Cabergoline Before or After Oocyte Collection for Follicular Resolution

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

Study Overview

• Status: Completed
• Conditions: Infertility, Female
• Intervention / Treatment: Drug: Cabergoline Pill

• Study Type: Interventional
• Enrollment (Actual): 70
• Phase: Phase 4

Contacts and Locations

Study Locations

• United States
  • Nevada
    • Las Vegas, Nevada, United States, 89117
      • Fertility Center of Las Vegas

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

Inclusion Criteria:

1. Adult female at least 18 years of age intending to undergo ovarian stimulation for a cycle of IVF.
2. Ability read and understand English sufficiently to obtain informed consent and complete a study diary.
3. Pre-implantation genetic screening (PGS) is allowed.
4. Egg donors are allowed.
5. Patients using a gestational carrier are allowed.
6. Patients with prior IVF cycles are allowed, but no patient can undergo more than one cycle with oocyte collection under this study.

Exclusion Criteria:

1. Egg banking, donor egg banking, or any cycle type that would preclude immediate culture to blastocyst stage.
2. 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).
3. Uncontrolled hypertension.
4. Ergot alkaloid hypersensitivity or allergy.
5. History of pulmonary, pericardial, retroperitoneal fibrotic disorders.
6. History of bipolar disorder, schizophrenia, or psychotic illness.
7. Breast feeding.
8. History of eclampsia or pre-eclampsia.
9. Severe hepatic dysfunction.
10. 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).
11. 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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

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

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Fertility Center of Las Vegas
• Investigators: Principal Investigator: Bruce Shapiro, MD, Fertility Center of Las Vehas

Study record dates

Study Major Dates

• Study Start (Actual): September 23, 2019
• Primary Completion (Actual): June 10, 2021
• Study Completion (Actual): June 10, 2021

Study Registration Dates

• First Submitted: September 16, 2019
• First Submitted That Met QC Criteria: September 17, 2019
• First Posted (Actual): September 19, 2019

Study Record Updates

• Last Update Posted (Actual): June 14, 2021
• Last Update Submitted That Met QC Criteria: June 11, 2021
• Last Verified: June 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Infertility; Infertility, Female; Physiological Effects of Drugs; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Dopamine Agonists; Dopamine Agents; Antiparkinson Agents; Anti-Dyskinesia Agents; Cabergoline
• Other Study ID Numbers: 19-FCLV-101

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No