Ovarian Hyperstimulation SyndromeNCT06333691
Comparative Study Between Calcium Gluconate With Diosmin, Cabergoline and Cabergoline With Diosmin
A study testing Calcium Gluconate in people with Ovarian Hyperstimulation Syndrome, run by Minia University at 1 site in Egypt.
Trial summary
Ovarian hyperstimulation syndrome is a potentially fatal iatrogenic condition. This syndrome is characterized by a sudden increase of the vascular permeability which results in the development of a massive extravascular exudate in the peritoneal cavity, pleural, pericardium causing ascites, pleural and pericardial… Read more about this study
- Who is it for?
- Ages 23 to 39 years, women only
- Conditions the study is for
- Ovarian Hyperstimulation Syndrome
- What is being tested?
- 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
- 180 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Oct 2022to 15 Feb 2024
- Phase
- Interventional
- 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 23 to 39 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- High risk patient for OHSS is defined as previous history of OHSS or > 24 antral follicles of the ovaries on base line ultrasound (polycystic ovary)
- During ovarian stimulation-increased number of small follicles (8-12 mm)
- High AMH
- Rapidly rising serum E2
- High serum E2 at hCG trigger (>3000 pg/ ml) or presence of > 20 follicles on the day of retrieval, by ultrasound examination or >20 oocytes retrieved
Who cannot join
- patients with endocrine disorder e.g diabetes mellitus, Cushing's disease, and congenital adrenal hyperplasia,
- Patients with hypertension,
- Patients systemic disease e.g asthma, collagen vascular disease, hypercholesterolemia and sickle cell anemia.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Comparative Study Between Calcium Gluconate With Diosmin, Cabergoline and Cabergoline With Diosmin in Prevention of Ovarian Hyperstimulation Syndrome in High-risk Women Undergoing Intracytoplasmic Sperm Injection (ICSI) Procedures
Ovarian hyperstimulation syndrome is a potentially fatal iatrogenic condition. This syndrome is characterized by a sudden increase of the vascular permeability which results in the development of a massive extravascular exudate in the peritoneal cavity, pleural, pericardium causing ascites, pleural and pericardial effusion.
Severe forms are also accompanied by electrolyte disturbances and cardiopulmonary, hepatic, renal, and hemoconcentration associated with increased thromboembolic risk.
This syndrome is avoidable by the judicious use of gonadotropins and careful monitoring of stimulation regimens.
Read the detailed description
Ovarian hyperstimulation syndrome is a potentially fatal iatrogenic condition.
The major step to prevent hyperstimulation syndrome is to determine high risk patients as presence of polycystic ovarian syndrome, younger women with greater ovarian responsiveness, use of super active GnRH agonists, development of multiple immature and intermediate follicle during treatment, exposure to LH/hCG and previous history of hyperstimulation syndrome.
In addition, many different preventive modalities have been attempted such as decreasing the dose of FSH, using minimal or mild stimulating protocol as GnRH antagonists, use of insulin sensitizing agent as metformin, reduction the use of all follicles, decreasing the dose of hCG and administration of drugs which decrease capillary permeability as cabergoline, calcium gluconate, albumin, letrozole, hydroxyethyl starch and glucocorticoids.
Several different drugs have been used for prevention of hyperstimulation syndromes.
These include albumin, hydroxyethyl starch, aspirin, calcium, cabergoline, letrozole, and glucocorticoids. However, there is insufficient evidence about the benefits of these drugs in preventing hyperstimulation syndrome. Dopamine agonists (cabergoline) and calcium gluconate infusion are the most widely used preventive drugs.
Although these drugs have comparable effectiveness in preventing hyperstimulation syndrome with fewer maternal side effects, calcium maybe associated with arrhythmia
Recently attention has been focused on the use of Diosmin as a potent venotonic agent that decrease vascular permeability by reducing the release of inflammatory mediator such as prostaglandin E2 and thromboxane.
A study found that the combined use of diosmin and cabergoline in high-risk women undergoing ART was competent in avoiding hyperstimulation syndrome than using cabergoline alone. Moreover, this combination does not affect pregnancy rate, miscarriage nor multiple pregnancy
- Conditions
- Ovarian Hyperstimulation Syndrome
- Being tested
- Calcium Gluconate
- Keywords
- Calcium gluconate, Diosmin, Cabergoline, ICSI
- Medical subject headings
- Ovarian Hyperstimulation Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Calcium GluconateDrug
Also called Cabergoline, Diosmin
to compare the effectiveness of calcium gluconate, cabergoline and diosmin in preventing ovarian hyperstimulation syndrome in high-risk patient undergoing ICSI procedure.
| Study group | Role | What they receive |
|---|---|---|
| Group A | Active comparator | About 60 women patients,in which took IV infusion of calcium gluconate (Calcionate 10ml of 10% calcium gluconate, Memphis) in 200ml saline within 30 minutes of ovum pickup and contained for the next 3 days in addition to diosmin 2 tablets (500mg) t.d.s for 2 weeks. Receives: Drug: Calcium Gluconate |
| Group B | Active comparator | About 60 women patients,in which took cabergoline (Dostinex 0.5 mg, Pfizer, Montreal, Canada) orally daily for 8 days after hCG triggering. Receives: Drug: Calcium Gluconate |
| Group C | Active comparator | About 60 women patients,in which took diosmin , 2 tablets (500mg) t.d.s for 2 weeks in addition to cabergoline 1 tablet 0.5 mg/day orally for 8 days starting at the day of hCG injection. Receives: Drug: Calcium Gluconate |
What is being measured
The primary outcome is the main question the study is designed to answer.
the incidence rate of moderate to severe OHSS.
OHSS is mainly characterized by abdominal distension, nausea, vomiting, diarrhea, hydrothorax, blood clotting disorders, and abnormal kidney function. Secondary outcomes included the clinical pregnancy rate, miscarriage rate, and live birth rate.
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Mar 2024
- Study start1 Oct 2022
- Primary completion1 Feb 2024
- Study completion15 Feb 2024
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 Ovarian Hyperstimulation SyndromeStudies 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 N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 180 participants (actual)
Sponsor and investigators
- Lead sponsor
- Minia University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Aya Mohammed Abdallah, Minia University
- Investigators
- Hatem Sarhan, Professor, Study chair, Professor of Pharmaceutics, Faculty of Pharmacy, Minia University.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06333691
- Sponsor's protocol ID
- Aya Mohammed
- Status last verified
- Mar 2024
- First submitted
- 20 Mar 2024
- Last updated
- 7 Jan 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Abdallah AM, Hussien AK, Alarfaj SJ, Elmasry TA, Kamal M, Sarhan H, Mosbeh MH, Sadek EM. Comparative study between calcium gluconate with diosmin, cabergoline, and cabergoline with diosmin in prevention of ovarian hyperstimulation syndrome in high-risk women undergoing intracytoplasmic sperm injection (ICSI) procedures. Front Pharmacol. 2025 Oct 27;16:1655866. doi: 10.3389/fphar.2025.1655866. eCollection 2025.
PubMed 41221041
Study at a glance
From the registry record, last updated by the sponsor on 7 Jan 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparative Study Between Calcium Gluconate With Diosmin, Cabergoline and Cabergoline With Diosmin in Prevention of Ovarian Hyperstimulation Syndrome in High-risk Women Undergoing Intracytoplasmic Sperm Injection (ICSI) Procedures
- ClinicalTrials.gov ID
- NCT06333691
- Acronym / sponsor ID
- Aya Mohammed
- Conditions
- Ovarian Hyperstimulation Syndrome
- Keywords
- Calcium gluconate, Diosmin, Cabergoline, ICSI
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 180 participants (actual)
- Lead sponsor
- Minia UniversityUniversity, hospital or other
- Study start
- 1 Oct 2022 (actual)
- Primary completion
- 1 Feb 2024 (actual)
- Study completion
- 15 Feb 2024 (actual)
- First posted
- 27 Mar 2024 (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.
Ovarian hyperstimulation syndrome is a potentially fatal iatrogenic condition. This syndrome is characterized by a sudden increase of the vascular permeability which results in the development of a massive extravascular exudate in the peritoneal cavity, pleural, pericardium causing ascites, pleural and pericardial effusion.
Severe forms are also accompanied by electrolyte disturbances and cardiopulmonary, hepatic, renal, and hemoconcentration associated with increased thromboembolic risk.
This syndrome is avoidable by the judicious use of gonadotropins and careful monitoring of stimulation regimens.
Detailed description
Ovarian hyperstimulation syndrome is a potentially fatal iatrogenic condition.
The major step to prevent hyperstimulation syndrome is to determine high risk patients as presence of polycystic ovarian syndrome, younger women with greater ovarian responsiveness, use of super active GnRH agonists, development of multiple immature and intermediate follicle during treatment, exposure to LH/hCG and previous history of hyperstimulation syndrome.
In addition, many different preventive modalities have been attempted such as decreasing the dose of FSH, using minimal or mild stimulating protocol as GnRH antagonists, use of insulin sensitizing agent as metformin, reduction the use of all follicles, decreasing the dose of hCG and administration of drugs which decrease capillary permeability as cabergoline, calcium gluconate, albumin, letrozole, hydroxyethyl starch and glucocorticoids.
Several different drugs have been used for prevention of hyperstimulation syndromes.
These include albumin, hydroxyethyl starch, aspirin, calcium, cabergoline, letrozole, and glucocorticoids. However, there is insufficient evidence about the benefits of these drugs in preventing hyperstimulation syndrome. Dopamine agonists (cabergoline) and calcium gluconate infusion are the most widely used preventive drugs.
Although these drugs have comparable effectiveness in preventing hyperstimulation syndrome with fewer maternal side effects, calcium maybe associated with arrhythmia
Recently attention has been focused on the use of Diosmin as a potent venotonic agent that decrease vascular permeability by reducing the release of inflammatory mediator such as prostaglandin E2 and thromboxane.
A study found that the combined use of diosmin and cabergoline in high-risk women undergoing ART was competent in avoiding hyperstimulation syndrome than using cabergoline alone. Moreover, this combination does not affect pregnancy rate, miscarriage nor multiple pregnancy
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Group A | Active comparator | Drug: Calcium GluconateAbout 60 women patients,in which took IV infusion of calcium gluconate (Calcionate 10ml of 10% calcium gluconate, Memphis) in 200ml saline within 30 minutes of ovum pickup and contained for the next 3 days in addition to diosmin 2 tablets (500mg) t.d.s for 2 weeks. |
| Group B | Active comparator | Drug: Calcium GluconateAbout 60 women patients,in which took cabergoline (Dostinex 0.5 mg, Pfizer, Montreal, Canada) orally daily for 8 days after hCG triggering. |
| Group C | Active comparator | Drug: Calcium GluconateAbout 60 women patients,in which took diosmin , 2 tablets (500mg) t.d.s for 2 weeks in addition to cabergoline 1 tablet 0.5 mg/day orally for 8 days starting at the day of hCG injection. |
Who may qualify
- Ages
- 23 to 39 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- High risk patient for OHSS is defined as previous history of OHSS or > 24 antral follicles of the ovaries on base line ultrasound (polycystic ovary)
- During ovarian stimulation-increased number of small follicles (8-12 mm)
- High AMH
- Rapidly rising serum E2
- High serum E2 at hCG trigger (>3000 pg/ ml) or presence of > 20 follicles on the day of retrieval, by ultrasound examination or >20 oocytes retrieved
Key exclusion criteria (3 listed)
- patients with endocrine disorder e.g diabetes mellitus, Cushing's disease, and congenital adrenal hyperplasia,
- Patients with hypertension,
- Patients systemic disease e.g asthma, collagen vascular disease, hypercholesterolemia and sickle cell anemia.
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 |
|---|---|---|
| Calcium GluconateAlso: Cabergoline, Diosminto compare the effectiveness of calcium gluconate, cabergoline and diosmin in preventing ovarian hyperstimulation syndrome in high-risk patient undergoing ICSI procedure. | Drug | Group A, Group B, Group C |
Primary outcome
the incidence rate of moderate to severe OHSS.
Time frame: 3 months
OHSS is mainly characterized by abdominal distension, nausea, vomiting, diarrhea, hydrothorax, blood clotting disorders, and abnormal kidney function. Secondary outcomes included the clinical pregnancy rate, miscarriage rate, and live birth rate.
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 7 Jan 2025.
- Derived from this study: PubMed 41221041Abdallah AM, Hussien AK, Alarfaj SJ, Elmasry TA, Kamal M, Sarhan H, Mosbeh MH, Sadek EM. Comparative study between calcium gluconate with diosmin, cabergoline, and cabergoline with diosmin in prevention of ovarian hyperstimulation syndrome in high-risk women undergoing intracytoplasmic sperm injection (ICSI) procedures. Front Pharmacol. 2025 Oct 27;16:1655866. doi: 10.3389/fphar.2025.1655866. eCollection 2025.
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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.
Hatem Sarhan, Professor study chair
Professor of Pharmaceutics, Faculty of Pharmacy, Minia University.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Calcium Gluconate in people with Ovarian Hyperstimulation Syndrome, run by Minia 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 5 inclusion and 3 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 7 Jan 2025. 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.
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?
the incidence rate of moderate to severe OHSS. (time frame: 3 months). 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 NCT06333691, 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 7 Jan 2025.