Nifedipine Treatment on Uterine Contractility in IVF

Hadassah Medical Center

Status and phase

Unknown

Phase 2

Conditions

Embryo Implantation

Treatments

Drug: Nifedipine

Study type

Interventional

Funder types

Other

Identifiers

NCT02072291

Nifedipine-FET

Details and patient eligibility

About

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.

Enrollment

90 estimated patients

Sex

Female

Ages

18 to 45 years old

Volunteers

No Healthy Volunteers

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.