Ovarian HyperstimulationPhase 3NCT03473613
Cabergoline Versus Calcium Infusion in Ovarian Hyperstimulation Syndrome Prevention
A Phase 3 study testing Oral Cabergoline and Calcium Gluconate in people with Ovarian Hyperstimulation, run by Benha University at 1 site in Egypt.
Trial summary
Giving oral Cabergoline or calcium infusion in women at high risk for developing ovarian hyperstimulation syndrome in context of assisted reproductive technologies aiming in its prevention Read more about this study
- Who is it for?
- Ages 18 to 45 years, women only
- Conditions the study is for
- Ovarian Hyperstimulation
- What is being tested?
- Oral 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
- 230 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Oct 2014to 15 Apr 2017
- Phase
- Phase 3
- 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 45 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- women undergoing assisted reproductive technologies whom at high risk for developing ovarian hyperstimulation syndrome as with high basal antimullerian hormone ,excess antral follicular count ,high seum estradiol on day of humian choronic gonadotrophin
- Exclusion Criteria:women with other endocrinopathy as congenital adrenal hyperplasia , hyperprolactinemia,diabetes
- -
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Comparison of Cabergoline Versus Calcium Infusion in Ovarian Hyperstimulation Syndrome Prevention:Randomized Controlled Trial
Giving oral Cabergoline or calcium infusion in women at high risk for developing ovarian hyperstimulation syndrome in context of assisted reproductive technologies aiming in its prevention
Read the detailed description
Women undergoing in vitro fertilization or intracytoplasmic sperm injection whom were at high risk for developing ovarian hyperstimuation syndrome were received either oral Cabergoline.5mg tablets for 7days starting on ovum pick up day and continued for 7days or received 10ml of 10%calcium gluconate in 200ml normal saline on ovum pick up day and continued for 4days
- Conditions
- Ovarian Hyperstimulation
- Being tested
- Oral Cabergoline, Calcium Gluconate
- Keywords
- Calcium infusion, Cabergoline
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Oral CabergolineDrug
Also called Cabergamon
Giving oral Cabergoline tablet 0.5 milligram daily starting on ovum pick up day and continued for seven days
Calcium GluconateDrug
Also called Calcium
Giving 10 ml of 10 % calcium gluconate on 200 ml normal saline solution o.9% intravenously over thirty minutes starting on ovum pick up day and continued for four days
| Study group | Role | What they receive |
|---|---|---|
| Calcium infusion | Active comparator | 10ml 10%calcium gluconate in 200ml normal saline solution given intravenously over thirty minutes, on ovum pick up day and continued for 4days Receives: Drug: Calcium Gluconate |
| Oral Cabergoline | Active comparator | Receiving oral Cabergoline (cabergamon 0.5 milligram tablet ) from ovum pick up day and continued for 7days,once daily Receives: Drug: Oral Cabergoline |
What is being measured
The primary outcome is the main question the study is designed to answer.
Occurrence of ovarian hyperstimuation syndrome
Clinical condition occurred in context of assisted reproductive technologies in which there serous sacs fluid accumulation and hemoconcentration
Measured: 20 days from ovum pick up day
Secondary outcomes (3)
Types of ovarian hyperstimuation syndrome and severity
Clinical severity either mild ,moderate or severe and its type either early or late onst
Measured: 20 days from ovum pick up day
Chemical pregnancy
Positive human chorionic Gonadotropin in blood
Measured: 14 day from embryos transfer day
Clinical pregnancy
Intrauterine gestational sac
Measured: 5 week from embryos transfer day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Mar 2018
- Study start1 Oct 2014
- Primary completion15 Apr 2017
- Study completion15 Apr 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Ovarian HyperstimulationStudies of the same condition, open and under way.
- More trials run by Benha UniversityThe sponsor's other registered studies.
- 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 3
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 230 participants (actual)
Sponsor and investigators
- Lead sponsor
- Benha University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, ashraf nassif mahmoud elmantwe,MD, Benha University
- Investigators
- Ashraf N Elmantwe, MD, Principal investigator, Benha University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03473613
- Sponsor's protocol ID
- Ashraf Elmantwe 1
- Status last verified
- Mar 2018
- First submitted
- 22 Feb 2018
- Last updated
- 29 Mar 2018
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Contact investigators
Study at a glance
From the registry record, last updated by the sponsor on 29 Mar 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Cabergoline Versus Calcium Infusion in Ovarian Hyperstimulation Syndrome Prevention:Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT03473613
- Acronym / sponsor ID
- Ashraf Elmantwe 1
- Conditions
- Ovarian Hyperstimulation
- Keywords
- Calcium infusion, Cabergoline
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 230 participants (actual)
- Lead sponsor
- Benha UniversityUniversity, hospital or other
- Study start
- 1 Oct 2014 (actual)
- Primary completion
- 15 Apr 2017 (actual)
- Study completion
- 15 Apr 2017 (actual)
- First posted
- 22 Mar 2018 (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.
Giving oral Cabergoline or calcium infusion in women at high risk for developing ovarian hyperstimulation syndrome in context of assisted reproductive technologies aiming in its prevention
Detailed description
Women undergoing in vitro fertilization or intracytoplasmic sperm injection whom were at high risk for developing ovarian hyperstimuation syndrome were received either oral Cabergoline.5mg tablets for 7days starting on ovum pick up day and continued for 7days or received 10ml of 10%calcium gluconate in 200ml normal saline on ovum pick up day and continued for 4days
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Calcium infusion | Active comparator | Drug: Calcium Gluconate10ml 10%calcium gluconate in 200ml normal saline solution given intravenously over thirty minutes, on ovum pick up day and continued for 4days |
| Oral Cabergoline | Active comparator | Drug: Oral CabergolineReceiving oral Cabergoline (cabergamon 0.5 milligram tablet ) from ovum pick up day and continued for 7days,once daily |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- women undergoing assisted reproductive technologies whom at high risk for developing ovarian hyperstimulation syndrome as with high basal antimullerian hormone ,excess antral follicular count ,high seum estradiol on day of humian choronic gonadotrophin
- Exclusion Criteria:women with other endocrinopathy as congenital adrenal hyperplasia , hyperprolactinemia,diabetes
- -
Key exclusion criteria (0 listed)
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 |
|---|---|---|
| Oral CabergolineAlso: CabergamonGiving oral Cabergoline tablet 0.5 milligram daily starting on ovum pick up day and continued for seven days | Drug | Oral Cabergoline |
| Calcium GluconateAlso: CalciumGiving 10 ml of 10 % calcium gluconate on 200 ml normal saline solution o.9% intravenously over thirty minutes starting on ovum pick up day and continued for four days | Drug | Calcium infusion |
Primary outcome
Occurrence of ovarian hyperstimuation syndrome
Time frame: 20 days from ovum pick up day
Clinical condition occurred in context of assisted reproductive technologies in which there serous sacs fluid accumulation and hemoconcentration
3 secondary outcomes
Types of ovarian hyperstimuation syndrome and severity
Time frame: 20 days from ovum pick up day
Chemical pregnancy
Time frame: 14 day from embryos transfer day
Clinical pregnancy
Time frame: 5 week from embryos transfer day
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 29 Mar 2018.
- Individual participant dataSharing planned: No. Contact investigators
Related trials for Ovarian Hyperstimulation
RecruitingPhase 2
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Serum FSH Levels During Controlled Ovarian Stimulation
Female Subjects Undergoing Controlled Ovarian Hyperstimulation
Recruiting
Ovarian Hyperstimulation and Fibrin Clot Properties.
Fibrin Blood Clot, Infertility, Female
Active, not recruitingPhase 2
Identify Effective Doses of LY01021 in Controlled Ovarian Hyperstimulation (COH) for Female Subjects Undergoing Assisted Reproductive Technology (ART)
Assisted Reproduction
RecruitingObservational study
Real-world Evidence on Follitropin Delta Individual Dosing
Infertility, Sterility
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.
Ashraf N Elmantwe, MD principal investigator
Benha University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Oral Cabergoline and Calcium Gluconate in people with Ovarian Hyperstimulation, run by Benha University at 1 site 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 3 inclusion and 0 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 29 Mar 2018. 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 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
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?
Occurrence of ovarian hyperstimuation syndrome (time frame: 20 days from ovum pick up day). 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 29 Mar 2018.