Nifedipine Treatment on Uterine Contractility in IVF

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Estati

Patwone

Hadassah Medical Organization

ESÈ KLINIK: NCT02072291

BioSeek: NCT02072291

Mo kle

Abstrè

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.

Dat

Dènye verifye:	01/31/2017
Premye Soumèt:	02/23/2014
Enskripsyon Estimasyon Soumèt:	02/23/2014
Premye afiche:	02/25/2014
Dènye Mizajou Soumèt:	02/27/2017
Dènye Mizajou afiche:	02/28/2017
Dat aktyèl kòmanse etid la:	02/28/2014
Dat Estimasyon Prensipal Estimasyon an:	02/28/2018
Dat estime fini etid la:	05/31/2018

Kondisyon oswa maladi

Embryo Implantation

Entèvansyon / tretman

Drug: Nifedipine

Faz

Faz 2

Gwoup bra

Bra	Entèvansyon / tretman
Experimental: Nifedipine Nifedipine 5mg single dose
Placebo Comparator: Placebo

Kritè kalifikasyon yo

Laj ki kalifye pou etid	18 Years Pou 18 Years
Sèks ki kalifye pou etid	Female
Aksepte Volontè Healthy	Wi
Kritè	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.

Rezilta

Mezi Rezilta Prensipal yo

1. 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

Mezi Rezilta Segondè

1. Implantation and pregnancy rates [4 weeks]

Rates of implantation and clinical pregnancy (cardiac activity) after treatment against placebo

Nifedipine Treatment on Uterine Contractility in IVF

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phosphodiesterase

oxygenase

dental caries