Comparative Study Between Calcium Gluconate With Diosmin, Cabergoline and Cabergoline With Diosmin
1 other identifier
interventional
180
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Oct 2022
1 active site
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Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
October 1, 2022
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 1, 2024
CompletedStudy Completion
Last participant's last visit for all outcomes
February 15, 2024
CompletedFirst Submitted
Initial submission to the registry
March 20, 2024
CompletedFirst Posted
Study publicly available on registry
March 27, 2024
CompletedJanuary 7, 2025
March 1, 2024
1.3 years
March 20, 2024
January 3, 2025
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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.
3 months
Study Arms (3)
Group A
ACTIVE COMPARATORAbout 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 COMPARATORAbout 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 COMPARATORAbout 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.
Interventions
to compare the effectiveness of calcium gluconate, cabergoline and diosmin in preventing ovarian hyperstimulation syndrome in high-risk patient undergoing ICSI procedure.
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Minia Universitylead
Study Sites (1)
Minia University, Faculty of Pharmacy
Minya, Egypt
Related Publications (1)
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.
PMID: 41221041DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY CHAIR
Hatem Sarhan, Professor
Professor of Pharmaceutics, Faculty of Pharmacy, Minia University.
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- OUTCOMES ASSESSOR
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Assistant lecturer in Clinical Pharmacy department
Study Record Dates
First Submitted
March 20, 2024
First Posted
March 27, 2024
Study Start
October 1, 2022
Primary Completion
February 1, 2024
Study Completion
February 15, 2024
Last Updated
January 7, 2025
Record last verified: 2024-03