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

Ganin Fertility Center

Status and phase: Completed; Phase 2

Conditions: Ovarian Hyperstimulation Syndrome

Treatments: Drug: Fludrocortisone 0.1 Milligrams (mg); Drug: Bromocriptine

Study type: Interventional

Funder types: Other

Identifiers

NCT04351126

MSM-01

Details and patient eligibility

About

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.

Full 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.

Enrollment: 107 patients

Sex: Female

Ages: 18 to 40 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

---

107 participants in 3 patient groups

Control group

Other group

Description:

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:

Drug: Bromocriptine

treatment group

Experimental group

Description:

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.

Treatment:

Drug: Bromocriptine

Drug: Fludrocortisone 0.1 Milligrams (mg)

prevention group

Experimental group

Description:

patients at high risk for OHSS who are receiving fludrocortisone as a prophylaxis

Treatment:

Drug: Fludrocortisone 0.1 Milligrams (mg)