Clinical trial NCT02072291: Nifedipine Treatment on Uterine Contractility in IVF
Official title: The Influence of Nifedipine Treatment on Uterine Contractility During Frozen Embryo Transfer
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE2
Conditions: Embryo Implantation
Lead sponsor: Hadassah Medical Organization
Sponsor class: OTHER
First posted: 2014-02-26
Enrollment: 90
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: 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.

Primary outcomes:
measure: uterine contractility after treatment
timeFrame: 30 minutes after treatment
Secondary outcomes:
measure: Implantation and pregnancy rates
timeFrame: 4 weeks
Other outcomes:
Locations:
city: Jerusalem
country: Israel
facility: Hadassah Medical Organization
Study officials:
affiliation: Hadassah Medical Organization
name: Assaf Ben-Meir, MD
role: PRINCIPAL_INVESTIGATOR
References: