NCT02072291

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
90

participants targeted

Target at P50-P75 for phase_2

Timeline
Completed

Started Mar 2014

Typical duration for phase_2

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

February 24, 2014

Completed
2 days until next milestone

First Posted

Study publicly available on registry

February 26, 2014

Completed
3 days until next milestone

Study Start

First participant enrolled

March 1, 2014

Completed
4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2018

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2018

Completed
Last Updated

March 1, 2017

Status Verified

February 1, 2017

Enrollment Period

4 years

First QC Date

February 24, 2014

Last Update Submit

February 28, 2017

Conditions

Embryo Implantation

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (1)

  • Implantation and pregnancy rates

    4 weeks

Study Arms (2)

Nifedipine

EXPERIMENTAL

Nifedipine 5mg single dose

Drug: Nifedipine

Placebo

PLACEBO COMPARATOR
Drug: Nifedipine

Interventions

NifedipineDRUG

PO Nifedipine 5mg single dose

NifedipinePlacebo

Eligibility Criteria

Age18 Years - 45 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • Patient undergoing frozen embryo transfer

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hadassah Medical Organization

Jerusalem, Israel

RECRUITING

MeSH Terms

Interventions

Nifedipine

Intervention Hierarchy (Ancestors)

DihydropyridinesPyridinesHeterocyclic Compounds, 1-RingHeterocyclic Compounds

Study Officials

  • Assaf Ben-Meir, MD

    Hadassah Medical Organization

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Assaf Ben-Meir, MD

CONTACT

972-2-6776425assaf.benmeir@gmail.com

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, CARE PROVIDER
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 24, 2014

First Posted

February 26, 2014

Study Start

March 1, 2014

Primary Completion

March 1, 2018

Study Completion

June 1, 2018

Last Updated

March 1, 2017

Record last verified: 2017-02

Locations

IL(1)