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Efficacy of Metoclopramide in Poor Ovarian Response IVF Patients

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ClinicalTrials.gov Identifier: NCT03560583
Recruitment Status : Not yet recruiting
First Posted : June 18, 2018
Last Update Posted : July 9, 2020
Sponsor:
Information provided by (Responsible Party):
Leon Grin, Barzilai Medical Center

Study Description
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Brief Summary:

Poor ovarian response population of ART are considered the biggest challenge for providers. Hitherto, no one protocol has been proven to be effect in this subgroup of IVF patients.

Metoclopramide belongs to the antiemetic group, used for motion sickness and during early gestation for hyperemesis gravidarum.

The mechanism of action is antagonisim to dopamine receptors. We hypothesize than by blocking dopamine receptors and decreasing the dopaminergic tone there is a possibility to increase the sensitivity of ovarian response to gonadotropins during controlled ovarian stimulation and result in increased oocyte retrival.


Condition or disease Intervention/treatment Phase
Poor Responders in IVF Drug: Metoclopramide Drug: Placebo Oral Tablet Not Applicable

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 60 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: Efficacy of Metoclopramide in Poor Ovarian Response IVF Patients: a Randomised, Double-blind, Placebo-controlled Trial
Estimated Study Start Date : July 2021
Estimated Primary Completion Date : July 2022
Estimated Study Completion Date : July 2022

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Experimental: Metoclopramide 10 mg BID Drug: Metoclopramide
Metoclopramide 10 mg BID
Placebo Comparator: Placebo 10 mg BID Drug: Placebo Oral Tablet
Placebo 10 mg BID


Outcome Measures
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Primary Outcome Measures :
  1. Number of oocytes [ Time Frame: Approximately 5 weeks from first dose of study drug ]
    Number of oocytes


Eligibility Criteria
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Ages Eligible for Study:   18 Years to 54 Years   (Adult)
Sexes Eligible for Study:   Female
Gender Based Eligibility:   Yes
Gender Eligibility Description:   Females
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Poor response according to "Bologna criteria"

Exclusion Criteria:

  • Allergy to metoclopramide
  • Prolactinemia
  • Women treated with dopamine agonists
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03560583


Contacts
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Contact: Leon Grin, MD 972-50-5999379 leonti.grin@gmail.com

Sponsors and Collaborators
Barzilai Medical Center
Investigators
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Principal Investigator: Leon Grin, MD Barzilai Medical Center
More Information
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Publications:

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Responsible Party: Leon Grin, Gynecological Doctor, Barzilai Medical Center
ClinicalTrials.gov Identifier: NCT03560583    
Other Study ID Numbers: BRZ 0046-17 CTIL
First Posted: June 18, 2018    Key Record Dates
Last Update Posted: July 9, 2020
Last Verified: July 2020

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Metoclopramide
Antiemetics
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Gastrointestinal Agents
 Dopamine D2 Receptor Antagonists
Dopamine Antagonists
Dopamine Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action