Nifedipine Treatment on Uterine Contractility in IVF

Phase 2

• Conditions: Embryo Implantation
• Interventions: Drug: Nifedipine

• Registration Number: NCT02072291
• Lead Sponsor: Hadassah Medical Organization

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2014-02-24
• Study First Submitted QC: 2014-02-24
• Study First Posted: 2014-02-26
• Study Start: 2014-03
• Status Verified: 2017-02
• Last Update Submitted: 2017-02-28
• Last Update Posted: 2017-03-01
• Primary Completion: 2018-03
• Study Completion: 2018-06

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: Female
• Target Recruitment: 90

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Nifedipine	Nifedipine	Nifedipine 5mg single dose
Placebo	Nifedipine	-

Primary Outcome Measures

Name	Time	Method
uterine contractility after treatment	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

Name	Time	Method
Implantation and pregnancy rates	4 weeks	Rates of implantation and clinical pregnancy (cardiac activity) after treatment against placebo

Trial Locations

Locations (1)

Hadassah Medical Organization; 🇮🇱 Jerusalem, Israel