The Influence of Nifedipine Treatment on Uterine Contractility During Frozen Embryo Transfer
试验速览
- 阶段
- 2 期
- 入组人数
- 90
- 试验地点
- 1
- 主要终点
- uterine contractility after treatment
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Care Provider)
入排标准
- 年龄范围
- 18 Years 至 45 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Patient undergoing frozen embryo transfer
排除标准
- •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.
研究组 & 干预措施
Nifedipine
Nifedipine 5mg single dose
干预措施: Nifedipine (Drug)
Placebo
干预措施: Nifedipine (Drug)
结局指标
主要结局
uterine contractility after treatment
时间窗: 30 minutes after treatment
Uterine contractility will be measured by vaginal ultrasound before and 30 minutes after treatment with Nifedipine or placebo
次要结局
- Implantation and pregnancy rates(4 weeks)