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
Trial Snapshot
- Phase
- Phase 2
- Status
- Completed
- Sponsor
- Enrollment
- 107
- Locations
- 1
- Primary Endpoint
- prevention of OHSS occurrence
Study Overview
Brief 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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to 40 Years (Adult)
- Sex
- Female
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •patients undergoing ICSI who were considered at risk of developing OHSS:
- •polycystic ovaries and/or previous history of OHSS, AMH > 40 pmol/L but patients were finally included in the study if serum E2 levels reached >3000 pg/ml on day of hCG trigger or at any stage of folliculometry
- •age: 18-40
Exclusion Criteria
- •retrieval of less than 20 oocytes
- •age less than 18 or above 40
Arms & Interventions
Control group
patients at high risk for OHSS who are receiving conventional treatment either as a prophylaxis (in the form of bromocriptine) or as a management in case of developing OHSS (as continual bromocriptine and fluid monitoring and or paracentesis and or tube thoracostomy)
Intervention: Bromocriptine (Drug)
treatment group
patient who has developed OHSS while on conventional lines of management (as continual bromocriptine and fluid monitoring and or paracentesis and or tube thoracostomy) patients in this group, fludrocortisone was added to conventional lines of management.
Intervention: Fludrocortisone 0.1 Milligrams (mg) (Drug)
treatment group
patient who has developed OHSS while on conventional lines of management (as continual bromocriptine and fluid monitoring and or paracentesis and or tube thoracostomy) patients in this group, fludrocortisone was added to conventional lines of management.
Intervention: Bromocriptine (Drug)
prevention group
patients at high risk for OHSS who are receiving fludrocortisone as a prophylaxis
Intervention: Fludrocortisone 0.1 Milligrams (mg) (Drug)
Outcomes
Primary Outcomes
prevention of OHSS occurrence
Time Frame: 21 days
percentage of cases that has developed OHSS in both control and prevention groups
duration of recovery
Time Frame: 10 days
Time needed for full clinical recovery
Secondary Outcomes
No secondary outcomes reported
Investigators
Muhammad saber mahmoud sayed zeafan
Principal Investigator
Ganin Fertility Center