Dopamine D-2 Antagonist Use in Poor Responders in IVF: a Randomized Controlled Trial

• Status: Unknown status
• Trial end date: 2018-03-01
• Target enrollment: 0
• Participant gender: Female

Summary

Metoclopramide is a dopamine D2 receptor antagonist with antiemetic and gastrokinetic properties which has been approved for use in pregnant women. Women with polycystic ovary syndrome (PCOS) have been found to have lower dopaminergic tone and increased ovarian vascularity and vascular endothelial growth factor (VEGF) levels compared to controls. During ovarian stimulation, PCOS patients exhibit greater sensitivity to gonadotropins and increased follicular development. Administration of dopamine D2 antagonists may mimic the low dopaminergic tone noted in PCOS patients, increase VEGF levels, angiogenesis, and subsequently improve follicular growth during ovarian stimulation. This strategy could be used to improve IVF outcomes in poor responders.

The investigators hypothesize that, compared to gonadotropin use alone, the use of metoclopramide in combination with gonadotropins in poor responders undergoing IVF will result in an increased number of mature oocytes obtained at oocyte retrieval and improved IVF outcomes.

• Phase: N/A
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Mount Sinai Hospital, Canada
• Treatments: Dopamine; Dopamine D2 Receptor Antagonists; Metoclopramide

Criteria

Inclusion Criteria:

• Poor responders undergoing a repeat IVF cycle defined as women who have undergone at least one previous IVF cycle with fewer than 4 oocytes retrieved and at least one of the following:

• Advanced age (≥40 years) or any other risk factor for poor ovarian response

• Abnormal ovarian reserve testing (antral follicle count (AFC) < 5-7 or anti-mullerian hormone (AMH) level < 3.6-7.9 pmol/L)

Exclusion Criteria:

• Subjects who have previously been recruited into this study and either had cycle cancellation, underwent retrieval or dropped out of the study.

• Women with contraindications or allergies to metoclopramide.

• Women with elevated prolactin levels or known to have pituitary microadenomas or macroadenoma.

• Women who are taking dopamine agonist medications.