Evaluation of effect of oral Ritodrine on implantation rate in the in vitro fertilization (IVF)+ embryo transfer (ET) cycles in the infertile women: a randomized controlled trial
Background: Pregnancy rate with IVF cycle is almost 22%. Many investigations perform to increase the IVF result. Various factors affect on the result of IVF cycles and increasing the pregnancy rate as well. One of these factors could be uterine contractions that expel transferred embryo. Ritodrine is a Beta mimetic agent that can block and decrease uterine contractions and consequently increases implantation rate of embryo. Objective: The objective of this study was to determine effectiveness of ritodrine for increasing the implantation rate in IVF cycles and embryo transfer.
Materials and methods: A total of 100 patients of IVF+ ET cycles were divided randomly in two groups in Fatemieh university hospital, Hamadan. The case group were prescribed ritodrine 10 mg / bid orally after oocyte retrieval until 10 day in addition to usual drugs: ASA, progestrone, folic acid and erythromycin according to protocol. In the control group prescribed only usual drugs including: ASA, progestrone, folic acid and erythromycin. Ovulation stimulation protocol, puncture and embryo transfer were same in both groups. Evaluation of beta hCG by radioimmunoassay and embryo implantation by sonography were done for each group 12 days after intervention.
Inclusion criteria: having a morphologically normal uterus; infertility from tubal; male, endometriosis or unexplained factors; infertility over than 5 years. Excluding criteria: existing the known systemic diseases in both groups
General information
Acronym
IRCT registration information
IRCT registration number:IRCT201105316665N1
Registration date:2011-07-24, 1390/05/02
Registration timing:retrospective
Last update:
Update count:0
Registration date
2011-07-24, 1390/05/02
Registrant information
Name
Soghra Rabiee
Name of organization / entity
Hamadan University of Medical Science
Country
Iran (Islamic Republic of)
Phone
+98 81 1822 3991
Email address
rabiei@umsha.ac.ir
Recruitment status
Recruitment complete
Funding source
Hamadan University of Medical Science- Vice Chancellor for Research
Expected recruitment start date
2007-04-04, 1386/01/15
Expected recruitment end date
2008-04-18, 1387/01/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Evaluation of effect of oral Ritodrine on implantation rate in the in vitro fertilization (IVF)+ embryo transfer (ET) cycles in the infertile women: a randomized controlled trial
Public title
infertility treatment
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: having a morphologically normal uterus; infertility from tubal; male, endometriosis or unexplained factors; infertility over than 5 years. Excluding criteria: existing the known systemic diseases in both groups
Age
From 25 years old to 45 years old
Gender
Female
Phase
2-3
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
1
Registry name
no
Secondary trial Id
no
Registration date
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee of Hamadan University of Medical Scinece
Street address
Opposite Mardum Park, Shahid Fahmideh Street, University of Medical Science
City
Hamadan
Postal code
Approval date
2010-02-09, 1388/11/20
Ethics committee reference number
165749
Health conditions studied
1
Description of health condition studied
Infertility
ICD-10 code
Z31.2
ICD-10 code description
In vitro fertilization
Primary outcomes
1
Description
beta hCG
Timepoint
two weeks
Method of measurement
radioimmunoassay
Secondary outcomes
1
Description
embryo implantation
Timepoint
immediately after beta hCG positivity (two weeks after than intervention)
Method of measurement
ultrasonography
Intervention groups
1
Description
Intervention group:were stimulated with a GnRH agonist and exogenous gonadotropins with long protocol and were prescribed ASA, progestrone, folic acid and erythromycin. On the day after oocyte retrieval, all patients in the case group received oral ritodrine 10 mg/ bid for ten days.
Category
Treatment - Drugs
2
Description
Control group: were stimulated with a GnRH agonist and exogenous gonadotropins with long protocol and were prescribed ASA, progestrone, folic acid and erythromycin
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Infertility Treatment Center, Fatemieh Hospital, Hamadan, Iran
Full name of responsible person
Dr Soghra Rabiee
Street address
Fatemieh Hospital, Pasdaran Street, Hamadan, Iran
City
Hamadan
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice Chancellor for Research, Hamadan University of Medical Science,
Full name of responsible person
Dr Ali Ghaleiha
Street address
Chancellor for Research, Shahid Fahmideh Street, Opposite Park Mardum, Hamadan University of Medical Science
City
Hamadan
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, Hamadan University of Medical Science,
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
Hamadan University of Medical Science
Full name of responsible person
Dr Soghra Rabie
Position
Associate Professor, MD
Other areas of specialty/work
Street address
Fatemieh Hospital, Pasdaran Street, Hamadan
City
Hamadan
Postal code
Phone
+98 81 1835 3090
Fax
Email
rabiei@umsha.ac.ir; rabieesogol@yahoo.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Hamadan University of Medical Science
Full name of responsible person
Dr Soghra Rabiee
Position
Associate Prof, MD
Other areas of specialty/work
Street address
Fatemieh Women Hospital, Pasdaran Street, Hamadan, Iran
City
Hamadan
Postal code
Phone
+98 81 1835 3090
Fax
Email
rabiei@umsha.ac.ir; rabieesogol@yahoo.com
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Hamadan University of Medical Science
Full name of responsible person
Dr Soghra Rabiee
Position
Associate Professor, MD
Other areas of specialty/work
Street address
Fatemieh Hospital, Pasdaran Street, Hamadan
City
Hamadan
Postal code
6517815148
Phone
+98 81 1835 3090
Fax
Email
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)