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Nifedipine Treatment on Uterine Contractility in IVF

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ClinicalTrials.gov Identifier: NCT02072291
Recruitment Status : Unknown
Verified February 2017 by Hadassah Medical Organization.
Recruitment status was:  Recruiting
First Posted : February 26, 2014
Last Update Posted : March 1, 2017
Sponsor:
Information provided by (Responsible Party):
Hadassah Medical Organization

Study Description
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Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Embryo Implantation Drug: Nifedipine Phase 2

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 90 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Care Provider)
Primary Purpose: Treatment
Official Title: The Influence of Nifedipine Treatment on Uterine Contractility During Frozen Embryo Transfer
Study Start Date : March 2014
Estimated Primary Completion Date : March 2018
Estimated Study Completion Date : June 2018

Resource links provided by the National Library of Medicine

Drug Information available for: Nifedipine

Arms and Interventions
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Arm Intervention/treatment
Experimental: Nifedipine
Nifedipine 5mg single dose
 Drug: Nifedipine
PO Nifedipine 5mg single dose
Placebo Comparator: Placebo Drug: Nifedipine
PO Nifedipine 5mg single dose


Outcome Measures
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Primary Outcome Measures :
  1. 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 Outcome Measures :
  1. Implantation and pregnancy rates [ Time Frame: 4 weeks ]
    Rates of implantation and clinical pregnancy (cardiac activity) after treatment against placebo


Eligibility Criteria
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Ages Eligible for Study:   18 Years to 45 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

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.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02072291


Contacts
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Contact: Assaf Ben-Meir, MD 972-2-6776425 assaf.benmeir@gmail.com

Locations
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Israel
Hadassah Medical Organization Recruiting
Jerusalem, Israel
Contact: Arik Tzukert, DMD    00 972 2 6776095    arik@hadassah.org.il   
Contact: Hadas Lemberg, PhD    00 972 2 6777572    lhadas@hadassah.org.il   
Principal Investigator: Assaf Ben-Meir, MD         
Sponsors and Collaborators
Hadassah Medical Organization
Investigators
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Principal Investigator: Assaf Ben-Meir, MD Hadassah Medical Center
More Information
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Responsible Party: Hadassah Medical Organization
ClinicalTrials.gov Identifier: NCT02072291    
Other Study ID Numbers: Nifedipine-FET
First Posted: February 26, 2014    Key Record Dates
Last Update Posted: March 1, 2017
Last Verified: February 2017
Additional relevant MeSH terms:
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Nifedipine
Calcium Channel Blockers
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Calcium-Regulating Hormones and Agents
 Physiological Effects of Drugs
Vasodilator Agents
Tocolytic Agents
Reproductive Control Agents