Efficacy of Metoclopramide in Poor Ovarian Response IVF Patients

NCT ID: NCT03560583

Last Updated: 2025-02-10

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

RECRUITING

Clinical Phase

NA

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-05-05

Study Completion Date

2028-07-31

Brief Summary

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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.

Detailed Description

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Conditions

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Poor Responders in IVF

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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Metoclopramide 10 mg BID

Group Type EXPERIMENTAL

Metoclopramide

Intervention Type DRUG

Metoclopramide 10 mg BID

Placebo 10 mg BID

Group Type PLACEBO_COMPARATOR

Placebo Oral Tablet

Intervention Type DRUG

Placebo 10 mg BID

Interventions

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Metoclopramide

Metoclopramide 10 mg BID

Intervention Type DRUG

Placebo Oral Tablet

Placebo 10 mg BID

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Poor response according to "Bologna criteria"

Exclusion Criteria

* Allergy to metoclopramide
* Prolactinemia
* Women treated with dopamine agonists
Minimum Eligible Age

18 Years

Maximum Eligible Age

54 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes

Sponsors

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Barzilai Medical Center

OTHER

Sponsor Role lead

Responsible Party

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Leon Grin

Gynecological Doctor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Leon Grin, MD

Role: PRINCIPAL_INVESTIGATOR

Barzilai Medical Center

Locations

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Barzilai University Medical Center

Ashkelon, Ashkelon District, Israel

Site Status RECRUITING

Countries

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Israel

Central Contacts

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Leon Grin, MD

Role: CONTACT

972-50-5999379

Facility Contacts

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Dr Leonty Green, MD

Role: primary

+972-50-5999379

Dr Arie Budovsky, PhD

Role: backup

References

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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.

Reference Type BACKGROUND
PMID: 28614956 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 10880731 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 3137253 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 11396370 (View on PubMed)

Other Identifiers

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BRZ 0046-17 CTIL

Identifier Type: -

Identifier Source: org_study_id

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