Red color represents old content. It may be empty showing addition in the new version.
Green color represents new content. It may be empty showing deletion in the new version.
Inline
Side by side
Added new contents,
deleted old contents,contents that are not changed.
New table contents
New table contents
Old table contents
Old table contents
Unchanged contents
Unchanged contents
Added new contents, contents that are not changed.
Deleted old contents, contents that are not changed.
Old table contents
Old table contents
Unchanged contents
Unchanged contents
New table contents
New table contents
Unchanged contents
Unchanged contents
General information
empty
150
150
empty
2017-09-11, 1396/06/20
2017-09-11 00:00:00
empty
2020-07-22, 1399/05/01
2020-07-22 00:00:00
empty
2020-10-30, 1399/08/09
2020-10-30 00:00:00
Recruitment centers
#1
Name of recruitment center - English: Arash Women's Hospital
Name of recruitment center - Persian: بیمارستان جامع بانوان آرش
Full name of responsible person - English: Masoomeh Nataj-Mjd
Full name of responsible person - Persian: معصومه نتاج مجد
Street address - English: Arash Women 's Hospital, Rashid avenue; Resalat highway, Tehranpars
Street address - Persian: بزرگراه رسالت ،تهرانپارس، خیابان رشید، بیمارستان بانوان آرش
City - English: Tehran
City - Persian: تهران
Province: Tehran
Country: Iran (Islamic Republic of)
Postal code: 1653915981
Phone: +98 21 7771 9922
Fax:
Email: hosparash@tums.ac.ir
Web page address:
Name of recruitment center - English: Arash Women's Hospital
Name of recruitment center - Persian: بیمارستان جامع بانوان آرش
Full name of responsible person - English: Masoomeh Nataj-Mjd
Full name of responsible person - Persian: معصومه نتاج مجد
Street address - English: Arash Women 's Hospital, Rashid avenue; Resalat highway, Tehranpars
Street address - Persian: بزرگراه رسالت، تهرانپارس، خیابان رشید، بیمارستان بانوان آرش
City - English: Tehran
City - Persian: تهران
Province: Tehran
Country: Iran (Islamic Republic of)
Postal code: 1653915981
Phone: +98 21 7771 9922
Fax:
Email: hosparash@tums.ac.ir
Web page address:
Name of recruitment center - English: Arash Women's Hospital Name of recruitment center - Persian: بیمارستان جامع بانوان آرش Full name of responsible person - English: Masoomeh Nataj-Mjd Full name of responsible person - Persian: معصومه نتاج مجد Street address - English: Arash Women 's Hospital, Rashid avenue; Resalat highway, Tehranpars Street address - Persian: بزرگراه رسالت،تهرانپارس، خیابان رشید، بیمارستان بانوان آرش City - English: Tehran City - Persian: تهران Province: Tehran Country: Iran (Islamic Republic of) Postal code: 1653915981 Phone: +98 21 7771 9922 Fax: Email: hosparash@tums.ac.ir Web page address:
Sponsors / Funding sources
#1
Name of organization / entity - English:
Name of organization / entity - Persian:
Full name of responsible person - English: Dr. Mohammad Ali Sahraeeyan
Full name of responsible person - Persian: دکتر محمد علی صحرائیان
Street address - English: Qods street; Keshavarz boulevard
Street address - Persian: بولوار کشاورز .خیابان قدس
City - English: Tehran
City - Persian: تهران
Province: Tehran
Country: Iran (Islamic Republic of)
Postal code: 1417653761
Phone: +98 21 6649 2271
Fax:
Email: vcr@tums.ac.ir
Web page address:
Name of organization / entity - English:
Name of organization / entity - Persian:
Full name of responsible person - English: Dr. Mohammad Ali Sahraeeyan
Full name of responsible person - Persian: دکتر محمد علی صحرائیان
Street address - English: Qods street, Keshavarz boulevard
Street address - Persian: بولوار کشاورز، خیابان قدس
City - English: Tehran
City - Persian: تهران
Province: Tehran
Country: Iran (Islamic Republic of)
Postal code: 1417653761
Phone: +98 21 6649 2271
Fax:
Email: vcr@tums.ac.ir
Web page address:
Name of organization / entity - English: Name of organization / entity - Persian: Full name of responsible person - English: Dr. Mohammad Ali Sahraeeyan Full name of responsible person - Persian: دکتر محمد علی صحرائیان Street address - English: Qods street;, Keshavarz boulevard Street address - Persian: بولوار کشاورز .، خیابان قدس City - English: Tehran City - Persian: تهران Province: Tehran Country: Iran (Islamic Republic of) Postal code: 1417653761 Phone: +98 21 6649 2271 Fax: Email: vcr@tums.ac.ir Web page address:
Protocol summary
Study aim
Determine the effect of nifedipine administration before embryo transfer on pregnancy rate of patients undergoing IVF.
Design
This is a randomized, double-blind, single-center clinical trial.
Two arm parallel-group randomized trial with blinded outcome assessment, Phase 3 on 158 patients.
Settings and conduct
This clinical trial will be carried out on 158 women aged 20-39 years who attended to the Infertility Treatment Center of Arash Women's Hospital, Tehran, Iran. Participants were randomly assigned into 2 groups using block randomization method. Block randomization was conducted using sealed envelope, and the randomization list was prepared by the statistician. In this study, the outcome assessors and our statistician who analyzed the data were blinded.
Participants/Inclusion and exclusion criteria
Inclusion criteria: 20-39 years of age, BMI =18-29 and the American Society Anesthesiologist physical status classification system I.
Non-inclusion criteria: women with hypertension, hypotension, abnormal uterine cavity, contraindication for the use of estrogen, progesterone, and Nifedipine, the use of drugs interacted with cytochrome P450 within 3 months before the study, serum follicle-stimulating hormone level > 20 mlU/ml on days 2-4 of the menstrual cycle, and irregular heartbeat.
Intervention groups
Intervention group: intake of oral nifedipine tablets, 20 Mg, 30 minutes before embryo transfer. Control group: No intervention
Main outcome variables
Clinical pregnancy; chemical pregnancy
General information
Reason for update
Mismatch between IRCT and article due to blindness and randomization, inclusion and exclusion criteria, secondary results and correction of ethic code.
Acronym
IRCT registration information
IRCT registration number:IRCT20140111016162N3
Registration date:2020-06-26, 1399/04/06
Registration timing:registered_while_recruiting
Last update:2022-12-15, 1401/09/24
Update count:3
Registration date
2020-06-26, 1399/04/06
Registrant information
Name
Masoomeh Nataj Majd
Name of organization / entity
Arash Womens Hospital, Tehran Medical University
Country
Iran (Islamic Republic of)
Phone
+98 21 7771 9922
Email address
hosparash@tums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2017-09-11, 1396/06/20
Expected recruitment end date
2020-07-22, 1399/05/01
Actual recruitment start date
2017-09-11, 1396/06/20
Actual recruitment end date
2020-07-22, 1399/05/01
Trial completion date
2020-10-30, 1399/08/09
Scientific title
Assessment of Nifedipine administration before fetus transfering in IVF on the rate of pregnancy in infertile women
Public title
Assessment of nifedipine administration in assisted reproductive technology on the rate of pregnancy
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
20-39 years of age
Fresh embryo transfer
Body mass index :18-29
American Society Anesthesiologist physical status classification system I
Exclusion criteria:
History of hypertension
History of hypotension
Abnormal uterine cavity
Contraindication for the use of Estrogen and Progesterone and Nifedipine
Administration of drugs that interact with cytochrome P450 activity including azole antifungals, cimetidine, cyclosporine, erythromycin, quinidine, terfenadine, warfarin, benzodiazepines, flecainide, imipramine, propafenone and theophylline within 3 months prior to study enrollment
Serum follicle-stimulating hormone (FSH) level >20mIU/mL on days 2-4 of the menstrual cycle
Irregular heart beat
Age
From 20 years old to 39 years old
Gender
Female
Phase
3
Groups that have been masked
Participant
Outcome assessor
Data analyser
Sample size
Target sample size:
158
Actual sample size reached:
150
Randomization (investigator's opinion)
Randomized
Randomization description
We used balanced block randomization with computer-generated sequence in blocks of 6 to recruit subject in each arm. We used the ratio of 1:1 to allocate subjects in each arm.
Blinding (investigator's opinion)
Double blinded
Blinding description
A randomization list is prepared by the statistician. In this process, randomization control trial medicine was placed in similar packets. The sequence of medicine administration and the list of random allocation were not disclosed to dispensing practitioners. These packets were handed over to the dispensing nurse, who was unaware of the contents of each packet. When the doctor declares the eligibility of patients, the nurse then distributes the packets based on the identification numbering. Fulfillment of the final data is up to the individual who is unaware of the type of treatment.
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Tehran University of Medical Sciences
Street address
Qods street, Keshavarz boulevard
City
Tehran
Province
Tehran
Postal code
1417653761
Approval date
2016-12-07, 1395/09/17
Ethics committee reference number
IR.TUMS.MEDICINE.REC.1395.1177
Health conditions studied
1
Description of health condition studied
Infertility
ICD-10 code
N97
ICD-10 code description
Female infertility
Primary outcomes
1
Description
Clinical pregnancy
Timepoint
4 weeks after embryo transfer
Method of measurement
Ultrasonography
2
Description
Chemical pregnancy
Timepoint
14 days after embryo transfer
Method of measurement
BHCG test
Secondary outcomes
1
Description
Blood pressure Variation
Timepoint
In three intervals including at the time of anesthesia induction, end of anesthesia, and in recovery time
Method of measurement
With a pressure gauge
2
Description
Implantation rate
Timepoint
In pregnancy
Method of measurement
The implantation rates will calculated as the number of gestational sacs divided by the number of embryos transferred to the uterus
3
Description
Multiple pregnancy rate
Timepoint
After pregnancy
Method of measurement
Ultrasonography
Intervention groups
1
Description
Intervention group: Participants receive oral nifedipine tablets ,20 Mg single dose 30 minutes before embryo transfer.
Category
Treatment - Drugs
2
Description
Control group: no intervention
Category
N/A
Recruitment centers
1
Recruitment center
Name of recruitment center
Arash Women's Hospital
Full name of responsible person
Masoomeh Nataj-Mjd
Street address
Arash Women 's Hospital, Rashid avenue; Resalat highway, Tehranpars
City
Tehran
Province
Tehran
Postal code
1653915981
Phone
+98 21 7771 9922
Email
hosparash@tums.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Dr. Mohammad Ali Sahraeeyan
Street address
Qods street, Keshavarz boulevard
City
Tehran
Province
Tehran
Postal code
1417653761
Phone
+98 21 6649 2271
Email
vcr@tums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?