshti University of Medical Sciences
Expected recruitment start date
2014-11-24, 1393/09/03
Expected recruitment end date
2016-01-20, 1394/10/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effect of sonohysterography on ART success rate in infertile women
Public title
Effect of sonohysterography on ART success rate
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: Eeach women who is candidate for assisted reproductive technology (ART); agree to participate in this study
Exclusion criteria: disagreement with participation in this study; any systematic or psycologic disease
Age
From 18 years old to 45 years old
Gender
Female
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
300
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Single 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
2014-11-23, 1393/09/02
Ethics committee reference number
0400/6864
Health conditions studied
1
Description of health condition studied
Infertility in healthy Women
ICD-10 code
ICD-10 code description
Primary outcomes
1
Description
Pregnancy
Timepoint
2 week 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 17-19 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
Treatment - Other
2
Description
Sonohystrography done in the intervention group in day 19 to 21 cycles
Category
Treatment - Other
3
Description
In the control group,in day 19-21 of cycle transvaginal sonography is done
Category
Other
Recruitment centers
1
Recruitment center
Name of recruitment center
Infertility Center, Mahdieh Hospital
Full name of responsible person
zahra heidar
Street address
Fadaeean Eslam street, Shoosh square
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
Taleghani 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