Comparison of the effect of two types of soft embryo transfer catheters PM Trans Set Mini CH3 and Kitazato on the results of IVF in infertile women: a single blind randomized clinical trial
Objectives: To assess the effect of two types of soft embryo transfer catheters PM Trans Set Mini CH3 and Kitazato on the results of IVF in infertile women.
Design: a single blind randomized clinical trial.
Setting and conduct: The eligible infertile women who will refer to Fatemieh Hospital during the study period will be enrolled into the trial.
Inclusion criteria: (a) age less than 40; (b) (having more than 3 fetuses; (c) having healthy uterine cavity.
Exclusion criteria: (a) having high baseline FSH level; (b) having a history of difficult transfer; (c) having more than 6 times IVF cycle; (d) idiopathic infertility; (e) donated fetus; (f) frizzed fetus.
Intervention group: Embryo transfer using soft catheter PM Trans Set Mini CH3.
Control group: Embryo transfer using soft catheter Kitazato.
Primary outcome: (a) assessing pregnancy through measuring βhcg titer14 days after embryo transfer; (b) assessing pregnancy through transvaginal ultrasonography 4 weeks after embryo transfer.
Secondary outcome: Assessing the need to Tenaculum by checking presence of blood or mucous on the head of catheter immediately after embryo transfer.
Randomization: Random assignment of the patients to the intervention and control groups through drawing of lots.
Blinding: Patients will be unaware of the type of catheters. Therefore, the trial will be run as single blind.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT201601049014N88
Registration date:2016-01-17, 1394/10/27
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2016-01-17, 1394/10/27
Registrant information
Name
Jalal Poorolajal
Name of organization / entity
Department of Epidemiology & Biostatistics Hamadan University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 81 1838 0090
Email address
poorolajal@umsha.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice-chancellor for Research the Technology, Hamadan University of Medical Sciences
Expected recruitment start date
2015-08-23, 1394/06/01
Expected recruitment end date
2016-04-20, 1395/02/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of the effect of two types of soft embryo transfer catheters PM Trans Set Mini CH3 and Kitazato on the results of IVF in infertile women: a single blind randomized clinical trial
Public title
Comparison of the effect of two types of soft embryo transfer catheters PM Trans Set Mini CH3 and Kitazato on the results of IVF in infertile women
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: (a) age less than 40; (b) (having more than 3 fetuses; (c) having healthy uterine cavity.
Exclusion criteria: (a) having high baseline FSH level; (b) having a history of difficult transfer; (c) having more than 6 times IVF cycle; (d) idiopathic infertility; (e) donated fetus; (f) frizzed fetus.
Age
From 18 years old to 40 years old
Gender
Female
Phase
2
Groups that have been masked
No information
Sample size
Target sample size:
90
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Single blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Randomization: Random assignment of the patients to the intervention and control groups through drawing of lots.
Blinding: Patients will be unaware of the type of catheters. Therefore, the trial will be run as single blind.
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee of Hamadan University of Medical Sciences
Street address
Vice-chancellor for Research the Technology, Hamadan University of Medical Sciences, Shahid Fahmideh Ave
City
Hamadan
Postal code
6517838695
Approval date
2015-12-05, 1394/09/14
Ethics committee reference number
IR.UMSHA.REC.1394.369
Health conditions studied
1
Description of health condition studied
Infertility
ICD-10 code
N97
ICD-10 code description
Female infertility
Primary outcomes
1
Description
assessing pregnancy
Timepoint
titer14 days after embryo transfer
Method of measurement
through measuring βhcg
2
Description
assessing pregnancy
Timepoint
4 weeks after embryo transfer
Method of measurement
through transvaginal ultrasonography
Secondary outcomes
1
Description
Assessing the need to Tenaculum
Timepoint
immediately after embryo transfer
Method of measurement
by checking presence of blood or mucous on the head of catheter
Intervention groups
1
Description
Embryo transfer using soft catheter PM Trans Set Mini CH3
Category
Treatment - Devices
2
Description
Embryo transfer using soft catheter Kitazato
Category
Treatment - Devices
Recruitment centers
1
Recruitment center
Name of recruitment center
Fatemieh Hospital
Full name of responsible person
Dr Hasan Bahrami
Street address
Fatemieh Hospital, Pasdaran Ave.
City
Hamadan
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice-chancellor for Research the Technology, Hamadan University of Medical Sciences
Full name of responsible person
Dr Saeid Bashirian
Street address
Hamadan University of Medical Sciences, Shahid Fahmideh Ave
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 the Technology, Hamadan 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
Fatemieh Hospital
Full name of responsible person
Dr Hasan Bahrami
Position
Medical Student
Other areas of specialty/work
Street address
Fatemieh Hospital, Pasdaran Ave.
City
Hamadan
Postal code
Phone
+98 81 3828 3939
Fax
Email
dr.hsn.bahrami@gmail.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Fatemieh Hospital
Full name of responsible person
Dr Soghra Rabiei
Position
Gynecologist
Other areas of specialty/work
Street address
Fatemieh Hospital, Pasdaran Ave.
City
Hamadan
Postal code
Phone
+98 81 3828 3939
Fax
Email
rabieesogol@yahoo.com
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Department of Epidemiology
Full name of responsible person
Dr Jalal Poorolajal
Position
Associate Professor
Other areas of specialty/work
Street address
School of Public Health, Hamadan University of Medical Sciences, Shahid Fahmideh Ave
City
Hamadan
Postal code
6517838695
Phone
+98 81 3838 0090
Fax
Email
poorolajal@umsha.ac.ir
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)