History
# Registration date Revision Id
4 2022-12-14, 1401/09/23 249137
3 2022-11-15, 1401/08/24 246227
2 2021-07-05, 1400/04/14 189458
1 2020-06-26, 1399/04/06 140680
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  • Protocol summary

    The aim of this study is to determine the effect of nifedipine administration before embryo transfer on pregnancy rate of patients undergoing IVF.
    Determine the effect of nifedipine administration before embryo transfer on pregnancy rate of patients undergoing IVF.
    This is a randomized, single-blind, single-center clinical trial. Two arm parallel-group randomized trial with blinded outcome assessment, Phase 3 on 158 patients. We will use the block randomization method by using: www.sealedenvelope.com
    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.
    این مطالعه از نوع کارآزمایی بالینی تصادفی، یک سو کور و تک مرکزی می باشد. کارآزمایی بالینی دارای گروه کنترل، با گروه های موازی ، یک سویه کور ، تصادفی شده، فاز 3 بر روی 158 بیمار. تخصیص تصادفی نمونه ها با استفاده از روش بلاکی و با استفاده از سایت : www.sealedenvelope.com انجام خواهد شد.
    این مطالعه از نوع کارآزمایی بالینی تصادفی،دو سو کور و تک مرکزی می باشد. کارآزمایی بالینی دارای گروه کنترل، با گروه های موازی، دو سویه کور، تصادفی شده، فاز 3 بر روی 158 بیمار.
    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. The randomization list is prepared by the statistician. Medicines are placed in similar packets and the sequence of medicine administration and the list of random allocation is not disclosed to dispensing practitioners. These packets are given to the dispensing nurse, who is unaware of the contents of each packet. When the doctor declares the eligibility of patients, the nurse give packets to them according to the identification numbering. Completion of the final information is up to the person who is unaware of the type of treatment and also the specialist will be blind.
    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.
    این کارآزمایی بالینی بر 158 نفر خانم با سن 20 تا 39 سال د که به بخش نازایی بیمارستان زنان آرش در شهر تهران مراجعه می کنند انجام خواهد شد. لیست رندومیزیشن توسط متخصص امار تهیه خواهد شد داروها در پاکت های مهر و موم شده قرار داده می شود که توسط پرستار بخش که از مطالعه خارج است نگهداری خواهند شد. رضایت اخلاق گرفته می شود. سپس پرستار بخش پاکت حاوی نوع دارو را در اختیار پزشک قرار می دهد و مداخله بر اساس دارو موجود در پاکت انجام میشود.تکمیل اطلاعات نهایی بر عهده فردی میباشد که از نوع درمان بی اطلاع است. همچنین متخصص امار نیز از نوع درمان کور خواهد بود
    این کارآزمایی بالینی بر 158 نفر خانم با سن 20 تا 39 سال که به بخش نازایی بیمارستان زنان آرش در شهر تهران مراجعه می کنند انجام خواهد شد. شرکت کنندگان بصورت تصادفی با روش بلاک رندومیزیشن به دو گروه تقسیم می شوند.بلاک رندومیزیشن با پاکتهای دربسته توسط متخصص آمار تهیه می شوند. در این مطالعه فردیکه اطلاعات را جمع آوری میکند و متخصص آمار که داده ها را آنالیز میکند کور میشوند.
    Inclusion criteria: 20-39 years of age, Body mass index (BMI) =18-29 and being in class A. Non-inclusion criteria: having a history of hypertension (BP>= 140/90) or hypotension
    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.
    معیارهای ورود به مطالعه: سن 39- 20 سال، BMI بین 29- 18، قرار گرفتن در class A. معیار عدم ورود به مطالعه: وجود سابقه‌ای از پرفشاری خون (BP>=140/90)، سابقه کم فشاری خون.
    معیارهای ورود به مطالعه: سن 39- 20 سال، BMI بین 29- 18، کلاس I انجمن بیهوشی آمریکا از نظر وضعیت جسمی. معیار عدم ورود به مطالعه: بیماران با فشارخون بالا، پایین، حفره رحم غیرطبیعی، منع مصرف استروژن، پروژسترون و نیفدیپین، مصرف داروهایی که با سیتوکروم P450 تداخل دارند در سه ماه گذشته، سطح سرمی هورمون محرک فولیکول بیشتر از mlU/ml 20 در روز 2-4 سیکل قاعدگی و ضربان قلب نامنظم.
  • General information

