A Phase 2 interventional study of Fludrocortisone 0.1 Milligrams (mg) and Bromocriptine in Ovarian Hyperstimulation Syndrome, sponsored by Ganin Fertility Center. Completed at 1 site in Egypt. Open to female participants aged 18 Years to 40 Years. Per ClinicalTrials.gov, last updated 2020-04-17.
Sponsored by Ganin Fertility Center · Phase 2, Interventional, and Treatment
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.
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.
64 studies on the registry are indexed under Ovarian Hyperstimulation Syndrome; 3 are open to participants now.
This study's enrollment of 107 is close to the median of 100 across 48 interventional studies indexed under Ovarian Hyperstimulation Syndrome.
Browse Ovarian Hyperstimulation Syndrome studies →Ganin Fertility Center is the lead sponsor of 15 studies on the registry; none are open to participants now.
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Inclusion Criteria: patients undergoing ICSI who were considered at risk of developing OHSS:
Exclusion Criteria:
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)
Drug: 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.
Drug: Fludrocortisone 0.1 Milligrams (mg) · Drug: Bromocriptine
patients at high risk for OHSS who are receiving fludrocortisone as a prophylaxis
Drug: Fludrocortisone 0.1 Milligrams (mg)
0.2-0.6 mg/day of fludrocortisone is prescribed
2.5 mg prescribed Vaginally twice daily
duration of recovery
Time needed for full clinical recovery
Time frame: 10 days
prevention of OHSS occurrence
percentage of cases that has developed OHSS in both control and prevention groups
Time frame: 21 days
Plan to share: No
This study is completed, as verified in Apr 2020. You cannot join it, but the record below documents what was studied.
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Ovarian Hyperstimulation Syndrome→
Ganin Fertility Center