NCT04096027

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
70

participants targeted

Target at P25-P50 for phase_4

Timeline
Completed

Started Sep 2019

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 16, 2019

Completed
3 days until next milestone

First Posted

Study publicly available on registry

September 19, 2019

Completed
4 days until next milestone

Study Start

First participant enrolled

September 23, 2019

Completed
1.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 10, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 10, 2021

Completed
Last Updated

June 14, 2021

Status Verified

June 1, 2021

Enrollment Period

1.7 years

First QC Date

September 16, 2019

Last Update Submit

June 11, 2021

Conditions

Infertility, Female

Outcome Measures

Primary Outcomes (2)

  • 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 Outcomes (6)

  • 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

  • +1 more secondary outcomes

Study Arms (2)

Early administration

EXPERIMENTAL

Cabergoline administered the day before egg collection.

Drug: Cabergoline Pill

Late administration

EXPERIMENTAL

Cabergoline administered after egg collection.

Drug: Cabergoline Pill

Interventions

Cabergoline PillDRUG

0.5 mg cabergoline pill taken orally

Early administrationLate administration

Eligibility Criteria

Age18 Years+
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Fertility Center of Las vegas

Las Vegas, Nevada, 89117, United States

Location

MeSH Terms

Conditions

Infertility, Female

Interventions

Cabergoline

Condition Hierarchy (Ancestors)

Genital Diseases, FemaleFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesGenital DiseasesInfertility

Intervention Hierarchy (Ancestors)

ErgolinesErgot AlkaloidsAlkaloidsHeterocyclic CompoundsHeterocyclic Compounds, 4 or More RingsHeterocyclic Compounds, Fused-Ring

Study Officials

  • Bruce Shapiro, MD

    Fertility Center of Las Vehas

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Masking Details
Laboratory personnel will not be informed of the subject's group assignment.
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 16, 2019

First Posted

September 19, 2019

Study Start

September 23, 2019

Primary Completion

June 10, 2021

Study Completion

June 10, 2021

Last Updated

June 14, 2021

Record last verified: 2021-06

Data Sharing

IPD Sharing
Will not share

Locations

US(1)