Cabergoline Before or After Oocyte Collection for Follicular Resolution

• Sponsor: Fertility Center of Las Vegas (Industry)
• Overall Status: Completed
• CT.gov ID: NCT04096027
• Collaborator: (none)
• Enrollment: 70
• Location: 1
• Arms: 2
• Actual Duration (Months): 20.6
• Patients Per Site Per Month: 3.4

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Infertility, Female	Drug: Cabergoline Pill	Phase 4

Study Design

• Study Type: Interventional
• Actual 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: Sep 23, 2019
• Actual Primary Completion Date: Jun 10, 2021
• Actual Study Completion Date: Jun 10, 2021

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

1. Discomfort level [5 days after egg collection]

   Self-assessed discomfort level

2. Mature oocyte rate per follicular puncture [Within 24 hours of egg collection]

   Ratio of mature oocytes obtained to punctured ovarian follicles

Secondary Outcome Measures

1. Ovarian volume [5 days post retrieval]

2. oocyte count [Within 24 hours of egg collection]

3. Oocyte to follicle ratio [Within 24 hours of egg collection]

4. M1 oocyte rate [Within 24 hours of egg collection]

5. M1 to M2 oocyte ratio [Within 24 hours of egg collection]

6. Aneuploidy rate [Within 14 days of egg collection]

   Genetic test results of embryos for patients who opt for such testing.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: Female
• Accepts Healthy Volunteers: Yes

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Fertility Center of Las vegas	Las Vegas	Nevada	United States	89117

Sponsors and Collaborators

• Fertility Center of Las Vegas

Investigators

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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Fertility Center of Las Vegas
• ClinicalTrials.gov Identifier: NCT04096027
• Other Study ID Numbers: 19-FCLV-101
• First Posted: Sep 19, 2019
• Last Update Posted: Jun 14, 2021
• Last Verified: Jun 1, 2021

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• 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: Infertility; Infertility, Female; Cabergoline

Study Results

No Results Posted as of Jun 14, 2021