Inclusion criteria: all women aged 15 to 45 who refer to Kosar infertility center who have frozen fetus and are candidates for embryo transfer treatment. Exclusion criteria: BMI>38; early stage of follicular phase; any kind of contraindication for pregnancy or continuing the pregnancy until the term; contraindications to consumption of Nifedipin, Estradiol or Progestron; arrhythmia; taking drugs that interfere with cytochrome p450; treatment with other blood pressure medications.
Intervention groups
Patients who have undergone ICSI at the Kowsar Infertility Center and for some reason have a frozen fetus are given half a milligram of nifedipine tablets half an hour before the placement of the frozen embryos, and its effectiveness in suppressing uterine contractions and the success of transplanted embryo replacement is evaluated.
Main outcome variables
Uterin contractions
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20210227050515N1
Registration date:2021-04-30, 1400/02/10
Registration timing:registered_while_recruiting
Last update:2021-04-30, 1400/02/10
Update count:0
Registration date
2021-04-30, 1400/02/10
Registrant information
Name
Rana Razavi dizaji
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 44 3366 6250
Email address
razavi.r@umsu.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2021-04-09, 1400/01/20
Expected recruitment end date
2021-06-21, 1400/03/31
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Assessing the effect of nifedipine on success of embryo placement in infertile women who have been candidates for laboratory treatment
Public title
Assessing of effect of nifedipine on IVF
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Having a frozen embryo and a candidate for embryo transfer
Patients who are candidates for infertility treatment other than in vitro fertilization
Exclusion criteria:
Patients who are candidates for infertility treatment other than in vitro fertilization
BMI>38
Contraindications to the use of nifedipine and estrogen or progesterone
Patients treated with other drugs that interfere with nifedipine
Age
From 15 years old to 45 years old
Gender
Female
Phase
2-3
Groups that have been masked
Participant
Sample size
Target sample size:
50
Randomization (investigator's opinion)
Randomized
Randomization description
Patients are divided into two groups and based on the day of referral, they are placed in the control and intervention group. The referring patients will be given drug before transfers on even days of the week and will be placed in the intervention group. Patients will not be given any medication on odd days of the week and will be in the control group.
Blinding (investigator's opinion)
Single blinded
Blinding description
Patients are divided into two groups and in order to prevent psychological stress, patients are given medicine to people who have visited on even days and patients are not given any medicine before transfer on individual days of the week.
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Urmia University of Medical Sciences Ethics Committee
Street address
Urmia University of Medical Sciences, Nazlu
City
Orumie
Province
West Azarbaijan
Postal code
5714783734
Approval date
2018-11-14, 1397/08/23
Ethics committee reference number
IR.UMSU.REC.1397.324
Health conditions studied
1
Description of health condition studied
Infertility
ICD-10 code
N97
ICD-10 code description
Female infertility
Primary outcomes
1
Description
Beta HCG test positive rate after IVF
Timepoint
Two weeks after IVF
Method of measurement
Beta HCG test
Secondary outcomes
empty
Intervention groups
1
Description
IVF candidates who have a frozen fetus and are referred to Kowsar Infertility Center are divided into two groups and the intervention group is given nifedipine transfer at a dose of 5 mg orally half an hour before taking blood pressure after taking blood pressure. Patients will be given medication every other day due to psychological stress in the two groups receiving the drug and the group that did not receive the drug.
Category
Treatment - Devices
2
Description
Control group: patients entering the control group will not be given any medication and no intervention will be performed.
Category
Diagnosis
Recruitment centers
1
Recruitment center
Name of recruitment center
Kosar Infertility clinic of Motahari hospital
Full name of responsible person
Rana Razavi Dizaji
Street address
Kosar infertility center, Motahari hospital, Kashani street
City
Orumia
Province
West Azarbaijan
Postal code
5714783734
Phone
+98 44 3223 4897
Fax
+98 44 3223 4897
Email
Razavi.r@umsu.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Oroumia University of Medical Sciences
Full name of responsible person
Iraj Mohebbi
Street address
Vince chancellor for research and technology .West Azarbaijan university of medical science an health service.Resalt Blvd
City
Orumie
Province
West Azarbaijan
Postal code
57147837734
Phone
+98 44 3223 1930
Fax
+98 44 3224 0642
Email
mohebbi_iraj@yahoo.co.uk
Grant name
Vice Chancellor for Research, Urmia University of Medical Sciences
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Oroumia 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
Oroumia University of Medical Sciences
Full name of responsible person
Rana Razavi Dizaji
Position
Gynacologyst
Latest degree
Specialist
Other areas of specialty/work
Gynecology and Obstetrics
Street address
Motahari hospital, Kashani St.
City
Orumia
Province
West Azarbaijan
Postal code
5714783734
Phone
+9844322234896
Fax
+98 44 3197 7149
Email
Razavi.r@umsu.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Oroumia University of Medical Sciences
Full name of responsible person
Masumeh Haj Shafi ha
Position
Gyancologyst
Latest degree
Specialist
Other areas of specialty/work
Gynecology and Obstetrics
Street address
Motahari hospital, Kashani St.
City
Orumia
Province
West Azarbaijan
Postal code
5714783734
Phone
+98 914 345 9380
Fax
+98 44 3197 7149
Email
Razavi.r@umsu.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Oroumia University of Medical Sciences
Full name of responsible person
Rana Razavi Dizaji
Position
ob/gynacologyst
Latest degree
Specialist
Other areas of specialty/work
Gynecology and Obstetrics
Street address
Motahari hospital, Kashani St.
City
Orumie
Province
West Azarbaijan
Postal code
5714783734
Phone
+98 44 3223 4897
Fax
Email
Razavi.r@umsu.ac.it
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