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Cabergoline Before or After Oocyte Collection for Follicular Resolution

Primary Purpose

Infertility, Female

Status
Completed
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
Cabergoline Pill
Sponsored by
Fertility Center of Las Vegas
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Infertility, Female

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)FemaleAccepts Healthy Volunteers

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.

Sites / Locations

  • Fertility Center of Las vegas

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

Early administration

Late administration

Arm Description

Cabergoline administered the day before egg collection.

Cabergoline administered after egg collection.

Outcomes

Primary Outcome Measures

Discomfort level
Self-assessed discomfort level
Mature oocyte rate per follicular puncture
Ratio of mature oocytes obtained to punctured ovarian follicles

Secondary Outcome Measures

Ovarian volume
oocyte count
Oocyte to follicle ratio
M1 oocyte rate
M1 to M2 oocyte ratio
Aneuploidy rate
Genetic test results of embryos for patients who opt for such testing.

Full Information

First Posted
September 16, 2019
Last Updated
June 11, 2021
Sponsor
Fertility Center of Las Vegas
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1. Study Identification

Unique Protocol Identification Number
NCT04096027
Brief Title
Cabergoline Before or After Oocyte Collection for Follicular Resolution
Official Title
Cabergoline Before or After Oocyte Collection for Follicular Resolution
Study Type
Interventional

2. Study Status

Record Verification Date
June 2021
Overall Recruitment Status
Completed
Study Start Date
September 23, 2019 (Actual)
Primary Completion Date
June 10, 2021 (Actual)
Study Completion Date
June 10, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Fertility Center of Las Vegas

4. Oversight

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
Data Monitoring Committee
No

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Infertility, Female

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Masking Description
Laboratory personnel will not be informed of the subject's group assignment.
Allocation
Randomized
Enrollment
70 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Early administration
Arm Type
Experimental
Arm Description
Cabergoline administered the day before egg collection.
Arm Title
Late administration
Arm Type
Experimental
Arm Description
Cabergoline administered after egg collection.
Intervention Type
Drug
Intervention Name(s)
Cabergoline Pill
Intervention Description
0.5 mg cabergoline pill taken orally
Primary Outcome Measure Information:
Title
Discomfort level
Description
Self-assessed discomfort level
Time Frame
5 days after egg collection
Title
Mature oocyte rate per follicular puncture
Description
Ratio of mature oocytes obtained to punctured ovarian follicles
Time Frame
Within 24 hours of egg collection
Secondary Outcome Measure Information:
Title
Ovarian volume
Time Frame
5 days post retrieval
Title
oocyte count
Time Frame
Within 24 hours of egg collection
Title
Oocyte to follicle ratio
Time Frame
Within 24 hours of egg collection
Title
M1 oocyte rate
Time Frame
Within 24 hours of egg collection
Title
M1 to M2 oocyte ratio
Time Frame
Within 24 hours of egg collection
Title
Aneuploidy rate
Description
Genetic test results of embryos for patients who opt for such testing.
Time Frame
Within 14 days of egg collection

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Bruce Shapiro, MD
Organizational Affiliation
Fertility Center of Las Vehas
Official's Role
Principal Investigator
Facility Information:
Facility Name
Fertility Center of Las vegas
City
Las Vegas
State/Province
Nevada
ZIP/Postal Code
89117
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No

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Cabergoline Before or After Oocyte Collection for Follicular Resolution

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