Efficacy of Metoclopramide in Poor Ovarian Response IVF Patients

• Sponsor: Barzilai Medical Center (Other)
• Overall Status: Unknown status
• CT.gov ID: NCT03560583
• Collaborator: (none)
• Enrollment: 60
• Arms: 2
• Anticipated Duration (Months): 12

Study Details

Study Description

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	N/A

Study Design

• Study Type: Interventional
• Anticipated 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
• Anticipated Study Start Date: Jul 1, 2021
• Anticipated Primary Completion Date: Jul 1, 2022
• Anticipated Study Completion Date: Jul 1, 2022

Arms and Interventions

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

Primary Outcome Measures

1. Number of oocytes [Approximately 5 weeks from first dose of study drug]

   Number of oocytes

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 54 Years
• Sexes Eligible for Study: Female
• Accepts Healthy Volunteers: Yes

Inclusion Criteria:

• Poor response according to "Bologna criteria"

Exclusion Criteria:

• Allergy to metoclopramide

• Prolactinemia

• Women treated with dopamine agonists

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

• Barzilai Medical Center

Investigators

• Principal Investigator: Leon Grin, MD, Barzilai Medical Center

Study Documents (Full-Text)

None provided.

More Information

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. Review.
• Hernández I, Parra A, Méndez I, Cabrera V, Cravioto MC, Mercado M, Díaz-Sánchez 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.
• Mendes MC, Ferriani RA, Sala MM, Moura MD, Carrara HH, de Sá MF. Effect of transitory hyperprolactinemia on in vitro fertilization of human oocytes. J Reprod Med. 2001 May;46(5):444-50.
• Prelević GM, Würzburger MI, Perić LA. Metoclopramide effect on serum prolactin LH and FSH in patients with polycystic ovary syndrome. J Endocrinol Invest. 1988 Apr;11(4):255-9.

• Responsible Party: Leon Grin, Gynecological Doctor, Barzilai Medical Center
• ClinicalTrials.gov Identifier: NCT03560583
• Other Study ID Numbers: BRZ 0046-17 CTIL
• First Posted: Jun 18, 2018
• Last Update Posted: Jul 9, 2020
• Last Verified: Jul 1, 2020

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Additional relevant MeSH terms: Metoclopramide

Study Results

No Results Posted as of Jul 9, 2020