Nifedipine Treatment on Uterine Contractility in IVF

The Influence of Nifedipine Treatment on Uterine Contractility During Frozen Embryo Transfer

The main factors associated with pregnancy rate in In Vitro Fertilization (IVF) treatment are embryo quality and the uterine ability to accept the embryo for implantation. This ability is influenced by uterine contractions (UC), which change in pattern and direction during the menstrual cycle. An abnormal uterine contraction pattern can displace the embryo from the proper position in the uterine cavity towards the cervix or the fallopian tubes and as a result may decrease pregnancy rates and increase the risk of ectopic pregnancy. Indeed, previous studies demonstrated a negative correlation between uterine contraction rate and implantation/pregnancy rates. Suppression of uterine contractions during embryo transfer can be achieved by a large array of drugs, such as cyclo-oxygenase inhibitors, β2-adrenoreceptor agonists, calcium-channel blockers, phosphodiesterase inhibitors and oxytocin antagonists. The objective of this study is to evaluate the efficacy of Nifedipine administration in reducing uterine contractility during IVF-frozen embryo transfer (FET) treatment.

Study Overview

• Status: Unknown
• Conditions: Embryo Implantation
• Intervention / Treatment: Drug: Nifedipine

• Study Type: Interventional
• Enrollment (Anticipated): 90
• Phase: Phase 2

Contacts and Locations

Study Locations

• Israel
  • Jerusalem, Israel
    • Recruiting
    • Hadassah Medical Organization

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 45 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

Inclusion Criteria:

• Patient undergoing frozen embryo transfer

Exclusion Criteria:

• Body mass index (BMI) > 38 kg/m2
• Early follicular phase (day 2-4) serum follicle stimulating hormone (FSH) level > 20 mIU/ml.
• Abnormal uterine cavity as evidenced by sonohysterogram or hysterosalpingography
• Any contraindication to being pregnant and carrying a pregnancy to term.
• Contraindication for the use of nifedipine, Estrogen and Progesterone suppositories.
• Patient treating with other drugs that interact with cytochrome P450 activity: azole antifungals, cimetidine, cyclosporine, erythromycin, quinidine, terfenadine, warfarin, benzodiazepines, flecainide, imipramine, propafenone and theophylline.
• Irregular heart beat or already being treated with another medication for high blood pressure.
• Any ovarian or abdominal abnormality that may interfere with adequate transvaginal sonography (TVS) evaluation.
• Administration of any investigational drugs within three months prior to study enrollment.
• Patient not able to communicate adequately with the investigators and to comply with the requirements of the entire study.
• Unwillingness to give written informed consent. Previous entry into this study or simultaneous participation in another clinical trial.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: Placebo	Drug: Nifedipine; PO Nifedipine 5mg single dose
Experimental: Nifedipine; Nifedipine 5mg single dose	Drug: Nifedipine; PO Nifedipine 5mg single dose

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
uterine contractility after treatment	Uterine contractility will be measured by vaginal ultrasound before and 30 minutes after treatment with Nifedipine or placebo	30 minutes after treatment

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Implantation and pregnancy rates	Rates of implantation and clinical pregnancy (cardiac activity) after treatment against placebo	4 weeks

Collaborators and Investigators

• Sponsor: Hadassah Medical Organization
• Investigators: Principal Investigator: Assaf Ben-Meir, MD, Hadassah Medical Organization

Study record dates

Study Major Dates

• Study Start: March 1, 2014
• Primary Completion (Anticipated): March 1, 2018
• Study Completion (Anticipated): June 1, 2018

Study Registration Dates

• First Submitted: February 24, 2014
• First Submitted That Met QC Criteria: February 24, 2014
• First Posted (Estimate): February 26, 2014

Study Record Updates

• Last Update Posted (Actual): March 1, 2017
• Last Update Submitted That Met QC Criteria: February 28, 2017
• Last Verified: February 1, 2017

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Vasodilator Agents; Membrane Transport Modulators; Calcium-Regulating Hormones and Agents; Reproductive Control Agents; Calcium Channel Blockers; Tocolytic Agents; Nifedipine
• Other Study ID Numbers: Nifedipine-FET

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No