OHSSPhase 2NCT02875587

Cabergoline Versus Calcium Gluconate Infusion in the Prevention of Ovarian Hyperstimulation Syndrome

A Phase 2 study testing Cabergoline and Calcium gluconate in people with OHSS, run by Aljazeera Hospital at 2 sites in Egypt.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

The aim of this study is to compare the efficacy of calcium gluconate infusion versus cabergoline in the prevention of ovarian hyperstimulation syndrome (OHSS) in patients pretreated with GnRH agonist long protocol who are at high risk for OHSS. Read more about this study

Who is it for?: Ages 18 to 37 years, women only
Conditions the study is for: OHSS
What is being tested?: Cabergoline and Calcium gluconate
Type of treatment: Pill or oral medicine, Injection or infusion
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 170 participants
Where: 2 sitesEgypt
Study dates: Oct 2016to Dec 2018
Phase: Phase 2
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 to 37 years
Women only
No healthy volunteers
Adult

Who may be able to join

Patients who are stimulated using the long luteal GnRH agonist protocol and at high risk for developing OHSS [have more than 18 follicles (> 11mm) and serum estradiol ≥ 3000 pg/ml on the day of HCG administration].

Who cannot join

Fibrosis of lung
Swelling or inflammation around the heart or lung
Hypertension
Liver disease
Heart valve disease and allergy to cabergoline or ergot derivatives.

Trial locations and contacts

2 sites in 1 country.

Egypt2 sites

Aljazeera hospital
Giza
Riyadh Fertility and Reproductive Health center
Giza

Other trials in Egypt

About this study

Official title: Cabergoline Versus Calcium Gluconate Infusion in the Prevention of Ovarian Hyperstimulation Syndrome. A Randomized Controlled Trial

Read the detailed description

Ovarian hyperstimulation syndrome (OHSS) is a serious complication of assisted reproduction.

Previous studies revealed that calcium gluconate infusion reduced the risk of OHSS. Other studies revealed that cabergoline (potent dopamine receptor agonist on D2 receptors)was effective in preventing OHSS.

Conditions: OHSS
Being tested: Cabergoline, Calcium gluconate
Keywords: OHSS, Infertility, Cabergoline, Calcium gluconate, IVF-ET
Medical subject headings: Infertility

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

CabergolineDrug
Cabergoline (Dostinex; Pfizer, Italy) at a daily dose of 0.5 mg is administered orally at bed time for 8 days starting on the day of HCG administration
Calcium gluconateDrug
Intravenous 10% calcium gluconate, 10 mL in 200 mL of physiologic saline on the day of ovum pickup, day 1, day 2, and day 3 after ovum pickup. Intravenous infusion will be performed within 30 minutes.

Study groups in NCT02875587
Study group	Role	What they receive
Cabergoline group	Active comparator	Cabergoline is administered starting on the day of HCG administration. Receives: Drug: Cabergoline
Calcium gluconate infusion group	Experimental	Calcium gluconate is administered starting on the day of HCG administration. Receives: Drug: Calcium gluconate

What is being measured

The primary outcome is the main question the study is designed to answer.

Moderate or severe ovarian hyperstimulation syndrome
Measured: Within 4 weeks of HCG adminstration

Secondary outcomes (1)

The Number of Participants Who Achieved Ongoing Pregnancy
Measured: 18 weeks after embryo transfer

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Oct 2016Dec 2018

First posted23 Aug 2016 (estimated)
Study startOct 2016
Primary completionAug 2018
Study completionDec 2018

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Publications (1)Papers the sponsor has linked to this study.
Other trials for OHSSStudies 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 2
Primary purpose: Prevention
Allocation: Randomised
Intervention model: Parallel groups
Masking: Single blind
Who is masked: Outcomes assessor
Enrolment: 170 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT02875587
Sponsor's protocol ID: Cabergoline/calcium gluconate
Status last verified: Dec 2018
First submitted: 18 Aug 2016
Last updated: 27 Dec 2018
Results posted: No
Data monitoring committee: Yes
Individual data sharing: No

Publications

Gurgan T, Demirol A, Guven S, Benkhalifa M, Girgin B, Li TC. Intravenous calcium infusion as a novel preventive therapy of ovarian hyperstimulation syndrome for patients with polycystic ovarian syndrome. Fertil Steril. 2011 Jul;96(1):53-7. doi: 10.1016/j.fertnstert.2011.04.094. Epub 2011 May 31.
PubMed 21621772

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

Not yet recruiting
Oral GnRH Antagonist (Linzagolix) Versus Injectable GnRH Antagonist in Controlled Ovarian Stimulation for In Vitro Fertilization: A Randomized Controlled Non-Inferiority Trial With a Concurrent Comparator Cohort Undergoing Progestin-Primed Ovarian Stimulation (PPOS)
Infertility, Female, Ovulation Induction
RecruitingPhase 2
Clinical Study to Evaluate Efficacy of Cabergoline to Coasting in Reducing the Incidence of Ovarian Hyperstimulation Syndrome
Gynecologic Disease
RecruitingObservational study
Real-world Evidence on Follitropin Delta Individual Dosing
Infertility, Sterility
Recruiting
Ovarian Hyperstimulation Syndrome Prevention
Ovarian Hyper Stimulation Syndrome (OHSS)

