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

G

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)

Trial contacts and locations

0

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Data sourced from clinicaltrials.gov

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