Infertility, Female
Conditions
Brief summary
Randomized trial comparing the efficacy of two different times of administration of cabergoline in patients undergoing controlled ovarian stimulation and oocyte collection.
Interventions
DRUGCabergoline Pill
0.5 mg cabergoline pill taken orally
Sponsors
Fertility Center of Las Vegas
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Masking description
Laboratory personnel will not be informed of the subject's group assignment.
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Discomfort level | 5 days after egg collection | Self-assessed discomfort level |
| Mature oocyte rate per follicular puncture | Within 24 hours of egg collection | Ratio of mature oocytes obtained to punctured ovarian follicles |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Oocyte to follicle ratio | Within 24 hours of egg collection | — |
| M1 oocyte rate | Within 24 hours of egg collection | — |
| Ovarian volume | 5 days post retrieval | — |
| Aneuploidy rate | Within 14 days of egg collection | Genetic test results of embryos for patients who opt for such testing. |
| M1 to M2 oocyte ratio | Within 24 hours of egg collection | — |
| oocyte count | Within 24 hours of egg collection | — |
Countries
United States
Outcome results
None listed