Cabergoline Before or After Oocyte Collection for Follicular Resolution

Overview

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

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Treatment
    • Masking: Single (Outcomes Assessor)
  • Study Primary Completion Date: June 10, 2021

Interventions

  • Drug: Cabergoline Pill
    • 0.5 mg cabergoline pill taken orally

Arms, Groups and Cohorts

  • Experimental: Early administration
    • Cabergoline administered the day before egg collection.
  • Experimental: Late administration
    • Cabergoline administered after egg collection.

Clinical Trial Outcome Measures

Primary Measures

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

Secondary Measures

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

Participating in This Clinical Trial

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.

Gender Eligibility: Female

Minimum Age: 18 Years

Maximum Age: N/A

Are Healthy Volunteers Accepted: Accepts Healthy Volunteers

Investigator Details

  • Lead Sponsor
    • Fertility Center of Las Vegas
  • Provider of Information About this Clinical Study
    • Sponsor
  • Overall Official(s)
    • Bruce Shapiro, MD, Principal Investigator, Fertility Center of Las Vehas

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