Clinical trial NCT04351126: Management of Ovarian Hyperstimulation Syndrome as a State of Defective Mineralocorticoid Response
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Ovarian Hyperstimulation Syndrome
Keywords: OHSS
Mineralocorticoid
aldosterone
Lead sponsor: Ganin Fertility Center
Sponsor class: OTHER
First posted: 2020-04-17
Enrollment: 107
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: duration of recovery
timeFrame: 10 days
measure: prevention of OHSS occurrence
timeFrame: 21 days
Secondary outcomes:
Other outcomes:
Locations:
city: Cairo
country: Egypt
facility: Ganin Fertility Center
state: Maadi
Study officials:
affiliation: Ganin Fertility Center
name: Muhammad S Zeafan, MBBCH
role: PRINCIPAL_INVESTIGATOR
affiliation: Ganin Fertility Center
name: khaled M Elqusi, BSc
role: PRINCIPAL_INVESTIGATOR
affiliation: Ganin Fertility Center
name: Hossam Elattar, MBBCH
role: PRINCIPAL_INVESTIGATOR
affiliation: Ganin Fertility Center
name: Hosam Zaki, MSc, FRCOG
role: STUDY_DIRECTOR
References:
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