Infertility, FemalePhase 4NCT04096027
Cabergoline Before or After Oocyte Collection for Follicular Resolution
A Phase 4 study testing Cabergoline Pill in people with Infertility, Female, run by Fertility Center of Las Vegas at 1 site in United States.
Trial summary
Randomized trial comparing the efficacy of two different times of administration of cabergoline in patients undergoing controlled ovarian stimulation and oocyte collection. Read more about this study
- Who is it for?
- Ages 18 years and older, women onlyHealthy volunteers can take part
- Conditions the study is for
- Infertility, Female
- What is being tested?
- Cabergoline Pill
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 70 participants
- Where
- 1 siteUnited States
- Study dates
- 23 Sep 2019to 10 Jun 2021
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Adult female at least 18 years of age intending to undergo ovarian stimulation for a cycle of IVF.
- Ability read and understand English sufficiently to obtain informed consent and complete a study diary.
- Pre-implantation genetic screening (PGS) is allowed.
- Egg donors are allowed.
- Patients using a gestational carrier are allowed.
- Patients with prior IVF cycles are allowed, but no patient can undergo more than one cycle with oocyte collection under this study.
Who cannot join
- Egg banking, donor egg banking, or any cycle type that would preclude immediate culture to blastocyst stage.
- 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).
- Uncontrolled hypertension.
- Ergot alkaloid hypersensitivity or allergy.
- History of pulmonary, pericardial, retroperitoneal fibrotic disorders.
- History of bipolar disorder, schizophrenia, or psychotic illness.
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- Breast feeding.
- History of eclampsia or pre-eclampsia.
- Severe hepatic dysfunction.
- 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).
- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site
Fertility Center of Las vegas
Las Vegas, Nevada, 89117
About this study
Randomized trial comparing the efficacy of two different times of administration of cabergoline in patients undergoing controlled ovarian stimulation and oocyte collection.
- Conditions
- Infertility, Female
- Being tested
- Cabergoline Pill
- Medical subject headings
- Infertility, Female
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cabergoline PillDrug
0.5 mg cabergoline pill taken orally
| Study group | Role | What they receive |
|---|---|---|
| Early administration | Experimental | Cabergoline administered the day before egg collection. Receives: Drug: Cabergoline Pill |
| Late administration | Experimental | Cabergoline administered after egg collection. Receives: Drug: Cabergoline Pill |
What is being measured
The primary outcome is the main question the study is designed to answer.
Discomfort level
Self-assessed discomfort level
Measured: 5 days after egg collection
Mature oocyte rate per follicular puncture
Ratio of mature oocytes obtained to punctured ovarian follicles
Measured: Within 24 hours of egg collection
Secondary outcomes (6)
Ovarian volume
Measured: 5 days post retrieval
oocyte count
Measured: Within 24 hours of egg collection
Oocyte to follicle ratio
Measured: Within 24 hours of egg collection
M1 oocyte rate
Measured: Within 24 hours of egg collection
M1 to M2 oocyte ratio
Measured: Within 24 hours of egg collection
Aneuploidy rate
Genetic test results of embryos for patients who opt for such testing.
Measured: Within 14 days of egg collection
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Sep 2019
- Study start23 Sep 2019
- Primary completion10 Jun 2021
- Study completion10 Jun 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Infertility, FemaleStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 70 participants (actual)
Sponsor and investigators
- Lead sponsor
- Fertility Center of Las Vegas
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Bruce Shapiro, MD, Principal investigator, Fertility Center of Las Vehas
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04096027
- Sponsor's protocol ID
- 19-FCLV-101
- Status last verified
- Jun 2021
- First submitted
- 16 Sep 2019
- Last updated
- 14 Jun 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Jun 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Cabergoline Before or After Oocyte Collection for Follicular Resolution
- ClinicalTrials.gov ID
- NCT04096027
- Acronym / sponsor ID
- 19-FCLV-101
- Conditions
- Infertility, Female
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 70 participants (actual)
- Lead sponsor
- Fertility Center of Las VegasIndustry (pharma, biotech, devices)
- Study start
- 23 Sep 2019 (actual)
- Primary completion
- 10 Jun 2021 (actual)
- Study completion
- 10 Jun 2021 (actual)
- First posted
- 19 Sep 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Randomized trial comparing the efficacy of two different times of administration of cabergoline in patients undergoing controlled ovarian stimulation and oocyte collection.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Early administration | Experimental | Drug: Cabergoline PillCabergoline administered the day before egg collection. |
| Late administration | Experimental | Drug: Cabergoline PillCabergoline administered after egg collection. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Adult female at least 18 years of age intending to undergo ovarian stimulation for a cycle of IVF.
- Ability read and understand English sufficiently to obtain informed consent and complete a study diary.
- Pre-implantation genetic screening (PGS) is allowed.
- Egg donors are allowed.
- Patients using a gestational carrier are allowed.
Key exclusion criteria (11 listed)
- Egg banking, donor egg banking, or any cycle type that would preclude immediate culture to blastocyst stage.
- 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).
- Uncontrolled hypertension.
- Ergot alkaloid hypersensitivity or allergy.
- History of pulmonary, pericardial, retroperitoneal fibrotic disorders.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Cabergoline Pill0.5 mg cabergoline pill taken orally | Drug | Early administration, Late administration |
Primary outcome
Discomfort level
Time frame: 5 days after egg collection
Self-assessed discomfort level
Mature oocyte rate per follicular puncture
Time frame: Within 24 hours of egg collection
Ratio of mature oocytes obtained to punctured ovarian follicles
6 secondary outcomes
Ovarian volume
Time frame: 5 days post retrieval
oocyte count
Time frame: Within 24 hours of egg collection
Oocyte to follicle ratio
Time frame: Within 24 hours of egg collection
M1 oocyte rate
Time frame: Within 24 hours of egg collection
M1 to M2 oocyte ratio
Time frame: Within 24 hours of egg collection
Aneuploidy rate
Time frame: Within 14 days of egg collection
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Jun 2021.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Bruce Shapiro, MD principal investigator
Fertility Center of Las Vehas
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Cabergoline Pill in people with Infertility, Female, run by Fertility Center of Las Vegas at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 14 Jun 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Discomfort level (time frame: 5 days after egg collection). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Jun 2021.