Nifedipine Treatment on Uterine Contractility in IVF

Overview

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.

Full Title of Study: “The Influence of Nifedipine Treatment on Uterine Contractility During Frozen Embryo Transfer”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Treatment
    • Masking: Double (Participant, Care Provider)
  • Study Primary Completion Date: March 2018

Interventions

  • Drug: Nifedipine
    • PO Nifedipine 5mg single dose

Arms, Groups and Cohorts

  • Experimental: Nifedipine
    • Nifedipine 5mg single dose
  • Placebo Comparator: Placebo

Clinical Trial Outcome Measures

Primary Measures

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

Secondary Measures

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

Participating in This Clinical Trial

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.

Gender Eligibility: Female

Minimum Age: 18 Years

Maximum Age: 45 Years

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Hadassah Medical Organization
  • Provider of Information About this Clinical Study
    • Sponsor
  • Overall Official(s)
    • Assaf Ben-Meir, MD, Principal Investigator, Hadassah Medical Organization
  • Overall Contact(s)
    • Assaf Ben-Meir, MD, 972-2-6776425, assaf.benmeir@gmail.com

Clinical trials entries are delivered from the US National Institutes of Health and are not reviewed separately by this site. Please see the identifier information above for retrieving further details from the government database.

At TrialBulletin.com, we keep tabs on over 200,000 clinical trials in the US and abroad, using medical data supplied directly by the US National Institutes of Health. Please see the About and Contact page for details.