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

NCT04351126 | Completed Phase 2

• 1 other identifier: MSM-01
• Study Type: interventional
• Target: 107
• Locations: 1 country
• Sites: 1

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.

Conditions

Ovarian Hyperstimulation Syndrome

Keywords

OHSS; Mineralocorticoid; aldosterone

Outcome Measures

Primary Outcomes (2)

• duration of recovery

  Time needed for full clinical recovery

  10 days

• prevention of OHSS occurrence

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

  21 days

Study Arms (3)

Control group

OTHER

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

treatment group

EXPERIMENTAL

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

prevention group

EXPERIMENTAL

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

Drug: Fludrocortisone 0.1 Milligrams (mg)

Interventions

Fludrocortisone 0.1 Milligrams (mg) DRUG

0.2-0.6 mg/day of fludrocortisone is prescribed

prevention group; treatment group

Bromocriptine DRUG

2.5 mg prescribed Vaginally twice daily

Control group; treatment group

Eligibility Criteria

• Age: 18 Years - 40 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• retrieval of less than 20 oocytes
• age less than 18 or above 40

Sponsors & Collaborators

• Ganin Fertility Center: lead

Study Sites (1)

Ganin Fertility Center

Cairo, Maadi, 11728, Egypt

Location

Related Publications (7)

• 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.

  PMID: 2439386 BACKGROUND

• 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.

  PMID: 9147235 BACKGROUND

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

  PMID: 24944027 BACKGROUND

• 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.

  PMID: 1657498 BACKGROUND

• 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.

  PMID: 9308783 BACKGROUND

• 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.

  PMID: 12215328 BACKGROUND

• 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.

  PMID: 25309860 BACKGROUND

MeSH Terms

Conditions

Ovarian Hyperstimulation Syndrome

Interventions

Bromocriptine

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Ergotamines; Ergot Alkaloids; Alkaloids; Heterocyclic Compounds; Ergolines; Heterocyclic Compounds, 4 or More Rings; Heterocyclic Compounds, Fused-Ring

Study Officials

• Muhammad S Zeafan, MBBCH

  Ganin Fertility Center

  PRINCIPAL INVESTIGATOR

• khaled M Elqusi, BSc

  Ganin Fertility Center

  PRINCIPAL INVESTIGATOR

• Hossam Elattar, MBBCH

  Ganin Fertility Center

  PRINCIPAL INVESTIGATOR

• Hosam Zaki, MSc, FRCOG

  Ganin Fertility Center

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: April 14, 2020
• First Posted: April 17, 2020
• Study Start: April 1, 2019
• Primary Completion: February 25, 2020
• Study Completion: February 29, 2020
• Last Updated: April 17, 2020

Record last verified: 2020-04

Data Sharing

• IPD Sharing: Will not share

Locations

EG (1)