All OHSS trials

Study at a glance

From the registry record, last updated by the sponsor on 27 Dec 2018. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Cabergoline Versus Calcium Gluconate Infusion in the Prevention of Ovarian Hyperstimulation Syndrome. A Randomized Controlled Trial
ClinicalTrials.gov ID: NCT02875587
Acronym / sponsor ID: Cabergoline/calcium gluconate
Conditions: OHSS
Keywords: OHSS, Infertility, Cabergoline, Calcium gluconate, IVF-ET
Phase: Phase 2
Study type: Interventional
Recruitment status: Completed
Enrolment: 170 participants (actual)
Lead sponsor: Aljazeera HospitalUniversity, hospital or other
Study start: Oct 2016
Primary completion: Aug 2018 (actual)
Study completion: Dec 2018 (actual)
First posted: 23 Aug 2016 (estimated)
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.

Detailed description

Ovarian hyperstimulation syndrome (OHSS) is a serious complication of assisted reproduction.

Study design

Primary purpose: Prevention
Allocation: Randomised
Intervention model: Parallel groups
Masking: Single blind (outcomes assessor)
Number of arms: 2

Arm	Type	Receives
Cabergoline group	Active comparator	Drug: CabergolineCabergoline is administered starting on the day of HCG administration.
Calcium gluconate infusion group	Experimental	Drug: Calcium gluconateCalcium gluconate is administered starting on the day of HCG administration.

Who may qualify

Ages: 18 to 37 years
Sex: Female only
Healthy volunteers: Not accepted
Age groups: Adult

Key inclusion criteria (1 listed)

Patients who are stimulated using the long luteal GnRH agonist protocol and at high risk for developing OHSS [have more than 18 follicles (> 11mm) and serum estradiol ≥ 3000 pg/ml on the day of HCG administration].

Key exclusion criteria (5 listed)

Fibrosis of lung
Swelling or inflammation around the heart or lung
Hypertension
Liver disease
Heart valve disease and allergy to cabergoline or ergot derivatives.

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
CabergolineCabergoline (Dostinex; Pfizer, Italy) at a daily dose of 0.5 mg is administered orally at bed time for 8 days starting on the day of HCG administration	Drug	Cabergoline group
Calcium gluconateIntravenous 10% calcium gluconate, 10 mL in 200 mL of physiologic saline on the day of ovum pickup, day 1, day 2, and day 3 after ovum pickup. Intravenous infusion will be performed within 30 minutes.	Drug	Calcium gluconate infusion group

Primary outcome

Moderate or severe ovarian hyperstimulation syndrome
Time frame: Within 4 weeks of HCG adminstration

1 secondary outcome

The Number of Participants Who Achieved Ongoing Pregnancy
Time frame: 18 weeks after embryo transfer

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 27 Dec 2018.
Background: PubMed 21621772Gurgan T, Demirol A, Guven S, Benkhalifa M, Girgin B, Li TC. Intravenous calcium infusion as a novel preventive therapy of ovarian hyperstimulation syndrome for patients with polycystic ovarian syndrome. Fertil Steril. 2011 Jul;96(1):53-7. doi: 10.1016/j.fertnstert.2011.04.094. Epub 2011 May 31.
Individual participant dataSharing planned: No

Related trials for OHSS

Not yet recruiting
Oral GnRH Antagonist (Linzagolix) Versus Injectable GnRH Antagonist in Controlled Ovarian Stimulation for In Vitro Fertilization: A Randomized Controlled Non-Inferiority Trial With a Concurrent Comparator Cohort Undergoing Progestin-Primed Ovarian Stimulation (PPOS)
Infertility, Female, Ovulation Induction
RecruitingPhase 2
Clinical Study to Evaluate Efficacy of Cabergoline to Coasting in Reducing the Incidence of Ovarian Hyperstimulation Syndrome
Gynecologic Disease
RecruitingObservational study
Real-world Evidence on Follitropin Delta Individual Dosing
Infertility, Sterility
Recruiting
Ovarian Hyperstimulation Syndrome Prevention
Ovarian Hyper Stimulation Syndrome (OHSS)

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.

Usama M Fouda, M.D,PhD study chair

Aljazeera( Al Gazeera) hospital

2 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Cabergoline and Calcium gluconate in people with OHSS, run by Aljazeera Hospital at 2 sites in Egypt.

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 1 inclusion and 5 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 27 Dec 2018. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in Egypt. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

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?

Moderate or severe ovarian hyperstimulation syndrome (time frame: Within 4 weeks of HCG adminstration). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02875587, which also lists 1 linked publication.

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 27 Dec 2018.