Assessment of Nifedipine administration before fetus transfering in IVF on the rate of pregnancy in infertile women

Determine the effect of nifedipine administration before embryo transfer on pregnancy rate of patients undergoing IVF.

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.

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.

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 group: intake of oral nifedipine tablets, 20 Mg, 30 minutes before embryo transfer. Control group: No intervention

Clinical pregnancy; chemical pregnancy

Mismatch between IRCT and article due to blindness and randomization, inclusion and exclusion criteria, secondary results and correction of ethic code.

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.

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.