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OpenTrials
Completed

NCT Number: NCT04351126

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

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.

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Key information

Conditions

Ovarian Hyperstimulation Syndrome Adnexal Diseases Endocrine System Diseases Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Genital Diseases Genital Diseases, Female Gonadal Disorders Ovarian Diseases Urogenital Diseases

Age range

18 year–40 year

Sex eligibility

Female

Study type

Interventional

Phase

Phase 2

Primary location

Ganin Fertility Center

Cairo, Maadi, 11728, Egypt

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Fludrocortisone 0.1 Milligrams (mg)

Drug

0.2-0.6 mg/day of fludrocortisone is prescribed

Bromocriptine

Drug

2.5 mg prescribed Vaginally twice daily

Primary outcomes

  1. duration of recovery

    Time frame: 10 days

    Time needed for full clinical recovery

  2. prevention of OHSS occurrence

    Time frame: 21 days

    percentage of cases that has developed OHSS in both control and prevention groups

Sponsors and collaborators

Lead sponsor

Ganin Fertility Center

Other

Registry information

Official study 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

Important dates

Study start
2019
Primary completion
2020
Study completion
2020
First posted
Apr 17, 2020
Registry last updated
Apr 17, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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