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RecruitingNCT03560583Updated Feb 10, 2025

Efficacy of Metoclopramide in Poor Ovarian Response IVF Patients

An interventional study of Metoclopramide and Placebo Oral Tablet in Poor Responders in IVF, sponsored by Barzilai Medical Center. Recruiting at 1 site in Israel. Open to female participants aged 18 Years to 54 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2025-02-10.

Sponsored by Barzilai Medical Center · Not applicable, Interventional, and Treatment

From the registry’s dates

  • Started May 2021; still recruiting 5 years 6 months later.
Phase
Not applicable
Study type
Interventional
Enrollment
60
Allocation
Randomized
Ages
18 Years to 54 Years
Sex
Female
01

Study 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.

02

Conditions studied

  • Poor Responders in IVF
03

In context

Lead sponsor

Barzilai Medical Center is the lead sponsor of 26 studies on the registry; 8 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 54 Years
Sexes eligible
Female
Accepts healthy volunteers
Yes

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • Poor response according to "Bologna criteria"

Exclusion criteria

Exclusion Criteria:

  • Allergy to metoclopramide
  • Prolactinemia
  • Women treated with dopamine agonists
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Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Double (Participant, Investigator)
Enrollment
60 participants (estimated)

Study arms

  • Experimental
    Metoclopramide 10 mg BID

    Drug: Metoclopramide

  • Placebo comparator
    Placebo 10 mg BID

    Drug: Placebo Oral Tablet

Interventions

  • DrugMetoclopramide

    Metoclopramide 10 mg BID

  • DrugPlacebo Oral Tablet

    Placebo 10 mg BID

06

What researchers measure

Primary outcomes

  1. Number of oocytes

    Number of oocytes

    Time frame: Approximately 5 weeks from first dose of study drug

07

Study locations

1 of 1 sites recruiting
08

References and documents

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. PubMed 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. PubMed 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. PubMed 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. PubMed 11396370 ↗
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Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reached

Started May 2021 (actual). Primary completion is estimated for Dec 2027, 79 months after the start.

How these figures are worked out, and which studies are left out of them.

Registered
Jun 7, 2018
First posted
Jun 18, 2018
StartActual
May 5, 2021
Primary completionEst.
Dec 2027
CompletionEst.
Jul 2028
Last update
Feb 10, 2025
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Feb 10, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT03560583
Lead sponsor
Barzilai Medical Center
Responsible party
Leon Grin (Gynecological Doctor, Barzilai Medical Center) — Principal investigator
First posted
Jun 18, 2018
Start date
May 5, 2021
Primary completion
Dec 2027 (estimated)
Completion
Jul 2028 (estimated)
Last update
Feb 10, 2025

Study contacts

Leon Grin, MD
Contact
leonti.grin@gmail.com
972-50-5999379
Leon Grin, MD
principal investigator · Barzilai Medical Center

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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Studies of the drug tested here: Metoclopramide

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Barzilai Medical Center

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