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

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT04351126

Enrollment

107

Registered

2020-04-17

Start date

2019-04-01

Completion date

2020-02-29

Last updated

2020-04-17

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Ovarian Hyperstimulation Syndrome

Keywords

OHSS, Mineralocorticoid, aldosterone

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.

Interventions

DRUGFludrocortisone 0.1 Milligrams (mg)

0.2-0.6 mg/day of fludrocortisone is prescribed

DRUGBromocriptine

2.5 mg prescribed Vaginally twice daily

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

FEMALE

Age

18 Years to 40 Years

Healthy volunteers

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

Design outcomes

Primary

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

Countries

Egypt

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026