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Nifedipine Treatment on Uterine Contractility in IVF

Information source: Hadassah Medical Organization
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Embryo Implantation

Intervention: Nifedipine (Drug)

Phase: Phase 2

Status: Recruiting

Sponsored by: Hadassah Medical Organization

Official(s) and/or principal investigator(s):
Assaf Ben-Meir, MD, Principal Investigator, Affiliation: Hadassah Medical Center

Overall contact:
Assaf Ben-Meir, MD, Phone: 972-2-6776425, Email: assaf.benmeir@gmail.com

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.

Clinical Details

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

Study design: Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver), Primary Purpose: Treatment

Primary outcome: uterine contractility after treatment

Secondary outcome: Implantation and pregnancy rates

Eligibility

Minimum age: 18 Years. Maximum age: 45 Years. Gender(s): Female.

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.

Locations and Contacts

Assaf Ben-Meir, MD, Phone: 972-2-6776425, Email: assaf.benmeir@gmail.com

Hadassah Medical Organization, Jerusalem, Israel; Recruiting
Arik Tzukert, DMD, Phone: 00 972 2 6776095, Email: arik@hadassah.org.il
Hadas Lemberg, PhD, Phone: 00 972 2 6777572, Email: lhadas@hadassah.org.il
Assaf Ben-Meir, MD, Principal Investigator
Additional Information

Starting date: March 2014
Last updated: April 19, 2015

Page last updated: August 23, 2015

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