The aim of this study is to determine the effect of nifedipine administration before embryo transfer on pregnancy rate of patients undergoing IVF.
Design
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
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. 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.
Participants/Inclusion and exclusion criteria
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
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
Acronym
IRCT registration information
IRCT registration number:IRCT20140111016162N3
Registration date:2020-06-26, 1399/04/06
Registration timing:registered_while_recruiting
Last update:2020-06-26, 1399/04/06
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
Being in class A
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
Investigator
Outcome assessor
Data analyser
Sample size
Target sample size:
158
Randomization (investigator's opinion)
Randomized
Randomization description
We will use the block randomization method by using: www.sealedenvelope.com
Blinding (investigator's opinion)
Single blinded
Blinding description
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.
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 St, Keshavarz Blvd
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
empty
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 Ave, Resalat Highway, Tehranparse,Tehran, Iran
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 St, Keshavarz Blvd
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?