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

NCT ID: NCT04351126

Last Updated: 2020-04-17

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 107 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-04-01
• Study Completion Date: 2020-02-29

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.

Conditions

Ovarian Hyperstimulation Syndrome

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Control group

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)

Group Type: OTHER

Bromocriptine

Intervention Type: DRUG

2.5 mg prescribed Vaginally twice daily

treatment group

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.

Group Type: EXPERIMENTAL

Fludrocortisone 0.1 Milligrams (mg)

Intervention Type: DRUG

0.2-0.6 mg/day of fludrocortisone is prescribed

Bromocriptine

Intervention Type: DRUG

2.5 mg prescribed Vaginally twice daily

prevention group

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

Group Type: EXPERIMENTAL

Fludrocortisone 0.1 Milligrams (mg)

Intervention Type: DRUG

0.2-0.6 mg/day of fludrocortisone is prescribed

Interventions

Fludrocortisone 0.1 Milligrams (mg)

0.2-0.6 mg/day of fludrocortisone is prescribed

Intervention Type: DRUG

Bromocriptine

2.5 mg prescribed Vaginally twice daily

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

• 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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 40 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Ganin Fertility Center

OTHER

Sponsor Role: lead

Responsible Party

Muhammad saber mahmoud sayed zeafan

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Muhammad S Zeafan, MBBCH

Role: PRINCIPAL_INVESTIGATOR

Ganin Fertility Center

khaled M Elqusi, BSc

Role: PRINCIPAL_INVESTIGATOR

Ganin Fertility Center

Hossam Elattar, MBBCH

Role: PRINCIPAL_INVESTIGATOR

Ganin Fertility Center

Hosam Zaki, MSc, FRCOG

Role: STUDY_DIRECTOR

Ganin Fertility Center

Locations

Ganin Fertility Center

Cairo, Maadi, Egypt

Countries

Egypt

References

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.

Reference Type: BACKGROUND

PMID: 12215328 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 25309860 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 2439386 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 9147235 (View on PubMed)

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

Reference Type: BACKGROUND

PMID: 24944027 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 1657498 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 9308783 (View on PubMed)

Other Identifiers

MSM-01

Identifier Type: -

Identifier Source: org_study_id