The goal of the study is evaluating the effect of oral ritodrine in implantation rate in patients treated with IVF-ICSI/ET. Inclusion criteria: women having a normal uterus assessed with hysterosonography or hysteroscopy; infertility due to factors pipe; infertility due to male factor unexplained. Exclusion criteria: women having a systemic diseases; infertility due to advanced pelvic endometriosis; having endometriomas greater than 2 cm. Study population are women having fertility between 20 to 35 years old and are candidate for IVF/ICSI plan. 200 of these women which are referred to Alzahra hospital, infertility ward for treatment will be randomly assigned into two intervention and control groups (100 each). treatment will stimulation of ovaries with IVF method and after removing the ovocytes and getting them fertilized in lab, transferring the embryos will be done 48 to 72 hours after gathering the oocytes. Antibiotic prophylaxis will be done by using erythromycin tablets from the time ofgathering for four days and oral ritodrine will be administered 10 mg, twice a day from one day before transferring for a week. Implantation rate was defined as the primary outcome.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT201301146868N5
Registration date:2013-03-24, 1392/01/04
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2013-03-24, 1392/01/04
Registrant information
Name
Mahzad Sadaghiani
Name of organization / entity
Tabriz University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 41 1553 9161
Email address
sadaghianim@tbzmed.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice chancellor for research,Tabriz University of Medical Sciences
Expected recruitment start date
2013-01-29, 1391/11/10
Expected recruitment end date
2014-07-01, 1393/04/10
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effects of oral ritodrine on infertility treatment
Public title
Evaluation of the effect of oral ritodrine on implantation rate of in vitro fertilization – embryo transfer cycles
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: women having a normal uterus assessed with hysterosonography or hysteroscopy; infertility due to factors pipe; infertility due to male factor unexplained. Exclusion criteria: women having a systemic diseases; infertility due to advanced pelvic endometriosis; having endometriomas greater than 2 cm.
Age
From 20 years old to 35 years old
Gender
Female
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
200
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
Tabriz university institutional ethics review board
Street address
Azadi avenue, Golgasht street, Vice Chancellor for Research, Tabriz University of Medical Sciences
City
Tabriz
Postal code
Approval date
2012-06-13, 1391/03/24
Ethics committee reference number
2829/4/5
Health conditions studied
1
Description of health condition studied
infertility
ICD-10 code
N97
ICD-10 code description
Female Infertility
Primary outcomes
1
Description
Successful implantation
Timepoint
Two weeks after embryo transfer
Method of measurement
Increased hormone levels in the blood βHCG
Secondary outcomes
1
Description
The number and quality of oocytes and embryos, embryo transfer quality and results βHCG
Timepoint
Two weeks after embryo transfer
Method of measurement
Increased βHCG
Intervention groups
1
Description
In the intervention group Ritodrine pill 10mg, BID will be administered from the day before embryo transfer and continued for 6 days.
Category
Treatment - Drugs
2
Description
In control group no intervention will be done.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Alzahra Hospital
Full name of responsible person
Dr. Mahzad Mehrzad Sadaghiani
Street address
Alzahra Hospital, Bagh-shomal, Arteshe-e-Jonoubi street
City
Tabriz
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Vice Chancellor of research
Street address
Tabriz University of Medical Siences, Golgasht Street, Azadi Avenue
City
TABRIZ
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Tabriz 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
Tabriz University of Medical Sciences
Full name of responsible person
Mahzad Mehrzad Sadaghiani
Position
Associte Proffesor
Other areas of specialty/work
Street address
Alzahra Hospital, bagh-shomal, Arteshe-e-Jonoubi Street