Efficacy of Metoclopramide in Poor Ovarian Response IVF Patients
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Metoclopramide, Placebo Oral Tablet.
- Who it may be relevant to
- Registry conditions: Poor Responders in IVF. Basic parameters: 18 years — 54 years · Female.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Israel
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Efficacy of Metoclopramide in Poor Ovarian Response IVF Patients: a Randomised, Double-blind, Placebo-controlled Trial
Overview
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.
Interventions
- Drug Metoclopramide
Metoclopramide 10 mg BID - Drug Placebo Oral Tablet
Placebo 10 mg BID
Primary outcome measures
- Number of oocytes [Time frame: Approximately 5 weeks from first dose of study drug]
Eligibility criteria
Inclusion criteria
- Poor response according to "Bologna criteria"
Exclusion criteria
- Allergy to metoclopramide
- Prolactinemia
- Women treated with dopamine agonists
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: Yes
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Double blind
- Primary purpose
- Treatment
Study locations
Israel · 1 center
- Barzilai University Medical Center — Ashkelon
Publications
- 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 28614956
- Hernandez 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 10880731
- Prelevic 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 3137253
- Mendes 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 11396370
Identifiers
NCT: NCT03560583 · BRZ 0046-17 CTIL