Cabergoline Before or After Oocyte Collection for Follicular Resolution

Study Overview
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Brief Summary
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Randomized trial comparing the efficacy of two different times of administration of cabergoline in patients undergoing controlled ovarian stimulation and oocyte collection.

Official Title
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Cabergoline Before or After Oocyte Collection for Follicular Resolution

Conditions
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Infertility, Female

Intervention / Treatment
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* Drug: Cabergoline Pill


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Adult female at least 18 years of age intending to undergo ovarian stimulation for a cycle of IVF. Ability read and understand English sufficiently to obtain informed consent and complete a study diary. Pre-implantation genetic screening (PGS) is allowed. Egg donors are allowed. Patients using a gestational carrier are allowed. Patients with prior IVF cycles are allowed, but no patient can undergo more than one cycle with oocyte collection under this study. Exclusion Criteria: Egg banking, donor egg banking, or any cycle type that would preclude immediate culture to blastocyst stage. Patients that would be unavailable for the follow-up ultrasound 5 days post-retrieval, such as patients that live far from the clinic (e.g. out of state). Uncontrolled hypertension. Ergot alkaloid hypersensitivity or allergy. History of pulmonary, pericardial, retroperitoneal fibrotic disorders. History of bipolar disorder, schizophrenia, or psychotic illness. Breast feeding. History of eclampsia or pre-eclampsia. Severe hepatic dysfunction. Current use of any dopamine receptor agonist or antagonist for any purpose, including, but not limited to, cabergoline (Dostinex), aripiprazole (Abilify), bromocriptine (Parlodel), methylphenidate (Ritalin), buproprion (Wellbutrin, Zyban), lisdexamfetamine (Vyvanse). Any condition that, in the opinion of the physician or principal investigator, would place the patient at undue risk under this protocol or would otherwise make the protocol inappropriate for that subject.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Early administration<br>Cabergoline administered the day before egg collection. | Drug: Cabergoline Pill<br>* 0.5 mg cabergoline pill taken orally<br>|
| Experimental: Late administration<br>Cabergoline administered after egg collection. | Drug: Cabergoline Pill<br>* 0.5 mg cabergoline pill taken orally<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Discomfort level | Self-assessed discomfort level | 5 days after egg collection | 
| Mature oocyte rate per follicular puncture | Ratio of mature oocytes obtained to punctured ovarian follicles | Within 24 hours of egg collection | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Ovarian volume |  | 5 days post retrieval | 
| oocyte count |  | Within 24 hours of egg collection | 
| Oocyte to follicle ratio |  | Within 24 hours of egg collection | 
| M1 oocyte rate |  | Within 24 hours of egg collection | 
| M1 to M2 oocyte ratio |  | Within 24 hours of egg collection | 
| Aneuploidy rate | Genetic test results of embryos for patients who opt for such testing. | Within 14 days of egg collection |