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

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.

Official Title
-----------------
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

Conditions
-----------------
Ovarian Hyperstimulation Syndrome

Intervention / Treatment
-----------------
* Drug: Fludrocortisone 0.1 Milligrams (mg)
* Drug: Bromocriptine


Participation Criteria
=================
Eligibility Criteria
-----------------
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

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 40 Years

Sexes Eligible for Study
-----------------
Female

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Control group<br>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) | Drug: Bromocriptine<br>* 2.5 mg prescribed Vaginally twice daily<br>|
| Experimental: treatment group<br>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. | Drug: Fludrocortisone 0.1 Milligrams (mg)<br>* 0.2-0.6 mg/day of fludrocortisone is prescribed<br>Drug: Bromocriptine<br>* 2.5 mg prescribed Vaginally twice daily<br>|
| Experimental: prevention group<br>patients at high risk for OHSS who are receiving fludrocortisone as a prophylaxis | Drug: Fludrocortisone 0.1 Milligrams (mg)<br>* 0.2-0.6 mg/day of fludrocortisone is prescribed<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| duration of recovery | Time needed for full clinical recovery | 10 days | 
| prevention of OHSS occurrence | percentage of cases that has developed OHSS in both control and prevention groups | 21 days | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
OHSS, Mineralocorticoid, aldosterone