Nifedipine Treatment on Uterine Contractility in IVF

Embryo Implantation Clinical Trial

Official title:

The Influence of Nifedipine Treatment on Uterine Contractility During Frozen Embryo Transfer

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02072291
• Other study ID #: Nifedipine-FET
• Status: Recruiting
• Phase: Phase 2
• First received: February 24, 2014
• Last updated: February 28, 2017
• Start date: March 2014
• Est. completion date: June 2018

Study information

• Verified date: February 2017
• Source: Hadassah Medical Organization
• Contact: Assaf Ben-Meir, MD
• Phone: 972-2-6776425
• Email: assaf.benmeir[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 90
• Est. completion date: June 2018
• Est. primary completion date: March 2018
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 45 Years

Eligibility

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.

Related Conditions & MeSH terms

• Embryo Implantation

Intervention

Drug:
• Nifedipine
PO Nifedipine 5mg single dose

Locations

Country	Name	City	State
Israel	Hadassah Medical Organization	Jerusalem

Sponsors (1)

Lead Sponsor	Collaborator
Hadassah Medical Organization

Country where clinical trial is conducted

Israel, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	uterine contractility after treatment	Uterine contractility will be measured by vaginal ultrasound before and 30 minutes after treatment with Nifedipine or placebo	30 minutes after treatment
Secondary	Implantation and pregnancy rates	Rates of implantation and clinical pregnancy (cardiac activity) after treatment against placebo	4 weeks