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

Phase 2

Completed

• Conditions: Ovarian Hyperstimulation Syndrome
• Interventions: Drug: Fludrocortisone 0.1 Milligrams (mg); Drug: Bromocriptine

• Registration Number: NCT04351126
• Lead Sponsor: Ganin Fertility Center

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 Timeline

• Study Start: 2019-04-01
• Primary Completion: 2020-02-25
• Study Completion: 2020-02-29
• Status Verified: 2020-04
• Study First Submitted: 2020-04-14
• Study First Submitted QC: 2020-04-16
• Last Update Submitted: 2020-04-16
• Study First Posted: 2020-04-17
• Last Update Posted: 2020-04-17

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 107

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
prevention group	Fludrocortisone 0.1 Milligrams (mg)	patients at high risk for OHSS who are receiving fludrocortisone as a prophylaxis
treatment group	Fludrocortisone 0.1 Milligrams (mg)	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.
Control group	Bromocriptine	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)
treatment group	Bromocriptine	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.

Primary Outcome Measures

Name	Time	Method
prevention of OHSS occurrence	21 days	percentage of cases that has developed OHSS in both control and prevention groups
duration of recovery	10 days	Time needed for full clinical recovery

Trial Locations

Locations (1)

Ganin Fertility Center; 🇪🇬 Cairo, Maadi, Egypt