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Cabergoline Before or After Oocyte Collection for Follicular Resolution

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04096027
Recruitment Status : Recruiting
First Posted : September 19, 2019
Last Update Posted : February 5, 2020
Sponsor:
Information provided by (Responsible Party):
Fertility Center of Las Vegas

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

Condition or disease Intervention/treatment Phase
Infertility, Female Drug: Cabergoline Pill Phase 4

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 70 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Masking Description: Laboratory personnel will not be informed of the subject's group assignment.
Primary Purpose: Treatment
Official Title: Cabergoline Before or After Oocyte Collection for Follicular Resolution
Actual Study Start Date : September 23, 2019
Estimated Primary Completion Date : March 31, 2020
Estimated Study Completion Date : May 31, 2020

Resource links provided by the National Library of Medicine


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




Primary Outcome Measures :
  1. Discomfort level [ Time Frame: 5 days after egg collection ]
    Self-assessed discomfort level

  2. Mature oocyte rate per follicular puncture [ Time Frame: Within 24 hours of egg collection ]
    Ratio of mature oocytes obtained to punctured ovarian follicles


Secondary Outcome Measures :
  1. Ovarian volume [ Time Frame: 5 days post retrieval ]
  2. oocyte count [ Time Frame: Within 24 hours of egg collection ]
  3. Oocyte to follicle ratio [ Time Frame: Within 24 hours of egg collection ]
  4. M1 oocyte rate [ Time Frame: Within 24 hours of egg collection ]
  5. M1 to M2 oocyte ratio [ Time Frame: Within 24 hours of egg collection ]
  6. Aneuploidy rate [ Time Frame: Within 14 days of egg collection ]
    Genetic test results of embryos for patients who opt for such testing.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04096027


Contacts
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Contact: Bruce Shapiro, MD 7022541777 drshapiro@fertilitycenterlv.com

Locations
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United States, Nevada
Fertility Center of Las vegas Recruiting
Las Vegas, Nevada, United States, 89117
Contact: Arlyn Garcia    702-254-1777    arlyn@fertilitycenterlv.com   
Sponsors and Collaborators
Fertility Center of Las Vegas
Investigators
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Principal Investigator: Bruce Shapiro, MD Fertility Center of Las Vehas
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Responsible Party: Fertility Center of Las Vegas
ClinicalTrials.gov Identifier: NCT04096027    
Other Study ID Numbers: 19-FCLV-101
First Posted: September 19, 2019    Key Record Dates
Last Update Posted: February 5, 2020
Last Verified: September 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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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
Additional relevant MeSH terms:
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Infertility
Infertility, Female
Genital Diseases, Male
Genital Diseases, Female
Cabergoline
Antiparkinson Agents
Anti-Dyskinesia Agents
Dopamine Agonists
Dopamine Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs