Clinical Trial Details
— Status: Completed
Administrative data
| NCT number |
NCT06333691 |
| Other study ID # |
Aya Mohammed |
| Secondary ID |
|
| Status |
Completed |
| Phase |
N/A
|
| First received |
|
| Last updated |
|
| Start date |
October 1, 2022 |
| Est. completion date |
February 15, 2024 |
Study information
| Verified date |
March 2024 |
| Source |
Minia University |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Interventional
|
Clinical 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 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.
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
