Clinical trial NCT04096027: Cabergoline Before or After Oocyte Collection for Follicular Resolution
Official title: Cabergoline Before or After Oocyte Collection for Follicular Resolution
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Infertility, Female
Lead sponsor: Fertility Center of Las Vegas
Sponsor class: INDUSTRY
First posted: 2019-09-19
Enrollment: 70
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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


Eligibility 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.

Primary outcomes:
measure: Discomfort level
timeFrame: 5 days after egg collection
measure: Mature oocyte rate per follicular puncture
timeFrame: Within 24 hours of egg collection
Secondary outcomes:
measure: Ovarian volume
timeFrame: 5 days post retrieval
measure: oocyte count
timeFrame: Within 24 hours of egg collection
measure: Oocyte to follicle ratio
timeFrame: Within 24 hours of egg collection
measure: M1 oocyte rate
timeFrame: Within 24 hours of egg collection
measure: M1 to M2 oocyte ratio
timeFrame: Within 24 hours of egg collection
measure: Aneuploidy rate
timeFrame: Within 14 days of egg collection
Other outcomes:
Locations:
city: Las Vegas
country: United States
facility: Fertility Center of Las vegas
state: Nevada
Study officials:
affiliation: Fertility Center of Las Vehas
name: Bruce Shapiro, MD
role: PRINCIPAL_INVESTIGATOR
References: