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

Ovarian Hyperstimulation Syndrome Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04351126
• Other study ID #: MSM-01
• Status: Completed
• Phase: Phase 2
• Start date: April 1, 2019
• Est. completion date: February 29, 2020

Study information

• Verified date: April 2020
• Source: Ganin Fertility Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 107
• Est. completion date: February 29, 2020
• Est. primary completion date: February 25, 2020
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 40 Years

Eligibility

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

Related Conditions & MeSH terms

• Ovarian Hyperstimulation Syndrome
• Syndrome

Intervention

Drug:
• Fludrocortisone 0.1 Milligrams (mg)
0.2-0.6 mg/day of fludrocortisone is prescribed
• Bromocriptine
2.5 mg prescribed Vaginally twice daily

Locations

Country	Name	City	State
Egypt	Ganin Fertility Center	Cairo	Maadi

Sponsors (1)

Lead Sponsor	Collaborator
Ganin Fertility Center

Country where clinical trial is conducted

Egypt, 

References & Publications (7)

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. — View 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. — View Citation

Gomez-Sanchez E, Gomez-Sanchez CE. The multifaceted mineralocorticoid receptor. Compr Physiol. 2014 Jul;4(3):965-94. doi: 10.1002/cphy.c130044. Review. — View 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. — View 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. — View 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. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	duration of recovery	Time needed for full clinical recovery	10 days
Primary	prevention of OHSS occurrence	percentage of cases that has developed OHSS in both control and prevention groups	21 days