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Completed

NCT Number: NCT06333691

Comparative Study Between Calcium Gluconate With Diosmin, Cabergoline and Cabergoline With Diosmin

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.

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Key information

Age range

23 year–39 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Minia University, Faculty of Pharmacy

Minya, Egypt

About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Calcium Gluconate

Drug

to compare the effectiveness of calcium gluconate, cabergoline and diosmin in preventing ovarian hyperstimulation syndrome in high-risk patient undergoing ICSI procedure.

Other names: Cabergoline, Diosmin

Primary outcomes

  1. 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.

Sponsors and collaborators

Lead sponsor

Minia University

Other

Registry information

Official study 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

Important dates

Study start
2022
Primary completion
2024
Study completion
2024
First posted
Mar 27, 2024
Registry last updated
Jan 7, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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