Ignite Creation Date:
2024-05-06 @ 8:18 PM
Last Modification Date:
2024-10-26 @ 3:25 PM
Study NCT ID:
NCT06333691
Status:
COMPLETED
Last Update Posted:
2024-03-27
First Post:
2024-03-20
Brief Title:
Comparative Study Between Calcium Gluconate With Diosmin Cabergoline and Cabergoline With Diosmin
Sponsor:
Minia University
Organization:
Minia University
Study Overview
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
Status:
COMPLETED
Status Verified Date:
2024-03
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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 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
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 LHhCG 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
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 LHhCG 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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None