Dopamine D-2 Antagonist Use in Poor Responders in IVF: a Randomized Controlled Trial (NCT02262923) | Clinical Trial Compass
WithdrawnNot Applicable
Dopamine D-2 Antagonist Use in Poor Responders in IVF: a Randomized Controlled Trial
Canada0Started 2016-03
Plain-language 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.
Who can participate
Age range
21 Years – 43 Years
Sex
FEMALE
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.