Clinical trial

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

Name
Aya Mohammed
Description
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.
Trial arms
Trial start
2022-10-01
Estimated PCD
2024-02-01
Trial end
2024-02-15
Status
Completed
Treatment
Calcium Gluconate
to compare the effectiveness of calcium gluconate, cabergoline and diosmin in preventing ovarian hyperstimulation syndrome in high-risk patient undergoing ICSI procedure.
Arms:
Group A:(Calcium gluconate Group), Group B:(Cabergoline Group), Group C:(Diosmin Group)
Other names:
Cabergoline, Diosmin
Size
180
Primary endpoint
the incidence rate of moderate to severe OHSS.
3 months
Eligibility criteria
Inclusion Criteria: * 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 Exclusion Criteria: * 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.
Protocol
{'studyType': 'INTERVENTIONAL', 'phases': ['NA'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'PARALLEL', 'primaryPurpose': 'PREVENTION', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}}, 'enrollmentInfo': {'count': 180, 'type': 'ACTUAL'}}
Updated at
2024-03-27

1 organization

1 product

1 indication

Organization
Minia University