Cabergoline Before or After Oocyte Collection for Follicular Resolution

Infertility, Female Clinical Trial

Official title:

Cabergoline Before or After Oocyte Collection for Follicular Resolution

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04096027
• Other study ID #: 19-FCLV-101
• Status: Completed
• Phase: Phase 4
• Start date: September 23, 2019
• Est. completion date: June 10, 2021

Study information

• Verified date: June 2021
• Source: Fertility Center of Las Vegas
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 70
• Est. completion date: June 10, 2021
• Est. primary completion date: June 10, 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Infertility
• Infertility, Female

Intervention

Drug:
• Cabergoline Pill
0.5 mg cabergoline pill taken orally

Locations

Country	Name	City	State
United States	Fertility Center of Las vegas	Las Vegas	Nevada

Sponsors (1)

Lead Sponsor	Collaborator
Fertility Center of Las Vegas

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Discomfort level	Self-assessed discomfort level	5 days after egg collection
Primary	Mature oocyte rate per follicular puncture	Ratio of mature oocytes obtained to punctured ovarian follicles	Within 24 hours of egg collection
Secondary	Ovarian volume		5 days post retrieval
Secondary	oocyte count		Within 24 hours of egg collection
Secondary	Oocyte to follicle ratio		Within 24 hours of egg collection
Secondary	M1 oocyte rate		Within 24 hours of egg collection
Secondary	M1 to M2 oocyte ratio		Within 24 hours of egg collection
Secondary	Aneuploidy rate	Genetic test results of embryos for patients who opt for such testing.	Within 14 days of egg collection