    Triple blinded
    Double blinded
    1
    Mismatch between IRCT and article due to blindness of participants
    Mismatch between IRCT and article due to blindness and randomization, inclusion and exclusion criteria, secondary results and correction of ethic code.
    عدم تطابق بین IRCTو مقاله جهت کور بودن شرکت کنندگان
    عدم تطابق بین IRCTو مقاله جهت کور سازی، نحوه تصادفی سازی و تطابق دقیق بین معیارهای ورود و خروج و اصلاح جزیی پیامدهای ثانویه. تصحیح دقیق کد اخلاق.
    20-39 years of age
    Fresh embryo transfer
    Body mass index :18-29
    Being in class A
    20-39 years of age
    Fresh embryo transfer
    Body mass index :18-29
    American Society Anesthesiologist physical status classification system I
    سن 39- 20 سال
    انتقال جنین تازه
    شاخص توده بدنی بین 29- 18
    قرار گرفتن در class A
    سن 39- 20 سال
    انتقال جنین تازه
    شاخص توده بدنی بین 29- 18
    قرار گرفتن در کلاس I انجمن بیهوشی آمریکا از نظر وضعیت جسمی
    وجود سابقه‌ای از پرفشاری خون (BP>140/90)
    داشتن سابقه کم فشاری خون
    ناهنجاری رحمی
    کنترااندیکاسیون مصرف استروژن، پروژسترون و نیفیدیپین
    دریافت داروهای حاوی cytochrome P450 activity مانند azole antifungals, cimetidine, cyclosporine, erythromycin, quinidine, terfenadine, warfarin, benzodiazepines, flecainide, imipramine, propafenone and theophylline در بازه زمانی سه ماه قبل از ورود به مطالعه
    میزان هومورن محرک فولیکولFSH بیشتر از 20 میلی واحد بر میلی لیتر در روز 2-4 سیکل قاعدگی
    ضربان قلب نامنظم
    وجود سابقه‌ای از پرفشاری خون
    داشتن سابقه کم فشاری خون
    ناهنجاری رحمی
    کنترااندیکاسیون مصرف استروژن، پروژسترون و نیفیدیپین
    دریافت داروهای حاوی cytochrome P450 activity مانند azole antifungals, cimetidine, cyclosporine, erythromycin, quinidine, terfenadine, warfarin, benzodiazepines, flecainide, imipramine, propafenone and theophylline در بازه زمانی سه ماه قبل از ورود به مطالعه
    میزان هومورن محرک فولیکولFSH بیشتر از 20 میلی واحد بر میلی لیتر در روز 2-4 سیکل قاعدگی
    ضربان قلب نامنظم
    We will use the block randomization method by using: www.sealedenvelope.com
    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.
    تخصیص تصادفی نمونه ها با استفاده از روش بلاکی و با استفاده از سایت : www.sealedenvelope.com انجام خواهد شد.
    از تصادفی سازی بلوکها با توالی بلوکهای 6 تایی توسط کامپیوتر در هر بازو استفاده شد. از نسبت یک به یک برای اختصاص کیسها به هر بازو استفاده شد.
    Block randomization s conducted using :www.sealedenvelope.com and the randomization list was prepared by the statistician . In this triple blind randomization control trial, medicine are placed in similar packets and the sequence of medicine administration and the list of random allocation is not disclosed to dispensing practitioners. These packets are given to the dispensing nurse, who is unaware of the contents of each packet. When the doctor declares the eligibility of patients, the nurse give packets to them according to the identification numbering. Completion of the final information is up to the person who is unaware of the type of treatment and also the specialist will be blind.
    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.
    تصادفی سازی بلوکی با استفاده از: www.sealedenvelope.com انجام شد و لیست تصادفی سازی توسط متخصص آمار. تهیه شد.در این مطالعه کارازمایی بالینی تصادفی سه سو کور داروها در پاکت های مهر و موم شده قرار داده می شود که توسط پرستار بخش که از مطالعه خارج است نگهداری خواهند شد. رضایت اخلاق گرفته می شود. سپس پرستار بخش پاکت حاوی نوع دارو را در اختیار پزشک قرار می دهد و مداخله بر اساس دارو موجود در پاکت انجام میشود.تکمیل اطلاعات نهایی بر عهده فردی میباشد که از نوع درمان بی اطلاع است. همچنین متخصص امار نیز از نوع درمان کور خواهد بود
    لیست تصادفی سازی توسط متخصص آمار تهیه شد.در این روند داروهای کارازمایی بالینی در پاکت های مشابه قرار داده می شود. توالی داروهای تجویزی و لیست تصادفی تعیین شده برای پرسنل درمان آشکار نمی باشد. این پاکتها به پرستار مسوول که از محتوای آن آگاه نیست داده میشود. وقتی پزشک شایستگی بیمار برای دریافت دارو را تایید کرد پرستار پاکت را بر اساس شماره شناسایی تحویل میدهد. تکمیل اطلاعات نهایی بر عهده فردی میباشد که از نوع درمان بی اطلاع است.
  • Secondary outcomes

    #1
    empty
    Blood pressure Variation
    empty
    تغییرات فشار خون
    empty
    In three intervals including at the time of anesthesia induction, end of anesthesia, and in recovery time
    empty
    در سه بازه زمانی القای بیهوشی، پایان بیهوشی و زمان نقاهت
    empty
    With a pressure gauge
    empty
    با دستگاه فشار سنج
    #2
    empty
    Implantation rate
    empty
    میزان لانه گزینی
    empty
    In pregnancy
    empty
    در بارداری
    empty
    The implantation rates will calculated as the number of gestational sacs divided by the number of embryos transferred to the uterus
    empty
    میزان لانه گزینی به صورت تقسیم تعداد کیسه های حاملگی بر تعداد جنین های منتقل شده به رحم محاسبه خواهد شد.
    #3
    empty
    Multiple pregnancy rate
    empty
    میزان چند قلویی
    empty
    After pregnancy
    empty
    بعد از بارداری
    empty
    Ultrasonography
    empty
    سونوگرافی

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: 2022-11-19, 1401/08/28
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
empty
Actual recruitment end date
empty
Trial completion date
empty
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
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?
Yes
Title of funding source
Tehran 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
Tehran University of Medical Sciences
Full name of responsible person
Masoomeh Nataj Majd
Position
Assistant Professor
Latest degree
Medical doctor
Other areas of specialty/work
Anesthesiology
Street address
Arash Womens Hospital, Rashid Ave, Tehranpars, Resalat Highway
City
Tehran
Province
Tehran
Postal code
1653915981
Phone
+98 21 7771 9922
Fax
+98 21 7788 3196
Email
hosparash@tums.ac.ir

Person responsible for scientific inquiries

Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Masoomeh Nataj Majd
Position
Assistant Professor
Latest degree
Medical doctor
Other areas of specialty/work
Anesthesiology
Street address
Arash Womens Hospital, Rashid Ave, Tehranpars, Resalat Highway
City
Tehran
Province
Tehran
Postal code
1653915981
Phone
+98 21 7771 9922
Fax
+98 21 7788 3196
Email
hosparash@tums.ac.ir

Person responsible for updating data

Contact
Name of organization / entity
Arash Womens Hospital, Tehran Medical University
Full name of responsible person
Masoomeh Nataj Majd
Position
Assistant Professor
Latest degree
Medical doctor
Other areas of specialty/work
Anesthesiology
Street address
Arash Womens Hospital, Rashid Ave, Tehranpars, Resalat Highway
City
Tehran
Province
Tehran
Postal code
1653915981
Phone
+98 21 7771 9922
Fax
+98 21 7788 3196
Email
hosparash@tums.ac.ir

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
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