The effect of nifedipine on the success of embryo transfer cycles in patients with recurrent implantation failure
Design
In a clinical trial, a group of 60 patients with a history of recurrent fetal implant failure will be screened before and after.
Settings and conduct
In this study, we will investigate the effect of Nifedipine in the treatment of patients with recurrent implantation failure (RIF). 60 infertile women with history of RIF and systolic blood pressure ≥ 115 will enroll in this survey. Nifedipine tablet with dose of 10 mg will be administrated to the patient 2 hours before embryo transfer. Vital signs will be checked before administration of drug and every 15 min to 1 hour and every 1 hour to 4 hours. Chemical and clinical pregnancy rate will be studied in the patients.
Participants/Inclusion and exclusion criteria
Patients with a history of two or more fetal implant failures will be included in the study and will not be included in the study if there are other causes of fetal cycle failure, including uterine abnormalities such as uterine fibroids or polyps in the endometrium, immune system disorders, and coagulation system disorders.
Intervention groups
Nifedipine tablet with dose of 10 mg will be administrated to the patient 2 hours before embryo transfer.
Main outcome variables
Clinical pregnancy; Chemical pregnancy
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20130603013566N9
Registration date:2021-07-02, 1400/04/11
Registration timing:registered_while_recruiting
Last update:2021-07-02, 1400/04/11
Update count:0
Registration date
2021-07-02, 1400/04/11
Registrant information
Name
Kobra Hamdi
Name of organization / entity
Tabriz University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 41 1554 1221
Email address
hamdik@tbzmed.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2021-07-01, 1400/04/10
Expected recruitment end date
2022-04-30, 1401/02/10
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of nifedipine on the success of embryo transfer cycles in patients with recurrent implantation failure
Public title
The effect of nifedipine on the success of embryo transfer cycles in patients with recurrent implantation failure
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Age 40_20 years
Transfer of 2 or more GA or GB embryos in the current cycle
History of two or more implantation failures in IVF
Exclusion criteria:
Congenital or acquired abnormalities of the uterus
History of uterine surgery (such as myoma or adenomyosis, etc.)
Heart disease
Severe endometriosis
Age
From 20 years old to 40 years old
Gender
Female
Phase
2
Groups that have been masked
No information
Sample size
Target sample size:
60
Randomization (investigator's opinion)
N/A
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Single
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee Of Tabriz University Of Medical Sciences
Street address
Third Floor, Central Building of Number2, Golgasht Street
City
Tabriz
Province
East Azarbaijan
Postal code
5166616471
Approval date
2021-05-31, 1400/03/10
Ethics committee reference number
IR.TBZMED.REC.1400.215
Health conditions studied
1
Description of health condition studied
Infertility
ICD-10 code
N97
ICD-10 code description
Female infertility
Primary outcomes
1
Description
Chemical pregnancy
Timepoint
14 days after embryo transfer in the cleavage stage and 12 days after embryo transfer in the blastocyst stage
Method of measurement
BHCG test
2
Description
Clinical pregnancy
Timepoint
Two weeks after a positive pregnancy test
Method of measurement
Uterine ultrasound
Secondary outcomes
empty
Intervention groups
1
Description
In this study (before and after) the result of the intervention in each person will be compared with his previous transfers, ie people who did not get a positive result in previous transfer cycles, this time again with the same medication regimen and transfer method used in the cycle We will introduce the previous transfer in the embryo transfer cycle only by adding nifedipine to the treatment regimen. Nifedipine tablets will be given 2 hours before embryo transfer at a dose of 10 mg.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Alzahra Hospital
Full name of responsible person
DR.Hamdi Kobra
Street address
Alzahra Hospital, South Artesh St.,Tabriz, iran
City
Tabriz
Province
East Azarbaijan
Postal code
5138665793
Phone
+98 41 3553 9161
Email
lahroudin@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice chancellor for Research,Tabriz University Of Medical Sciences
Full name of responsible person
Dr.Mohammad Samiei
Street address
No. 2 Central Building, Tabriz University of Medical Sciences, Golgasht Street, Tabriz
City
Tabriz
Province
East Azarbaijan
Postal code
5138665793
Phone
+98 41 3335 7310
Email
research-vice@tbzmed.ac.ir
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,Tabriz University Of Medical Sciences
Proportion provided by this source
100
Public or private sector
Public
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Academic
Person responsible for general inquiries
Contact
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Kobra Hamdi
Position
Associate Professor of Obstetrics Gynecology
Latest degree
Subspecialist
Other areas of specialty/work
Gynecology and Obstetrics
Street address
Tabriz University Of Medical Sciences, Golgasht Street
City
Tabriz
Province
East Azarbaijan
Postal code
5138665793
Phone
+98 35519161
Email
lahroudin@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Kobra Hamdi
Position
Associate Professor of Obstetrics Gynecology
Latest degree
Subspecialist
Other areas of specialty/work
Gynecology and Obstetrics
Street address
Tabriz University Of Medical Sciences, Golgasht Street
City
Tabriz
Province
East Azarbaijan
Postal code
5138665793
Phone
+98 41 3553 9161
Email
lahroudin@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Kobra Hamdi
Position
Associate Professor of Obstetrics Gynecology
Latest degree
Subspecialist
Other areas of specialty/work
Gynecology and Obstetrics
Street address
Tabriz University Of Medical Sciences, Golgasht Street
City
Tabriz
Province
East Azarbaijan
Postal code
5138665793
Phone
+98 35519161
Email
lahroudin@gmail.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Undecided - It is not yet known if there will be a plan to make this available
Study Protocol
Undecided - It is not yet known if there will be a plan to make this available
Statistical Analysis Plan
Undecided - It is not yet known if there will be a plan to make this available
Informed Consent Form
Undecided - It is not yet known if there will be a plan to make this available
Clinical Study Report
Undecided - It is not yet known if there will be a plan to make this available
Analytic Code
Undecided - It is not yet known if there will be a plan to make this available
Data Dictionary
Undecided - It is not yet known if there will be a plan to make this available