Cabergoline Before or After Oocyte Collection for Follicular Resolution

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

70 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-09-23

Study Completion Date

2021-06-10

Brief Summary

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

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Detailed Description

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Conditions

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Infertility, Female

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

Laboratory personnel will not be informed of the subject's group assignment.

Study Groups

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Early administration

Cabergoline administered the day before egg collection.

Group Type EXPERIMENTAL

Cabergoline Pill

Intervention Type DRUG

0.5 mg cabergoline pill taken orally

Late administration

Cabergoline administered after egg collection.

Group Type EXPERIMENTAL

Cabergoline Pill

Intervention Type DRUG

0.5 mg cabergoline pill taken orally

Interventions

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Cabergoline Pill

0.5 mg cabergoline pill taken orally

Intervention Type DRUG

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes