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

Primary Purpose

Ovarian Hyperstimulation Syndrome

Status
Completed
Phase
Phase 2
Locations
Egypt
Study Type
Interventional
Intervention
Fludrocortisone 0.1 Milligrams (mg)
Bromocriptine
Sponsored by
Ganin Fertility Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Ovarian Hyperstimulation Syndrome focused on measuring OHSS, Mineralocorticoid, aldosterone

Eligibility Criteria

18 Years - 40 Years (Adult)FemaleDoes not accept healthy volunteers

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

Sites / Locations

  • Ganin Fertility Center

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Other

Experimental

Experimental

Arm Label

Control group

treatment group

prevention group

Arm 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)

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.

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

Outcomes

Primary Outcome Measures

duration of recovery
Time needed for full clinical recovery
prevention of OHSS occurrence
percentage of cases that has developed OHSS in both control and prevention groups

Secondary Outcome Measures

Full Information

First Posted
April 14, 2020
Last Updated
April 16, 2020
Sponsor
Ganin Fertility Center
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1. Study Identification

Unique Protocol Identification Number
NCT04351126
Brief Title
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

2. Study Status

Record Verification Date
April 2020
Overall Recruitment Status
Completed
Study Start Date
April 1, 2019 (Actual)
Primary Completion Date
February 25, 2020 (Actual)
Study Completion Date
February 29, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Ganin Fertility Center

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Ovarian Hyperstimulation Syndrome
Keywords
OHSS, Mineralocorticoid, aldosterone

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
107 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Control group
Arm Type
Other
Arm 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)
Arm Title
treatment group
Arm Type
Experimental
Arm 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.
Arm Title
prevention group
Arm Type
Experimental
Arm Description
patients at high risk for OHSS who are receiving fludrocortisone as a prophylaxis
Intervention Type
Drug
Intervention Name(s)
Fludrocortisone 0.1 Milligrams (mg)
Intervention Description
0.2-0.6 mg/day of fludrocortisone is prescribed
Intervention Type
Drug
Intervention Name(s)
Bromocriptine
Intervention Description
2.5 mg prescribed Vaginally twice daily
Primary Outcome Measure Information:
Title
duration of recovery
Description
Time needed for full clinical recovery
Time Frame
10 days
Title
prevention of OHSS occurrence
Description
percentage of cases that has developed OHSS in both control and prevention groups
Time Frame
21 days

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
40 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Muhammad S Zeafan, MBBCH
Organizational Affiliation
Ganin Fertility Center
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
khaled M Elqusi, BSc
Organizational Affiliation
Ganin Fertility Center
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Hossam Elattar, MBBCH
Organizational Affiliation
Ganin Fertility Center
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Hosam Zaki, MSc, FRCOG
Organizational Affiliation
Ganin Fertility Center
Official's Role
Study Director
Facility Information:
Facility Name
Ganin Fertility Center
City
Cairo
State/Province
Maadi
ZIP/Postal Code
11728
Country
Egypt

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
2439386
Citation
Navot D, Margalioth EJ, Laufer N, Birkenfeld A, Relou A, Rosler A, Schenker JG. Direct correlation between plasma renin activity and severity of the ovarian hyperstimulation syndrome. Fertil Steril. 1987 Jul;48(1):57-61. doi: 10.1016/s0015-0282(16)59290-5.
Results Reference
background
PubMed Identifier
9147235
Citation
Delbaere A, Bergmann PJ, Englert Y. Features of the Renin-angiotensin system in ascites and pleural effusion during severe ovarian hyperstimulation syndrome. J Assist Reprod Genet. 1997 May;14(5):241-4. doi: 10.1007/BF02765823.
Results Reference
background
PubMed Identifier
24944027
Citation
Gomez-Sanchez E, Gomez-Sanchez CE. The multifaceted mineralocorticoid receptor. Compr Physiol. 2014 Jul;4(3):965-94. doi: 10.1002/cphy.c130044.
Results Reference
background
PubMed Identifier
1657498
Citation
Dunne FP, Barry DG, Ferriss JB, Grealy G, Murphy D. Changes in blood pressure during the normal menstrual cycle. Clin Sci (Lond). 1991 Oct;81(4):515-8. doi: 10.1042/cs0810515.
Results Reference
background
PubMed Identifier
9308783
Citation
Ujioka T, Matsuura K, Kawano T, Okamura H. Role of progesterone in capillary permeability in hyperstimulated rats. Hum Reprod. 1997 Aug;12(8):1629-34. doi: 10.1093/humrep/12.8.1629.
Results Reference
background
PubMed Identifier
12215328
Citation
Lainas T, Petsas G, Stavropoulou G, Alexopoulou E, Iliadis G, Minaretzis D. Administration of methylprednisolone to prevent severe ovarian hyperstimulation syndrome in patients undergoing in vitro fertilization. Fertil Steril. 2002 Sep;78(3):529-33. doi: 10.1016/s0015-0282(02)03290-9.
Results Reference
background
PubMed Identifier
25309860
Citation
Kim MK, Won HJ, Shim SH, Cha DH, Yoon TK. Spontaneous ovarian hyperstimulation syndrome following a thawed embryo transfer cycle. Clin Exp Reprod Med. 2014 Sep;41(3):140-5. doi: 10.5653/cerm.2014.41.3.140. Epub 2014 Sep 30.
Results Reference
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Management of Ovarian Hyperstimulation Syndrome as a State of Defective Mineralocorticoid Response

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