None listed
Conditions
Brief summary
Implantation failure is the main factor affecting the success rate of IVF procedures. Excessive uterine contractions have been described as a potential reason for reduced implantation rates in IVF cycles. Contractile activity of the uterus could move the implanted embryo towards the Fallopian tubes or cervix/vagina or the embryo might even be expelled out of the uterus. Mechanical measures to reduce the uterine contractions at the time of embryo transfer include using a soft catheter without touching the fundus (the top of the uterus) and the use of ultrasound to guide embryo transfer. Various medications have been investigated to reduce uterine contractions, including cyclo-oxygenase inhibitors, B2-adrenoreceptor agonists, phosphodiesterase inhibitors. These have yielded variable results with atosiban, an oxytocin/vasopressin receptor antagonist, looking most promising for improving implantation and pregnancy rates. Calcium channel blockers are non-specific smooth muscle relaxants, used for the treatment of high blood pressure in adults and have an established role in preterm labour due to its uterine relaxing properties. In the uterus, the calcium channel blockers exert their “anti-contraction” effect by preventing the influx of extracellular calcium ions into the myometrial cell (the middle wall of the uterus) and have been demonstrated in laboratory experiments to have potent relaxant effect on human myometrium (the middle wall of the uterus). The most widely used and studied calcium channel blocker is nifedipine and there is evidence that this can be safely used in pregnancy. The objective of this study is to evaluate the effectiveness of nifedipine administration in improving implantation and pregnancy rates in IVF/ICSI fresh or frozen embryo transfers.
Interventions
Nifedipine (20mg oral tablet, immediate release preparation) administered once only 30 minutes prior to embryo transfer
Sponsors
Melbourne IVF
Study design
Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Treatment
Masking
Blinded (masking used) (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
All
Age
18 Years to 45 Years
Healthy volunteers
Yes
Inclusion criteria
* 18-45yo females undergoing IVF/ICSI cycles with either fresh or frozen embryo transfer. * Baseline Blood Pressure: greater than, or equal to, 100/60, measured prior to ET
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 being treated 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. *BP <100/60
Outcome results
None listed