NCT04351126

Management of Ovarian Hyperstimulation Syndrome as a State of Defective Mineralocorticoid Response

Pathophysiology and Nature of Ovarian Hyperstimulation Syndrome (OHSS) as a Clinical Entity Could be Fully Explained and Effectively Managed as a State of Defective Mineralocorticoid Response

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 107 (actual)
• Sponsor: Ganin Fertility Center · Academic / Other
• Sex: Female
• Age: 18 Years – 40 Years
• Healthy volunteers: Not accepted

Summary

lines of evidence that support nature of ovarian hyperstimulation syndrome (OHSS) as "defective mineralocorticoid response" are cited, our hypothesis is tested clinically in both prophylaxis against and treatment of OHSS.

Detailed description

several studies state significant correlation between OHSS and activation of Renin-angiotensin-aldosterone system (RAAS), degree of activation of RAAS correlates with severity of OHSS. In OHSS there is a cascade of events that mainly involves capillary leak with resultant fluid shift and electrolytes imbalance, these consequences are more pronounced - according to our hypothesis - due to inadequate mineralocorticoid response/activity in susceptible individuals in the settings of high progesterone levels with its antimineralocorticoid property, OHSS can be interpreted as a (mineralocorticoid deficiency crisis) and may effectively be treated as being so, so we conducted this study to test the hypothesis in both treatment and prevention of OHSS.

Conditions

• Ovarian Hyperstimulation Syndrome

Interventions

Type	Name	Description
DRUG	Fludrocortisone 0.1 Milligrams (mg)	0.2-0.6 mg/day of fludrocortisone is prescribed
DRUG	Bromocriptine	2.5 mg prescribed Vaginally twice daily

Timeline

• Start date: 2019-04-01
• Primary completion: 2020-02-25
• Completion: 2020-02-29
• First posted: 2020-04-17
• Last updated: 2020-04-17

Locations

1 site across 1 country: Egypt