Nifedipine Treatment on Uterine Contractility in IVF | NCT02072291

Studies
Nifedipine Treatment on Uterine Contractility in IVF

NCT02072291

Sponsor

Hadassah Medical Organization

Status

Unknown status

Last Update Posted

Mar 1, 2017Actual

Enrollment

90Estimated

Phase

Phase 2

Conditions

Embryo Implantation

Interventions

Nifedipine

Countries

Israel

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Feb 2017

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Mar 2014

Primary Completion Date

Mar 2018Estimated

Completion Date

Jun 2018Estimated

First Submitted Date

Feb 24, 2014

First Submission Date that Met QC Criteria

Feb 24, 2014

First Posted Date

Feb 26, 2014Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Feb 28, 2017

Last Update Posted Date

Mar 1, 2017Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 2

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

90Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Nifedipine	Experimental	Nifedipine 5mg single dose	Drug: Nifedipine
Placebo	Placebo Comparator		Drug: Nifedipine

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Nifedipine	Drug	PO Nifedipine 5mg single dose	Nifedipine Placebo

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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

Measure	Description	Time Frame
Implantation and pregnancy rates	Rates of implantation and clinical pregnancy (cardiac activity) after treatment against placebo	4 weeks

Other Outcomes

Not provided

Eligibility Module

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.

Accepts Healthy Volunteers

Sex

Female

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

45 Years

Standard Ages

Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Assaf Ben-Meir, MD	Contact	972-2-6776425		assaf.benmeir@gmail.com

Overall Officials

Name	Affiliation	Role
Assaf Ben-Meir, MD	Hadassah Medical Organization	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Hadassah Medical Organization	Recruiting	Jerusalem			Israel

ID	Term
D004095	Dihydropyridines
D011725	Pyridines
D006573	Heterocyclic Compounds, 1-Ring
D006571	Heterocyclic Compounds