Nifedipine Treatment on Uterine Contractility in IVF

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE2

Total Enrollment

90 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-03-31

Study Completion Date

2018-06-30

Brief Summary

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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.

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Detailed Description

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Conditions

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Embryo Implantation

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Caregivers

Study Groups

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Nifedipine

Nifedipine 5mg single dose

Group Type EXPERIMENTAL

Nifedipine

Intervention Type DRUG

PO Nifedipine 5mg single dose

Placebo

Group Type PLACEBO_COMPARATOR

Nifedipine

Intervention Type DRUG

PO Nifedipine 5mg single dose

Interventions

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Nifedipine

PO Nifedipine 5mg single dose

Intervention Type DRUG

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Maximum Eligible Age

45 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No