Cabergoline Before or After Oocyte Collection for Follicular Resolution

Phase 4

Completed

• Conditions: Infertility, Female
• Interventions: Drug: Cabergoline Pill

• Registration Number: NCT04096027
• Lead Sponsor: 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2019-09-16
• Study First Submitted QC: 2019-09-17
• Study First Posted: 2019-09-19
• Study Start: 2019-09-23
• Status Verified: 2021-06
• Primary Completion: 2021-06-10
• Study Completion: 2021-06-10
• Last Update Submitted: 2021-06-11
• Last Update Posted: 2021-06-14

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 70

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Late administration	Cabergoline Pill	Cabergoline administered after egg collection.
Early administration	Cabergoline Pill	Cabergoline administered the day before egg collection.

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
M1 oocyte rate	Within 24 hours of egg collection
M1 to M2 oocyte ratio	Within 24 hours of egg collection
Aneuploidy rate	Within 14 days of egg collection	Genetic test results of embryos for patients who opt for such testing.
oocyte count	Within 24 hours of egg collection
Ovarian volume	5 days post retrieval
Oocyte to follicle ratio	Within 24 hours of egg collection

Trial Locations

Locations (1)

Fertility Center of Las vegas; 🇺🇸 Las Vegas, Nevada, United States