Nifedipine Treatment on Uterine Contractility in IVF

Перакладаць артыкулы могуць толькі зарэгістраваныя карыстальнікі

Увайсці / Зарэгістравацца

Спасылка захоўваецца ў буферы абмену

Статус

Спонсары

Hadassah Medical Organization

КЛІНІЧНАЕ ВЫПРАБАВАННЕ: NCT02072291

BioSeek: NCT02072291

Ключавыя словы

Рэферат

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.

Даты

Апошняя праверка:	01/31/2017
Упершыню прадстаўлена:	02/23/2014
Меркаваная колькасць заявак прадстаўлена:	02/23/2014
Першае паведамленне:	02/25/2014
Апошняе абнаўленне адпраўлена:	02/27/2017
Апошняе абнаўленне апублікавана:	02/28/2017
Фактычная дата пачатку даследавання:	02/28/2014
Разліковая дата першаснага завяршэння:	02/28/2018
Разліковая дата завяршэння даследавання:	05/31/2018

Стан альбо хвароба

Embryo Implantation

Ўмяшанне / лячэнне

Drug: Nifedipine

Фаза

Фаза 2

Групы ўзбраенняў

Рука	Ўмяшанне / лячэнне
Experimental: Nifedipine Nifedipine 5mg single dose
Placebo Comparator: Placebo

Крытэрыі прыдатнасці

Узрост, які мае права на вучобу	18 Years Каб 18 Years
Пол, прыдатны для навучання	Female
Прымае здаровых валанцёраў	Так
Крытэрыі	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.

Вынік

Першасныя вынікі

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

Меры другаснага выніку

1. Implantation and pregnancy rates [4 weeks]

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