Efficacy of Metoclopramide in Poor Ovarian Response IVF Patients
1 other identifier
interventional
60
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started May 2021
Longer than P75 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
June 7, 2018
CompletedFirst Posted
Study publicly available on registry
June 18, 2018
CompletedStudy Start
First participant enrolled
May 5, 2021
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2027
ExpectedStudy Completion
Last participant's last visit for all outcomes
July 1, 2028
February 10, 2025
February 1, 2025
6.6 years
June 7, 2018
February 6, 2025
Conditions
Outcome Measures
Primary Outcomes (1)
Number of oocytes
Number of oocytes
Approximately 5 weeks from first dose of study drug
Study Arms (2)
Metoclopramide 10 mg BID
EXPERIMENTALPlacebo 10 mg BID
PLACEBO COMPARATORInterventions
Eligibility Criteria
You may qualify if:
- Poor response according to "Bologna criteria"
You may not qualify if:
- Allergy to metoclopramide
- Prolactinemia
- Women treated with dopamine agonists
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Barzilai University Medical Center
Ashkelon, Ashkelon District, 7830604, Israel
Related Publications (4)
Boelig RC, Barton SJ, Saccone G, Kelly AJ, Edwards SJ, Berghella V. Interventions for treating hyperemesis gravidarum: a Cochrane systematic review and meta-analysis. J Matern Fetal Neonatal Med. 2018 Sep;31(18):2492-2505. doi: 10.1080/14767058.2017.1342805. Epub 2017 Jul 11.
PMID: 28614956BACKGROUNDHernandez I, Parra A, Mendez I, Cabrera V, Cravioto MC, Mercado M, Diaz-Sanchez V, Larrea F. Hypothalamic dopaminergic tone and prolactin bioactivity in women with polycystic ovary syndrome. Arch Med Res. 2000 Mar-Apr;31(2):216-22. doi: 10.1016/s0188-4409(00)00059-x.
PMID: 10880731BACKGROUNDPrelevic GM, Wurzburger MI, Peric LA. Metoclopramide effect on serum prolactin LH and FSH in patients with polycystic ovary syndrome. J Endocrinol Invest. 1988 Apr;11(4):255-9. doi: 10.1007/BF03350148.
PMID: 3137253BACKGROUNDMendes MC, Ferriani RA, Sala MM, Moura MD, Carrara HH, de Sa MF. Effect of transitory hyperprolactinemia on in vitro fertilization of human oocytes. J Reprod Med. 2001 May;46(5):444-50.
PMID: 11396370BACKGROUND
MeSH Terms
Interventions
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Leon Grin, MD
Barzilai Medical Center
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Gynecological Doctor
Study Record Dates
First Submitted
June 7, 2018
First Posted
June 18, 2018
Study Start
May 5, 2021
Primary Completion (Estimated)
December 1, 2027
Study Completion (Estimated)
July 1, 2028
Last Updated
February 10, 2025
Record last verified: 2025-02